[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cancer-pain\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cancer-pain":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,31,0,25,[9,44,70,95,117,139,168,196,219,250,277,304,408,437,467,494,515,544,580,607,632,655,684,720,741],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100522645","cancer-pain-management-using-a-web-based-intervention-100522645",false,"NCT06085313","Cancer Pain Management Using a Web-based Intervention","Cancer Pain Management: A Technology-Based Intervention for Asian American Breast Cancer Survivors","CAI","Inclusion Criteria:\n\n* women aged 18 years and older who identify as Chinese, Korean, or Japanese;\n* have had a breast cancer diagnosis in the past;\n* can read and write English, Mandarin (simplified or traditional), Korean, or Japanese;\n* have access to the internet through computers or mobile devices (mobile phones and tablets);\n* have experienced cancer pain during the past week (at least 1 on a scale from 0 to 5 \\[no symptom=0, mild symptom that does not bother=1, somewhat bothering symptom=2, moderate symptom=3, severe symptom=4, and worst possible symptom=5\\]);\n* have experienced depressive symptoms during the past two weeks (1 to 10 on the Patient Health Questionnaire) which is equivalent to the cut-point of minimal to moderate depression.\n\nExclusion Criteria:\n\n* less than 18 years old because their cancer experience would be different from that of adults.\n* Those who are in treatment or not in treatment, but who were diagnosed with breast cancer within the past five years, will be excluded.\n* Those who participated in the PI's pilot studies will be excluded.\n* The participants of R33 phase will exclude those in active depression treatment regardless of their level of depression.\n* Those without Internet access will be excluded, but those with Internet access through community\u002Fgroup computers will be included.","FEMALE","18 Years",{"count":21,"type":22},300,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study is funded by the HEAL Initiative (https:\u002F\u002Fheal.nih.gov\u002F). Based on Preliminary Studies (PSs), the research team developed and pilot-tested an evidence-based Web App-based information and coaching\u002Fsupport program for cancer pain management (CAPA) that was culturally tailored to Asian American breast cancer survivors using multiple unique features. However, CAPA rarely considered depressive symptoms accompanying pain in its design or components, and PSs indicated the necessity of further individualization of the intervention components of CAPA due to diversities in the needs of ABD. The purpose of the proposed 2-phase study is to further develop CAPA with additional components for ABD and the individual optimization functionality (CAI) and to test the efficacy of CAI in improving cancer pain experience of ABD. The specific aims are to: a) develop and evaluate CAI through an expert review and a usability test (R61 phase); b) determine whether the intervention group (that uses CAI and usual care) will show significantly greater improvements than the active control group (that uses CAPA and usual care) in primary outcomes (cancer pain management and cancer pain experience including depressive symptoms) from baseline to post 1-month and post 3-months; c) identify theory-based variables (attitudes, self-efficacy, perceived barriers, and social influences) that mediate the intervention effects of CAI on the primary outcomes; and d) determine whether the effects of CAI on the primary outcomes are moderated by selected background, disease, genetic, and situational factors. This study is guided by the Bandura's Theory and the stress and coping framework by Lazarus and Folkman. The R61 phase includes: (a) the intervention development process, (b) a usability test among 15 ABD, 15 family members, and 15 community gatekeepers; and (c) an expert review among 10 experts in oncology. The R33 phase adopts a randomized repeated measures control group design among 300 ABD. Long-term goals are: (a) to extend and test CAI in various healthcare settings with diverse subgroups of ABD, (b) examine the costeffectiveness, sustainability, and scalability of CAI in the settings, and (c) translate CAI into health care for ABD.",[28,29,30],"Cancer of Breast","Depressive Symptoms","Cancer Pain","RECRUITING","2026-06-06",{"date":34,"type":35},"2026-06-09","ACTUAL",{"date":37,"type":35},"2024-02-20",{"date":39,"type":22},"2027-08-31",{"name":41,"class":42},"University of Texas at Austin","OTHER",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":43},"100638931","rad-onc-freedom-oncology-pain-100638931","NCT07605546","RAD ONC FREEDOM Oncology Pain","Functional Radiosurgery for Easing or Eliminating Debilitating Oncologic Morbidity (FREEDOM)","FREEDOM","Inclusion Criteria:\n\n1. Male or female ≥ 18 years of age on day of SRS treatment.\n2. Documentation of insufficiently controlled mixed, complex cancer pain based on Brief Pain Inventory (BPI) \\>8\u002F10 despite optimization of opioid regimen\n3. Not eligible for or willing to undergo further pain-relieving interventions\n4. Written informed consent (and assent when applicable) obtained from patient or patient's legal representative and ability for patient to comply with the study requirements and agree to undergo the study's SRS treatment plan.\n\nExclusion Criteria:\n\n1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.\n2. Claustrophobia or inability to life flat\n3. Inability to undergo routine imaging studies\n4. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.\n5. Current history of intracranial malignancy or brain metastasis\n6. Any prior intracranial irradiation\n7. Previous history of craniotomy, deep brain stimulation (DBS) or laser interstitial themal therapy (LITT).\n8. Presence of intracranial hardware such as leads for DBS or any other material that may interfere with safe treatment.\n9. Any comorbidity or condition which would limit full compliance with the protocol","ALL",{"count":54,"type":22},19,[25],"The investigators propose to conduct a study in medically refractory cancer pain patients utilizing radiosurgery to ablate the pituitary hypophysis, as well as neuromodulate the centromedian and parafascicular complexes within the thalami - the so-called triple target. This involves treating the pituitary hypophysis and thalamus to a dose of 90 Gy. These patients will have previously failed to achieve adequate pain control with opioid pain regimens and interventional approaches. The trial will involve a multidisciplinary approach involving radiation oncology, neurosurgery, palliative care, and medical oncology colleagues across UCLA.",[30],[59],"reduction","NOT_YET_RECRUITING","2026-06-03",{"date":63,"type":35},"2026-06-04",{"date":65,"type":22},"2026-06-05",{"date":67,"type":22},"2029-06-01",{"name":69,"class":42},"Jonsson Comprehensive Cancer Center",{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":23,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100535160","virtual-reality-therapy-for-cancer-treatment-associated-symptoms-100535160","NCT06248216","Virtual Reality Therapy for Cancer-Treatment Associated Symptoms","Implementation of an At-Home Multimodal Integrative Therapy Via Virtual Reality for Patients With Cancer-Treatment Associated Symptoms","Inclusion Criteria:\n\n* Adults ages 18-88\n* Cancer diagnosis (histology verified)\n* Had surgical intervention, completed chemotherapy or radiation for therapeutic purposes\n\n  -\\>3 months since last cancer treatment, but participants currently undergoing endocrine or immunotherapy treatments are permissible\n* Documented symptoms of cancer or cancer therapy including at least one of the following: pain, anxiety, sleep difficulty, fatigue, neuropathy\n* English speaker (written and spoken)\n\nExclusion Criteria:\n\n* Severe psychiatric condition (e.g. schizophrenia, bipolar disorders, autism) leading to hospitalization within the last 3 years\n* Any personal (or family first degree) history of mania, schizophrenia, or other psychoses\n* Diagnosis and treatment of chronic pain, neuropathy, fatigue, sleep or anxiety disorder prior to cancer diagnosis\n* Current Hospice or palliative care only recipients\n* Color-blindness\n* Impaired or uncorrected hearing\n* Lifetime alcohol\u002Fdrug dependence or alcohol\u002Fdrug abuse in past 3 months\n* Conditions that would interfere with the VR mask placement (e.g. trauma, burn, infection)\n* Known history of severe motion sickness\n* Pregnancy or breast feeding","88 Years",{"count":79,"type":22},30,[25],"We propose an innovative approach to symptom management in cancer patients following cancer treatments, utilizing a Multimodal Integrative Therapy (MIT) delivered via Virtual Reality (VR) program, authorized by the US Food and Drug Administration for in-home use. Our primary goal is to generate pilot data on the effects of MIT-VR program on pain, fatigue, sleep, depression, and anxiety in participants suffering from chronic cancer symptoms following cancer treatments.",[83,30,84],"Cancer","Virtual Reality","2026-04-27",{"date":87,"type":35},"2026-04-29",{"date":89,"type":35},"2024-12-04",{"date":91,"type":22},"2027-12",{"name":93,"class":42},"University of Maryland, Baltimore",2,{"id":96,"slug":97,"hasResults":12,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":12,"sex":52,"minAge":4,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":23,"phases":104,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":43},"100567113","phase-3-a-randomized-controlled-trial-of-a-web-based-platform-for-cancer-pain-management-100567113","NCT06663956","A Randomized Controlled Trial of a Web-based Platform for Cancer Pain Management","A Randomized Controlled, Open Clinical Trial of a Web-based Platform for Multifactorial Intervention in Cancer Pain Management","Inclusion Criteria:\n\n* Patients with tumors that are confirmed by pathological findings.\n* Presence of tumor-related pain that is moderate or higher and requires intervention with morphine-based pain medication (++).\n* Have a life expectancy of more than 6 months.\n* Understand and sign a consent to participate in the study, or if the patient is unable to understand the study, his\u002Fher direct caregiver must have a good understanding of the study.\n\nExclusion Criteria:\n\n* Presence of other chronic non-cancer pain\u002Fhave an unresolved pain-related condition.\n* Moderately severe cognitive impairment\u002Fcognitive impairment.\n* Have schizophrenia or other psychiatric illness.\n* Neither the patient nor his\u002Fher direct caregiver can understand how to use the Cancer Pain Management applet.\n* Being pregnant.",{"count":103,"type":22},100,[105],"PHASE3","Malignant tumors are one of the major public health problems in China, and cancer pain is a common symptom in tumor patients, affecting the quality of life. In rural areas, cancer pain management is challenging due to insufficient medical resources and limitations in understanding cancer pain. Investigators plan to develop a convenient patient self-reporting applet to help participants report their symptoms to primary care physicians promptly and monitor pain levels and medication in real-time. This project aims to improve the efficiency of cancer pain management, integrate cancer pain into chronic disease management, improve the quality of healthcare services for rural participants, and promote the construction of a healthy China.",[30],"2026-04-24",{"date":110,"type":35},"2026-04-30",{"date":112,"type":35},"2024-11-10",{"date":114,"type":22},"2026-11-10",{"name":116,"class":42},"West China Hospital",{"id":118,"slug":119,"hasResults":12,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":23,"phases":126,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":43},"100631190","enhancing-pain-management-among-patients-diagnosed-with-stage-iii-and-stage-iv-of-breast-cancer-the-power-of-immersive-and-non-immersive-virtual-reality-driven-interactive-guided-imagery-100631190","NCT07497451","Enhancing Pain Management Among Patients Diagnosed With Stage III and Stage IV of Breast Cancer: The Power of Immersive and Non-Immersive Virtual Reality-Driven Interactive Guided Imagery","Enhancing Pain Management Among Patients Diagnosed With Stage III and Stage IV of Breast Cancer: The Power of Non-Immersive Virtual Reality-Driven Interactive Guided Imagery: A Randomized Controlled Trial (RCT)","Inclusion Criteria\n\n* Patients diagnosed with advanced stage of breast cancer; based on pathological analysis (this Data from electronic medical record system).\n* Undergoing treatment in the selected Hospital\n* Age group \\>18 years of age (Adult)\n* Hospitalized patient at the selected study setting\n* Available at the time of data collection; the minimum expected admission time should be no less than 5 days, as the intervention is planned to last for 5 days.\n* Able to sign the consent form.\n* Willing to comply with study procedures and instructions.\n* has cancer pain. Exclusion Criteria\n* Individuals who are experiencing difficulties in their ability to hear or have a complete loss of hearing.\n* Individuals who suffer from extreme visual impairment or complete loss of vision.\n* Not willing to participate in the study.\n* Patient with Glasgow coma scale \\\u003C 15\n* Individuals who experience persistent and uncontrollable feelings of nausea, vomiting, or dizziness, individuals with a background of motion sickness (Rational for exclusion: According to previous studies, the utilization of VR intervention may have adverse effects, including Dizziness, nausea, vomiting, and motion sickness (Simón-Vicente et al., 2022).As a result, in order to prevent the exacerbation of these symptoms among patients, they will not be included in the VR intervention)\n* Individuals with a history of seizures or epilepsy (Rational for exclusion: Individuals diagnosed with epilepsy have frequently been excluded from the participation in virtual reality (VR) research due to the concern that engaging with VR technology could potentially induce seizures in those who have photosensitive epilepsy (Gray et al., 2023)\n* A patient who has an injury at their eyes, face, or neck that hinders their ability to comfortably utilize virtual reality (VR) hardware or software or poses a safety risk when using the hardware (such as having open sores, wounds, or a skin rash on their face).",{"count":125,"type":22},90,[25],"Cancer-related pain is one of the most common and distressing symptoms experienced by patients with advanced cancer, particularly among women diagnosed with advanced breast cancer. Pain associated with cancer may arise from tumor progression, metastasis, or cancer treatments, and it often has a substantial negative impact on patients' physical functioning, emotional well-being, and overall quality of life. Although pharmacological pain management strategies remain the primary approach for managing cancer-related pain, many patients continue to report inadequate pain relief or experience undesirable side effects from medications. For this reason, healthcare providers and researchers are increasingly exploring complementary and non-pharmacological interventions that can be used alongside standard pain management strategies.\n\nCurrent clinical practice for cancer pain management commonly follows the analgesic ladder recommended by the World Health Organization, which involves a stepwise approach using non-opioid analgesics, weak opioids, and strong opioids depending on the severity of the patient's pain. While this approach has significantly improved pain control in many patients, it does not completely eliminate pain in all cases, and additional supportive interventions are often required. In recent years, digital health technologies such as virtual reality (VR) have emerged as promising tools that may support pain management through distraction, relaxation, and cognitive engagement.\n\nVirtual reality is an interactive computer-generated environment that can simulate real or imaginary settings and allow users to experience immersive or semi-immersive sensory stimulation. VR-based interventions have gained increasing attention in healthcare due to their potential to reduce pain perception by diverting attention away from painful stimuli and promoting psychological relaxation. In particular, VR-assisted guided imagery interventions have been proposed as a therapeutic approach that combines visual and auditory stimuli with relaxation techniques to enhance patients' cognitive engagement and emotional comfort.\n\nVR technology can be delivered through different levels of immersion. Immersive VR typically uses a head-mounted display to create a fully interactive three-dimensional environment that surrounds the user and blocks out external stimuli, providing a highly engaging experience. In contrast, non-immersive VR systems present virtual environments through computer screens or similar devices, allowing users to remain aware of their physical surroundings while interacting with digital content. Although both approaches may contribute to pain reduction through distraction and relaxation mechanisms, limited evidence exists regarding the comparative effectiveness of immersive versus non-immersive VR interventions in the management of cancer-related pain.\n\nTherefore, the purpose of this study is to evaluate the effectiveness of immersive and non-immersive virtual reality-assisted guided imagery interventions in reducing cancer-related pain among patients with advanced breast cancer in Jordan. The study aims to determine whether these interventions can provide additional benefits when used alongside standard cancer pain management practices.\n\nThis study will employ a quantitative quasi-experimental pre-post design with three study groups: an immersive virtual reality intervention group, a non-immersive virtual reality-assisted guided imagery group, and a control group receiving standard cancer pain management care. Participants in both intervention groups will engage in a 45-minute virtual reality session consisting of guided imagery experiences designed to promote relaxation and distraction from pain. The immersive VR group will use head-mounted display technology to experience a fully immersive 360-degree virtual environment, while the non-immersive VR group will view similar virtual content using a computer-based display system with audio support.\n\nPain intensity will be measured using the Arabic version of the Numerical Pain Rating Scale (NPRS) before the intervention and immediately after the intervention. In addition, symptoms associated with simulator sickness, such as nausea, dizziness, and visual discomfort, will be assessed using the Simulator Sickness Questionnaire (SSQ) to evaluate the safety and tolerability of the VR interventions.\n\nThe study will be conducted among adult patients diagnosed with advanced breast cancer who are receiving care at a cancer pain management clinic in a large public hospital in Jordan. Eligible participants will be adults aged 18 years or older who are experiencing cancer-related pain and are able to participate in the intervention sessions. A total of 90 participants will be recruited and allocated equally across the three study groups.\n\nThe findings of this study are expected to contribute to the growing body of evidence regarding the role of virtual reality technologies in suppo",[30,129],"Virtual Reality Immersion","2026-03-24",{"date":132,"type":35},"2026-03-27",{"date":134,"type":22},"2026-03-20",{"date":136,"type":22},"2026-07-20",{"name":138,"class":42},"Middle East University",{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":52,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":23,"phases":149,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":43},"100630588","early-phase-1-hydromorphone-with-electroacupuncture-and-ear-acupoint-pressing-for-refractory-cancer-pain-100630588","NCT07489625","Hydromorphone With Electroacupuncture and Ear Acupoint Pressing for Refractory Cancer Pain","Observation on the Clinical Efficacy of Hydromorphone Hydrochloride Sustained-Release Tablets Combined With Electroacupuncture and Ear Acupoint Pressing Beans in the Treatment of Refractory Cancer Pain","Inclusion Criteria:\n\n1. Patients who meet the diagnostic criteria for cancer ;\n2. Diagnosis of refractory cancer pain;\n3. Aged 19 or 80 years;\n4. Expected survival period ≥3 months;\n5. Karnofsky Performance Status (KPS) score ≥30 and Quality of Life (QOL) score ≥20;\n6. No history of allergy to opioid analgesics;\n7. No intellectual or psychiatric disorders; normal comprehension ability,capable of cooperating with pain assessments and questionnaire completion;\n8. Provision of signed written informed consent.\n\nExclusion Criteria:\n\n1. Patients with pain clearly unrelated to the tumor itself;\n2. Patients with pain relief after standardized pharmacological treatment;\n3. Patients aged under 19 years or over 80 years;\n4. Patients with an expected survival of less than 3 months;\n5. Patients with a Karnofsky Performance Status (KPS) score \\\u003C 30 or Quality of Life (QOL) score \\\u003C 20;\n6. Pregnant or lactating women;\n7. Patients with intellectual disability, mental or consciousness disturbance, who are unable to assess pain accurately or complete questionnaire surveys;\n8. Patients with needle phobia or extreme resistance to acupuncture treatment;\n9. Patients with hypersensitivity to Semen Vaccariae (Wang Bu Liu Xing).","19 Years","80 Years",{"count":79,"type":22},[150],"EARLY_PHASE1","This trial aims to address refractory cancer pain (RCP). It will explore the synergistic efficacy and safety of hydromorphone hydrochloride sustained-release tablets (HHST) combined with electroacupuncture (EA) and ear acupoint pressing beans (EAPB) for RCP. Key outcomes will include dynamic changes in Numerical Rating Scale (NRS) scores, proportions of patients with effective analgesia (≥30% NRS reduction from baseline) and marked remission (≥50% NRS reduction from baseline), daily HHST dosage, breakthrough pain (BP) frequency, and drug-related adverse events (AEs) graded by CTCAE 5.0.",[153,30],"Refractory Cancer Pain",[155,156,157,158,159],"electroacupuncture","ear acupoint pressing beans","hydromorphone","refractory cancer pain","cancer pain","2026-03-18",{"date":130,"type":35},{"date":163,"type":22},"2026-03-07",{"date":165,"type":22},"2028-12-31",{"name":167,"class":42},"Qinghai Red Cross Hospital",{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":174,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":23,"phases":176,"briefSummary":177,"conditions":178,"keywords":181,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":4},"100628464","evaluation-of-the-effects-of-traditional-and-e-learning-methods-in-cancer-pain-care-education-on-learning-outcomes-and-institutional-costs-100628464","NCT07461974","Evaluation of the Effects of Traditional and E-Learning Methods in Cancer Pain Care Education on Learning Outcomes and Institutional Costs","Inclusion Criteria:\n\n* Students who have access to the internet and a computer\u002Fmobile phone,\n* Students who have successfully completed the Fundamentals of Nursing course,\n* Students who are taking the Internal Medicine Nursing course for the first time,\n* Students who voluntarily agree to participate in the study.\n\nExclusion Criteria:\n\n* Students who are repeating the Internal Medicine Nursing course,\n* Students who have taken the Palliative Care and Nursing or Oncology Nursing courses,\n* Students who have been diagnosed with cancer themselves or have a relative diagnosed with cancer,\n* Students who were admitted to the nursing department through the Vertical Transfer Exam (DGS) after graduating from an associate degree program in a health-related field,\n* Students who graduated from a Vocational Health High School,\n* Students who were admitted through the International Student Examination.",true,{"count":103,"type":22},[25],"Cancer pain is a significant clinical problem that directly affects patients' quality of life and requires nurses to be equipped with adequate knowledge and skills to provide effective care. The current shift in knowledge and skill acquisition from traditional teaching methods toward e-learning-based approaches has increased the importance of comparing the effects of these educational methods on learning outcomes in cancer pain management education.\n\nWithin this context, the course content on cancer pain management will be developed using both traditional and e-learning methods based on the ADDIE instructional design model. The effects of these two methods on students' learning outcomes and institutional teaching costs will be evaluated. Thus, this study aims to contribute to identifying effective and cost-efficient teaching strategies in nursing education.",[30,179,180],"Nursing Students","Nursing Education",[182,183,184,185,186],"Nursing","Traditional Learning Methods","E-Learning Methods","Education","Cost","2026-03-09",{"date":189,"type":35},"2026-03-10",{"date":191,"type":22},"2026-06-01",{"date":193,"type":22},"2026-12-31",{"name":195,"class":42},"Bilecik Seyh Edebali Universitesi",{"id":197,"slug":198,"hasResults":12,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":23,"phases":205,"briefSummary":207,"conditions":208,"keywords":209,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":216,"locationsCount":4},"100459625","phase-2-3d1002-in-combination-with-oxycodone-hydrochloride-sustained-release-tablets-in-patients-with-moderate-to-severe-cancer-pain-100459625","NCT05265052","3D1002 in Combination With Oxycodone Hydrochloride Sustained-release Tablets in Patients With Moderate to Severe Cancer Pain","A Multicenter, Randomized, Phase IIa\u002FIIb Clinical Trial of 3D1002 Combined With Oxycodone Hydrochloride Sustained-release Tablets in the Treatment of Patients With Moderate to Severe Cancer Pain","Inclusion Criteria:\n\n1. Subject must sign the informed consent in person prior to beginning any screening procedure.\n2. Age ≥18, both male and female.\n3. Subjects with a malignant tumor confirmed by histopathology or cytology.\n4. Weight ≥40 kg at screening period.\n5. Subjects have relatively stable cancer pain and require continuous analgesic medications (estimated treatment duration ≥2 weeks), as assessed by the investigator.\n6. Estimated life expectancy ≥3 months.\n7. Subjects are willing to not use any analgesic other than those specified in the study during the study treatment period.\n8. ECOG PS score is 0-3.\n9. Have adequate organ and bone marrow function.\n10. The mean NRS scores per day during the washout period are ≥4.\n\nExclusion Criteria:\n\n1. Known allergy to any of the active ingredients or excipients of the study drug, or have a history of allergy to other opioids or non-steroidal anti-inflammatory drugs (NSAIDs) and their related ingredients.\n2. Have a persistent pain resulted from other medical conditions or unknown causes.\n3. Subjects presenting with emergency symptoms such as intestinal obstruction\u002Fperforation, spinal cord compression, epidural metastasis, or fracture.\n4. Subjects with known active\u002Fsymptomatic central nervous system metastasis and\u002For cancerous meningitis.\n5. Subjects plan to be treated with \\>10 mg\u002F day of prednisone or equivalent systemic corticosteroid during the study period.\n6. Have a history of gastrointestinal bleeding or perforation.\n7. Have a positive result of fecal occult blood test during screening period.\n8. Have a history of serious cardiovascular diseases.\n9. Have a history of an acute ischemic or hemorrhagic stroke within 6 months prior to screening.\n10. Have a history of significant psychiatric disorders, such as schizophrenia and depression.\n11. Subjects plan to receive radiotherapy, surgery, or a new regimen of systemic antitumor agents during the study treatment period (D1-D15).\n12. Subjects have a history of alcohol abuse or drug abuse including opioids.\n13. Subjects have significant opioid contraindications.\n14. Pregnant or lactating women.\n15. Subjects with other diseases that affect the oral administration or absorption of drugs.\n16. Subjects are currently participating in another clinical study.\n17. Other conditions deemed by the investigator to be inappropriate for participation in this study, such as poor compliance.",{"count":204,"type":22},177,[206],"PHASE2","This study aims to evaluate the safety and efficacy of 3D1002 alone or in combination with oxycodone hydrochloride sustained-release tablets (OxyContin) for the management of moderate or severe cancer pain.",[30],[210],"Cancer pain",{"date":212,"type":35},"2026-03-11",{"date":214,"type":22},"2026-12",{"date":214,"type":22},{"name":217,"class":218},"3D Medicines","INDUSTRY",{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":23,"phases":228,"briefSummary":230,"conditions":231,"keywords":234,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":249},"100627378","phase-1-a-study-testing-topical-pain-relieving-herbal-plasters-in-people-who-are-using-opioids-for-their-pain-100627378","NCT07447856","A Study Testing Topical Pain-Relieving Herbal Plasters in People Who Are Using Opioids for Their Pain","Integrating Topical Herbal Plasters to Enhance Pain Management and Reduce Opioid Use in Cancer Patients (EASE)","Inclusion Criteria:\n\n* English speaking with age ≥ 18 years or older\n* A diagnosis of cancer with no restrictions placed on type of cancer or stage. Eligibility criteria will not be restricted to MSK confirmed biopsy\u002Fdiagnosis. Outside institution's testing is sufficient.\n* Ambulatory (Karnofsky Performance Status of ≥ 60)\n* Having one of three types of pain (e.g., musculoskeletal pain, bone metastasis pain, and visceral\u002Fabdominal pain) and the worst pain area can be covered by one patch of topical herbal plaster\n* Worst pain score (measured by the 0-10 numeric pain rating scale) 4 or above in the preceding week\n* Current use of short-term oral opioids (i.e. oxycodone, morphine immediate release, or hydromorphone) for pain management.\n* Willingness to adhere to and understanding of all study-related procedures, including randomization to one of the two possible study arms\n* Able to understand informed consent and provide signed informed consent form\n\nExclusion Criteria:\n\n* Patients are unwilling to reduce opioid use if their pain reduces\n* Patients have generalized musculoskeletal pain such as fibromyalgia as primary source of pain\n* Patients with clinician confirmed significant skin disorders such as severe eczema, psoriasis, severe xerosis, chronic dermatitis, or adhesive allergy.\n* Patients with open wounds, infections, skin trauma at skin overlying area of pain\n* Patients with documented history of skin sensitivity to adhesive or allergic reaction to other patches or topical analgesics\n* Patients with documented skin allergic reaction to plants or herbs\n* Patients who are unwilling to hold their current localized topical pain treatment (such as lidocaine patch) for the most severe pain site.\n* Patients who undergo initiation or change in pain management strategies within 1 week prior to enrollment, including oral analgesics (e.g., opioids, NSAIDs), medications that can significantly reduce pain (e.g., bisphosphonates, denosumab), or interventional procedures (e.g., nerve blocks, palliative radiation).\n* Patients who are planned to undergo initiation or change of the above pain management strategies in the 2 weeks following enrollment.\n* Patients who undergo initiation or change in standard cancer treatments (surgery, radiation, chemotherapy, hormonal therapy, immunotherapy, or targeted therapy) 1 week prior to enrollment.\n* Patients who are planned to undergo initiation or change of active cancer treatments (surgery, radiation, chemotherapy, hormonal therapy, immunotherapy, or targeted therapy) in the 2 weeks following enrollment.",{"count":227,"type":22},150,[229],"PHASE1","The are doing this study to find out whether using topical (on the skin) herbal plasters, Tibetree pain- relieving plasters (PRPs), can be an effective addition to standard opioid therapy for pain management. The researchers will look at whether the Tibetree PRPs are a practical (feasible) and effective way of managing localized pain (pain that is limited to a certain area) in people who are currently taking opioids. Participants in this study will have cancer or have had it in the past.",[232,233,30],"Cancer Patients","Survivor Patients",[235,236,83,237,238,239],"Tibetree","Tibetree Pain-Relieving","Pain","Cancer survivor","25-376","2026-02-25",{"date":242,"type":35},"2026-03-04",{"date":244,"type":35},"2026-02-23",{"date":246,"type":22},"2028-02",{"name":248,"class":42},"Memorial Sloan Kettering Cancer Center",7,{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":23,"phases":259,"briefSummary":260,"conditions":261,"keywords":262,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":43},"100627188","transdiscal-vs-paravertebral-neurolytic-splanchnic-nerve-block-for-upper-abdominal-cancer-pain-100627188","NCT07445386","Transdiscal vs Paravertebral Neurolytic Splanchnic Nerve Block for Upper Abdominal Cancer Pain","Comparison of Transdiscal and Paravertebral Approaches for Neurolytic Splanchnic Nerve Block in the Treatment of Upper Abdominal Cancer Pain","Inclusion Criteria:\n\n* Severe abdominal pain (NRS \\> 6) due to upper intra-abdominal organ malignancies (such as gastric, pancreatic, or hepatic cancer).\n* Failure of pain control with conservative treatment modalities.\n\nExclusion Criteria:\n\n* Presence of local anatomical variations\n* Localized or systemic infection involving the procedural site\n* Pregnancy\n* Coagulopathy\n* Presence of unstable psychiatric disorders",{"count":258,"type":22},56,[25],"This study aims to compare the efficacy of fluoroscopy-guided paravertebral (PV) and transdiscal (TD) approaches for splanchnic nerve neurolysis in patients with upper abdominal cancer-related pain (e.g., gastric, pancreatic, and hepatic malignancies). Treatment response will be assessed using the Numerical Rating Scale (NRS), and the impact of both techniques on quality of life will be evaluated with the EORTC QLQ-C30 questionnaire.",[30],[263,264,265,266,267],"Splanchnic Nerves","Nerve Block","Abdominal Pain","Pancreatic Neoplasms","Liver Neoplasms",{"date":269,"type":35},"2026-03-03",{"date":271,"type":35},"2026-02-16",{"date":273,"type":22},"2026-09-16",{"name":275,"class":276},"Ankara Etlik City Hospital","OTHER_GOV",{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":52,"minAge":284,"maxAge":4,"enrollmentInfo":285,"targetDuration":287,"studyType":288,"phases":4,"briefSummary":289,"conditions":290,"keywords":293,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":298,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":302,"locationsCount":43},"100625364","assessing-hydromorphone-sustained-release-tablets-in-elderly-cancer-pain-patients-with-renal-insufficiency-100625364","NCT07421674","Assessing Hydromorphone Sustained-Release Tablets in Elderly Cancer Pain Patients With Renal Insufficiency","Application Research of Hydromorphinone Sustained-release Tablets in the Treatment of Elderly Patients With Cancer Pain Accompanied by Renal Insufficiency","Inclusion Criteria:\n\n1. Age ≥ 65 years.\n2. Pathologically or cytologically confirmed malignant tumor.\n3. Opioid-naïve patients with moderate-to-severe cancer pain (Numerical Rating Scale score ≥ 4).\n4. Renal function meeting one of the following criteria at baseline:\n\n1）Mild-to-moderate renal insufficiency group: 30 mL\u002Fmin\u002F1.73m² ≤ estimated glomerular filtration rate (eGFR) \\\u003C 90 mL\u002Fmin\u002F1.73m².\n\n2）Normal renal function group: eGFR ≥ 90 mL\u002Fmin\u002F1.73m². 5.Expected survival period ≥ 3 months. 6.Ability to take oral medication and cooperate with study assessments. 7.Willing to participate voluntarily and able to provide signed informed consent.\n\nExclusion Criteria:\n\n1. Severe renal insufficiency (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m²) or requirement for renal replacement therapy.\n2. Severe hepatic insufficiency (alanine aminotransferase \u002F aspartate aminotransferase ≥ 2.5 times the upper limit of normal or Child-Pugh Class C).\n3. Paralytic ileus.\n4. Pain of unclear origin or pain that is solely acute\u002Fincident pain.\n5. Symptoms or history of diseases such as intracranial hypertension, head injury, cerebral aneurysm, or other central nervous system disorders.\n6. Symptoms of prostatic hypertrophy, thyroid dysfunction, or urethral stricture. Symptoms of asthma, respiratory obstruction, or respiratory failure.\n7. Known allergy or hypersensitivity to hydromorphone or oxycodone.\n8. Use of monoamine oxidase inhibitors within 14 days prior to enrollment.\n9. Participation in any other clinical trial within 1 month prior to enrollment.\n10. Any other condition considered by the investigator as unsuitable for participation in this study.","65 Years",{"count":286,"type":22},62,"4 Weeks","OBSERVATIONAL","This clinical study aims to understand whether domestic hydromorphinone sustained-release tablets are effective and safe in treating moderate to severe cancer pain in elderly patients with renal insufficiency.\n\nIt will also understand key safety concerns, especially regarding renal function and neurotoxicity.\n\nThe main questions it aims to answer include:1. Can hydromorphinone sustained-release tablets effectively relieve the pain of such patients and improve their quality of life?2. During the treatment period, what effect does this drug have on renal function (measured by eGFR)? 3. In this specific population, what are the occurrence and characteristics of neurotoxicity and other side effects induced by opioids? Researchers will compare elderly cancer pain patients with renal insufficiency with those with normal renal function (both receiving the study drug treatment) to observe whether there are differences in efficacy and safety results.\n\nParticipants will:\n\nReceive a standardized treatment plan: First, subcutaneous injection of hydromorphinone injection for dose titration, and then switch to daily oral administration of hydromorphinone sustained-release tablets for 4 weeks.\n\nVisit the clinic for assessment and examination (including renal function tests) during the baseline period, on the 7th day, and at the weekends of the 2nd, 3rd, and 4th days.\n\nRegularly monitor and record the degree of pain, the occurrence of explosive pain, the use of medication, and any side effects.",[30,291,292],"Renal Insufficiency Chronic","Hydromorphone Use",[30,294,295,296,297],"Renal Insufficiency","Aged","Hydromorphone","Opioid-Induced Neurotoxicity",{"date":240,"type":35},{"date":300,"type":22},"2026-02-10",{"date":165,"type":22},{"name":303,"class":42},"Taian Cancer Hospital",{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":311,"enrollmentInfo":312,"targetDuration":4,"studyType":23,"phases":314,"briefSummary":315,"conditions":316,"keywords":395,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":43},"100432171","virtual-reality-for-gi-cancer-pain-to-improve-patient-reported-outcomes-100432171","NCT04907643","Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes","Randomized Controlled Trial of Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes","Inclusion Criteria:\n\n* Have a primary malignancy of the biliary tract, colon, liver, pancreas, peritoneum, rectum, small intestine, or stomach, with no plan for resection during the study period\n* Tumor types including, but not limited to, adenocarcinoma, squamous cell carcinoma, neuroendocrine tumors, and tumors of mesenchymal origin will be eligible\n* Have clinically significant visceral pain, measured using the standardized NIH PROMIS GI Pain Scale defined as scoring at least 5 points above the nationally normed score\n* Ability to read and write in English\n\nExclusion Criteria:\n\n* Have a condition that interferes with VR usage, including but not limited to seizures, facial injury precluding safe placement of headset, and visual impairments\n* Have cognitive impairment that affects protocol participation. This will be done with a three part cognitive assessment during the initial phone call to assess eligibility followed by consent discussion if eligible.\n* Have brain metastases\n* Have a prognosis of \\\u003C3 months from the time of enrollment per treating oncologist","99 Years",{"count":313,"type":22},360,[25],"Patients with digestive tract malignancy often experience severe and unremitting abdominal pain that negatively affects physical, emotional, and social function, as well as health related quality of life (HRQOL). Therapeutic virtual reality (VR) has emerged as a promising and evidence-based treatment modality for cancer pain. Users of VR wear a pair of goggles with a close-proximity screen in front of the eyes that creates a sensation of being transported into lifelike, three-dimensional worlds. To date, VR has been limited to short-term clinical trials for cancer pain. Moreover, limited research exists on theory-based VR modalities beyond mere distraction, such as VR that employs acceptance and commitment therapy (ACT) with components of biofeedback and mindfulness. To bridge these gaps, this study seeks to: (1) assess the impact of immersive VR on patient-reported outcomes (PROs), including pain, activity metrics, and opioid use among patients with visceral pain from a digestive tract malignancy; (2) assess differences in PROs, activity metrics, and opioid use between skills-based VR therapy vs. distraction VR therapy; and (3) determine patient-level predictors of VR treatment response in visceral cancer pain.\n\nTo address these aims, the study will measure PROs and opioid use in 360 patients randomized among 3 groups and follow them for 60 days after enrollment: (1) an enhanced VR group receiving skills-based VR; (2) a distraction-based VR group receiving patient-selected VR videos; and (3) a VR sham control group using a VR headset with 2-D content. The results will inform best practices for the implementation of VR for visceral cancer pain management and guide selection of patient-tailored experiences.",[30,317,318,319,320,321,322,323,324,325,326,327,328,329,330,331,332,333,334,335,336,337,338,339,340,341,342,343,344,345,346,347,348,349,350,351,352,353,354,355,356,357,358,359,360,361,362,363,364,365,366,367,368,369,370,371,372,373,374,375,376,377,378,379,380,381,382,383,384,385,386,387,388,389,390,391,392,393,394],"Visceral Pain","Gastrointestinal Neoplasms","Cancer of Gastrointestinal Tract","Small Intestine Cancer","Pancreas Cancer","Liver Cancer","Colon Cancer","Biliary Tract Cancer","Stomach Cancer","Rectum Cancer","Peritoneal Cancer","Gastrointestinal Cancer Metastatic","Gastrointestinal Cancers - Anus","Gastrointestinal Cancers - Stomach","Gastrointestinal Cancers - Colorectal","Gastrointestinal Cancers - Small Intestine","Small Intestine Cancer Stage III","Small Intestine Cancer Stage IV","Small Intestine Cancer, Recurrent","Pancreas Cancer, Stage III","Pancreas Cancer, Stage IV","Pancreas Cancer, Metastatic","Pancreas Cancer, Recurrent","Liver Cancer Stage IIIa","Liver Cancer Stage IIIb","Liver Cancer Stage IIIc","Liver Cancer Stage IV","Colon Cancer Stage III","Colon Cancer Stage IV","Stomach Cancer Stage III","Stomach Cancer Stage IV","Stomach Cancer Recurrent","Rectum Cancer, Recurrent","Gastrointestinal Cancers - Liver","Anal Cancer","Anal Cancer Stage III","Anal Cancer Stage IV","Anal Cancer Recurrent","Anal Cancer Metastatic","Anal Cancer, Stage IIIA","Anal Cancer, Stage IIIB","Appendix Cancer","Ampullary Cancer","Bile Duct Cancer","Bile Duct Cancer Stage III","Bile Duct Cancer Stage IV","Bile Duct Cancer Stage IVA","Bile Duct Cancer Stage IVB","Bile Duct Cancer Recurrent","Carcinoid Tumor","Carcinoid Tumor of Pancreas","Carcinoid Tumor of Large Intestine","Carcinoid Tumor of GI System","Carcinoid Tumor of Colon","Carcinoid Tumor of Liver","Carcinoid Tumor of Cecum","Carcinoid Tumor of Ileum","Carcinoid Tumor of Rectum","Carcinoid Tumor of the Small Bowel","Carcinoid Tumor of the Stomach","Large Intestine Cancer","Esophagus Cancer","Esophagus Cancer, Stage III","Esophagus Cancer, Stage IV","Esophagus Cancer, Recurrent","Gallbladder Cancer","Gallbladder Cancer Stage III","Gallbladder Cancer Stage IV","Gastric (Stomach) Cancer","Neuroendocrine Tumor","Peritoneum Cancer","Rectal Cancer","Esophagus Cancer, Stage I","Esophagus Cancer, Stage II","Gallbladder Cancer Stage I","Gallbladder Cancer Stage II","Bile Duct Cancer Stage I","Bile Duct Cancer Stage II",[84,396,397,398,159],"VR","support","GI cancer","2026-02-18",{"date":401,"type":35},"2026-02-20",{"date":403,"type":35},"2021-10-05",{"date":405,"type":22},"2027-03-16",{"name":407,"class":42},"Cedars-Sinai Medical Center",{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":414,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":416,"enrollmentInfo":417,"targetDuration":4,"studyType":23,"phases":419,"briefSummary":420,"conditions":421,"keywords":424,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":436},"100624131","stereotactic-mri-guided-focused-ultrasound-mesencephalotomy-100624131","NCT07405645","Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy","Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy for Pain Palliation in Head, Neck, & Brachial Cancer","MRg-FUS","Inclusion Criteria:\n\n1. Men and women, between 18 and 85 years, inclusive\n2. Subjects with head, neck, or brachial cancer, including one of the following:\n\n   * Cancer that arises in the head and neck region: nasal cavity, sinuses, lips, mouth, salivary glands, throat, or larynx (typically squamous cell carcinoma)\n   * Cancer occurring in the nasopharynx, skin, thyroid gland, and eye\n   * Cancer involving the brachial region including brachial plexus, upper lung apex, and Pancoast tumors.\n   * Lymphoma\n   * Sarcoma\n3. Craniofacial, cervical, or brachial pain related to the cancer that meets all of the following criteria:\n\n   * Severe defined by: Worst NPRS score of ≥ 5 out of 10 at current visit and the subject reports having a similar level of pain for at least the past two months.\n   * Pain is medication-refractory to all three tiers of the WHO cancer pain ladder. Thus, adequate trials of at least 3 prescription medications that will include a 'weak' and a 'strong' opioid. An adequate medication trial is defined as a therapeutic dose of each medication without sufficient effect.\n   * Duration of greater than 3 months.\n4. Mesencephalon contralateral to the pain can be targeted by the ExAblate Neuro device. The region of the mesencephalon must be apparent on MRI. Additional MRI sequences including inversion-recovery and DTI may be utilized to refine the target.\n5. Subjects who are able and willing to give consent and able to attend all study visits\n6. Subjects who are able to communicate sensations during the focused ultrasound treatment\n\nExclusion Criteria:\n\n1. Idiopathic trigeminal neuralgia\n2. Trigeminal neuropathic pain from trauma, infection, or iatrogenic\n3. Post-herpetic neuralgia\n4. Headache syndromes like migraine, cluster headache\n5. Temporomandibular joint syndrome\n6. Atypical facial pain or pain related to a somatoform disorder\n7. Subjects deemed poor candidates by a multidisciplinary team of cancer and palliative care clinicians:\n\n   1. Subject deemed by their oncologist to have limited life expectancy for outcome assessment. At least 3 months life expectancy is required to obtain the primary efficacy outcome measure.\n   2. Significant clinician concern about reliability of subject-reported information, such as subject in active process of seeking disability for neuropathic pain\n   3. Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-V as manifested by one (or more) of the following occurring within a 12 month period: Recurrent substance use resulting in a failure to fulfill major role obligations at work, school, or home (such as repeated absences or poor work performance related to substance use; substance-related absences, suspensions, or expulsions from school; or neglect of children or household). Recurrent substance use in situations in which it is physically hazardous (such as driving an automobile or operating a machine when impaired by substance use)\n   4. Recurrent substance-related legal problems (such as arrests for substance related disorderly conduct)\n   5. Continued substance use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of the substance (for example, arguments with spouse about consequences of intoxication and physical fights).\n8. Subjects with active psychiatric illness will be excluded. For the purpose of this study, active psychiatric illness includes:\n\n   1. Exhibiting current suicide ideation and\u002For a history of suicide attempt within past 2 years\n   2. been hospitalized for the treatment of a psychiatric illness within the past 2 years\n   3. received transcranial magnetic stimulation for depression treatment\n   4. received electroconvulsive therapy for depression\n   5. any presence or history of psychosis\n9. Subjects with unstable cardiac status including:\n\n   1. Unstable angina pectoris on medication\n   2. Subjects with documented myocardial infarction within six months of protocol entry\n   3. Significant congestive heart failure defined with ejection fraction \\\u003C 40\n   4. Subjects with unstable ventricular arrhythmias\n   5. Subjects with atrial arrhythmias that are not rate-controlled\n10. Severe hypertension (diastolic BP \\> 100 on medication)\n11. Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.\n12. On medications that increases the bleeding risk, based on the published guidelines which are currently recognized by the American Society of Regional Anesthesia and Pain Medicine, American Academy of Pain Medicine and the North American Neuromodulation Society (Reg Anesth Pain Med 2015;40: 182-212); specifically:\n\n    1. Aspirin or another antiplatelet medication (clopidogrel, prasugrel, ticlopidine, abiciximab) for the last 7 days prior to treatment.\n    2. Oral, subcutaneous or intravenous anticoagulant medications, such as oral vitamin K inhibitors for the last 7 days, non-vitamin K inhibitor oral anticoagulant (dabigatran, apixaban, rivaroxaban) for the last 72 hours.\n    3. Intravenous or subcutaneous heparin-derived compounds for the last 48 hours.\n13. Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hours of total table time.)\n14. Subjects participating or have participated in another pain management clinical trial in the last 30 days\n15. Subjects with risk factors for intraoperative or postoperative bleeding from a documented coagulopathy or if their serum coagulation studies (platelet count, PT, PTT, and INR) exceed the institutional laboratory limits.\n16. Subjects with brain tumors or any significant intracranial mass that impedes the acoustic beam. Subjects with cerebral metastasis may be included if the lesion(s) do not affect the FUS treatment.\n17. Any illness that in the investigator's opinion preclude participation in this study\n18. Pregnancy or lactation\n19. Legal incapacity or limited legal capacity\n20. Subjects with a deep brain stimulation implant\n21. Skull density ratio, calculated from the baseline noncontrasted head CT, is less than 0.4\n22. History of hemorrhagic stroke or cerebrovascular event within the past year of treatment exhibiting incomplete resolution\n23. Subjects whose primary pain is other than craniofacial or brachial neuropathic pain.\n24. Patients deemed high risk because of their airway for the procedure as evaluated by anesthesia.","85 Years",{"count":418,"type":22},20,[25],"This phase 1 multi-site study investigates the safety and initial effectiveness of focused ultrasound lesioning of the contralateral mesencephalon for severe, opioid-resistant pain associated with head and neck cancer and brachial cancer.",[422,423,30],"Head Neck Cancer","Squamous Cell Cancer of Head and Neck (SCCHN)",[159,425,426],"mesencephalotomy","focused ultrasound","2026-02-04",{"date":429,"type":35},"2026-02-12",{"date":431,"type":22},"2026-02-15",{"date":433,"type":22},"2029-12-31",{"name":435,"class":42},"University of Virginia",6,{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":443,"eligibilityCriteria":444,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":288,"phases":4,"briefSummary":447,"conditions":448,"keywords":452,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":43},"100623701","mri-evaluation-of-spinal-cord-edema-after-ct-guided-percutaneous-cordotomy-in-cancer-pain-patients-100623701","NCT07400055","MRI Evaluation of Spinal Cord Edema After CT-Guided Percutaneous Cordotomy in Cancer Pain Patients","Evaluation of Medulla Spinalis Edema After CT-Guided Percutaneous Cervical Cordotomy Using Magnetic Resonance Imaging and Its Association With Postprocedural Clinical Outcomes in Patients With Cancer Pain","CORD-MRI","Inclusion Criteria:\n\nAdults aged 18 years and older\n\nPatients with cancer-related pain refractory to medical treatment\n\nPatients scheduled to undergo CT-guided percutaneous cervical cordotomy as part of routine clinical care\n\nAbility to provide informed consent\n\nAvailability for postoperative MRI follow-up on day 1 and at 1 month\n\nExclusion Criteria:\n\nPatients younger than 18 years\n\nPatients without an indication for percutaneous cervical cordotomy\n\nInability to undergo MRI (e.g., incompatible implants, severe claustrophobia)\n\nPatients who decline participation or withdraw consent\n\nIncomplete clinical or imaging follow-up data",{"count":446,"type":22},15,"This observational study aims to evaluate changes in the spinal cord following CT-guided percutaneous cervical cordotomy performed for the treatment of intractable cancer-related pain. Cordotomy is a routine clinical procedure used to relieve severe pain in selected cancer patients. After the procedure, some patients may develop temporary neurological symptoms that are thought to be related to spinal cord edema.\n\nIn this study, magnetic resonance imaging (MRI) will be performed as part of routine clinical follow-up on postoperative day 1 and at 1 month to assess the presence and extent of spinal cord edema. Clinical outcomes, including pain intensity and possible postprocedural symptoms, will be recorded and compared with MRI findings.\n\nThe goal of this research is to better understand the relationship between imaging changes in the spinal cord and clinical outcomes after cordotomy, which may help improve patient care and postoperative management in the future.",[30,449,450,451],"Intractable Pain","Spinal Cord Edema","Neuropathic Pain",[453,454,455,456,457,458],"Percutaneous Cordotomy","CT-guided Cordotomy","Cervical Cordotomy","Spinal Cord MRI","Radiofrequency Ablation","Postprocedural Complications","2026-02-03",{"date":300,"type":35},{"date":462,"type":22},"2026-03-01",{"date":464,"type":22},"2027-04-01",{"name":466,"class":42},"Mersin University",{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":23,"phases":476,"briefSummary":477,"conditions":478,"keywords":480,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":490,"leadSponsor":492,"locationsCount":43},"100623432","intermittent-erector-spinae-plane-block-via-subcutaneous-port-for-cancer-pain-100623432","NCT07396558","Intermittent Erector Spinae Plane Block Via Subcutaneous Port for Cancer Pain","Efficacy of Intermittent Erector Spinae Plane Block Via Subcutaneous Port for Cancer-Related Pain in Patients With Lung Cancer","Inclusion Criteria\n\n* Adult patients diagnosed with advanced-stage lung cancer who are currently receiving palliative care only.\n* Presence of chronic cancer-related chest pain lasting longer than 1 month, localized to the thoracic region due to chest wall invasion, pleural involvement, or bone metastases.\n* Performance status ≤ 3 according to the Eastern Cooperative Oncology Group (ECOG), allowing placement of a subcutaneous port and maintenance of local anesthetic administration.\n* Inadequate pain control with conventional analgesic therapies or clinical indication for the addition of regional analgesia.\n* Ability to understand the study procedures and provide written informed consent after receiving a full explanation of the intervention.\n\nExclusion Criteria:\n\n* Chest pain with radiation to the upper extremities, neck, or shoulder, suggestive of non-localized thoracic pain.\n* Severe hepatic or renal dysfunction, or severe heart failure (New York Heart Association class III-IV).\n* Local infection at the injection or port placement site, or uncontrolled systemic infection.\n* Severe cachexia or insufficient subcutaneous tissue that does not allow safe coverage of the subcutaneous port.\n* Known allergy to amide-type local anesthetics or other contraindications to regional anesthesia.\n* Severe cognitive impairment, altered consciousness, or inability to cooperate with post-intervention monitoring.\n* Lack of adequate caregiver support for home-based follow-up after discharge or inability to coordinate follow-up with local healthcare facilities.\n* Severe coagulation disorders, defined as:\n\n  * International normalized ratio (INR) \\> 1.5\n  * Activated partial thromboplastin time (aPTT) \\> 40 seconds\n  * Fibrinogen \\\u003C 1.5 g\u002FL\n  * Platelet count \\\u003C 50 × 10⁹\u002FL.",{"count":475,"type":22},180,[25],"Cancer-related pain is a common and challenging problem in patients with lung cancer, often requiring long-term pain management. Conventional pain treatments, including systemic medications, may not provide adequate relief or may cause significant side effects.\n\nThe erector spinae plane (ESP) block is a regional anesthesia technique that can help reduce pain by delivering local anesthetic near the nerves supplying the chest wall. This study aims to evaluate the effectiveness and safety of intermittent ESP block administered through a subcutaneous port for controlling cancer-related pain in patients with lung cancer.\n\nEligible patients with lung cancer and moderate to severe pain will receive intermittent ESP block injections via a subcutaneous port as part of their pain management plan. Pain intensity, analgesic requirements, and potential side effects will be assessed over time.\n\nThe results of this study may help determine whether intermittent ESP block via a subcutaneous port is a useful and feasible option for improving pain control and quality of life in patients with lung cancer.",[30,479],"Erector Spinae Plane Block",[479,481,482,483,484,485],"Regional Anesthesia","Cancer-Related Pain","Lung Cancer","Subcutaneous Port","Palliative Care","2026-02-01",{"date":488,"type":35},"2026-02-09",{"date":462,"type":22},{"date":491,"type":22},"2027-12-31",{"name":493,"class":42},"Hanoi Medical University",{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":499,"acronym":4,"eligibilityCriteria":500,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":284,"enrollmentInfo":501,"targetDuration":4,"studyType":23,"phases":503,"briefSummary":504,"conditions":505,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":507,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":43},"100622336","effect-of-adding-ultrasound-guided-ipack-block-to-adductor-canal-block-for-postoperative-pain-in-knee-tumor-excision-100622336","NCT07382297","Effect of Adding Ultrasound Guided IPACK Block to Adductor Canal Block for Postoperative Pain in Knee Tumor Excision","Analgesic Efficacy of Adding Ultra Sound Guided IPACK Block to Adductor Canal Block for Postoperative Pain Management After Excision of Tumors Around Knee: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* American Society of Anesthesiologists (ASA) physical status II-IV.\n* Patients undergoing excision of tumors around the knee under spinal anesthesia\n\nExclusion Criteria:\n\n* Patient refusal.\n* Neuromuscular disorders\n* Allergy to local anesthetics\n* Previous history of knee surgery\n* Patients with a prior knee infection\n* Contraindications to spinal anesthesia as coagulopathies and severe aortic stenosis.",{"count":502,"type":22},70,[25],"the aim of this study is to determine the analgesic effect of iPACK in combination to ACB after the excision of tumors around the Knee regarding the following:\n\n* Time to the 1st rescue analgesia.\n* Postoperative morphine consumption.\n* Postoperative visual analogue scale (VAS). This study will include patients, aged 18 to 65 years, belonging to the American Society of Anesthesiologists (ASA) physical status II to IV , undergoing excision of tumors around the knee under spinal anesthesia.\n\nPatients will be randomly allocated Group iPACK plus Adductor canal block (ACB) : patients will receive ACB plus iPACK block.\n\n• Control group : patients will not receive any block but will take morphine 3mg bolus at VAS more than 4 and regular NSAIDS and paracetamol iv.",[30],"2026-01-25",{"date":508,"type":35},"2026-02-02",{"date":510,"type":35},"2025-08-15",{"date":512,"type":22},"2026-06-30",{"name":514,"class":42},"National Cancer Institute, Egypt",{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":521,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":523,"targetDuration":4,"studyType":23,"phases":525,"briefSummary":526,"conditions":527,"keywords":529,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":94},"100617430","cognitive-behavioral-theory-assisted-virtual-reality-for-chronic-cancer-pain-vr-can-100617430","NCT07318519","Cognitive Behavioral Theory-assisted Virtual Reality for Chronic CANcer Pain (VR-CAN)","Cognitive Behavioral Theory-assisted Virtual Reality for Chronic Cancer Pain (VR-CAN): Device Prototype Development and Feasibility Testing","VR-CAN","Inclusion Criteria:\n\n* age at least 18 years old\n* cancer diagnosis, undergoing treatment\n* chronic cancer pain (i.e., cancer pain at least 3 months duration) with baseline pain severity at least 4\u002F10 (where 0=no pain, 10=worst pain)\n\nExclusion Criteria:\n\n* intractable nausea\u002Fvomiting, motion sickness, seizures\u002Fepilepsy, and\u002For cranial structures\u002Fabnormalities preventing VR headset use\n* moderate-severe pain of non-cancer etiology\n* enrolled in another pain study\n* unable to complete survey measures or interviews in English or Spanish",{"count":524,"type":22},40,[25],"While chronic cancer pain affecting as many as 75% of patients is typically addressed using pharmacologic interventions, experts and patients alike support maximizing any relevant non-pharmacologic interventions as well, such as cognitive behavioral therapy. Virtual reality, a novel technology that can temporarily immerse users in a calm, pleasant environment, has been increasingly shown to facilitate improvement in different acute and chronic pain syndromes by providing distraction from pain and lowering pain sensation. To address the significant needs of patients living with chronic cancer pain, we aim to develop and pilot test a prototype device that will leverage cognitive behavioral therapy principles to deliver a novel virtual reality pain therapy. The investigators will do this through the following steps:\n\nStep 1. Develop and refine a CBT-assisted VR prototype for patients with chronic cancer pain (VR-CAN).\n\nStep 2. Conduct a randomized controlled trial to examine the feasibility, acceptability, usability, safety, and initial clinical impact of the developed VR-CAN prototype compared to a tablet-based two-dimensional video control group.\n\nStep 3. Collect and evaluate qualitative post-intervention data on VR-CAN participants' preferences, thoughts, and feelings about the VR-CAN technology and protocol to optimize for a future, larger, fully powered randomized controlled trial.",[83,30,528],"Chronic Cancer Pain",[530,531,532,533,534],"cancer","pain","chronic pain","cognitive behavioral therapy","virtual reality","2026-01-02",{"date":537,"type":35},"2026-01-06",{"date":539,"type":35},"2025-07-01",{"date":541,"type":22},"2027-05-31",{"name":543,"class":42},"Medstar Health Research Institute",{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":288,"phases":4,"briefSummary":553,"conditions":554,"keywords":556,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":4},"100613354","udopal-study-home-based-interventional-approach-to-pain-management-in-home-hospitalized-patients-100613354","NCT07265492","UDOPAL Study: Home-Based Interventional Approach to Pain Management in Home-Hospitalized Patients","UDOPAL Study: Hospital-at-Home Interventional Approach to Pain Management in Patients Receiving Home-Based Hospital Care","UDOPAL","Inclusion Criteria:\n\n* Adult patients (≥18 years old) admitted to the Home Hospitalization Unit (UHD) of the Manises Health Department.\n* Presence of active pain, classified as mild, moderate, or severe.\n* Clinical assessment indicating suitability for interventional pain management, as determined by a UDOPAL-trained physician.\n* Physical and clinical conditions that allow the performance of interventional procedures at home under standardized safety precautions.\n* Signed informed consent obtained from the patient and\u002For a legally authorized representative in cases of incapacity.\n\nExclusion Criteria:\n\n* Very limited life expectancy (estimated survival \\\u003C72 hours) or terminal\u002Fagonal condition.\n* Contraindication to interventional pain procedures, including:\n\n  1. Uncorrectable coagulopathy.\n  2. Systemic infection or local infection at the puncture site.\n  3. Documented allergy to any of the planned medications.\n  4. Tumor located in the infiltration area.\n  5. Pregnancy or breastfeeding.\n* Altered level of consciousness or severe cognitive impairment without a responsible family member or without the possibility of obtaining valid informed consent.\n* Home environment conditions that do not ensure minimal hygiene, safety, or logistical support (e.g., inadequate lighting, lack of privacy, insufficient family assistance, or limited access for the medical team).\n* Explicit refusal by the patient and\u002For family to undergo interventional pain procedures.\n* Refusal to participate in the study.",{"count":103,"type":22},"The UDOPAL Study proposes an innovative home-based care approach for the management of pain in patients admitted to the Home Hospitalization Unit (UHD). This model incorporates interventional pain management techniques into the clinical practice of home-hospital professionals, supported when necessary by specialists from the Pain Medicine Unit.\n\nPain is a prevalent and often undertreated problem in patients receiving home hospitalization, where complex or oncologic pain may require specialized procedures that traditionally are only performed in hospital settings. The UDOPAL model aims to bridge this gap by providing ultrasound-guided and minimally invasive pain procedures directly at the patient's home, including nerve blocks, infiltrations, and other targeted interventions.\n\nThis observational, prospective study evaluates the feasibility, safety, and clinical impact of implementing interventional pain management at home. Adult patients with chronic, oncologic, or complex pain will be included. Outcomes include pain intensity, opioid use, functional improvement, quality of life, and patient satisfaction, as well as adverse events related to the techniques.\n\nThe study seeks to provide scientific evidence supporting a new model of interventional home-based pain care that improves comfort, continuity of care, and efficient use of healthcare resources. The project was approved by the Ethics Committee (CEIm Hospital Universitario y Politécnico La Fe, Acta No. 600, 08\u002F10\u002F2025) and is conducted at Hospital de Manises (Valencia, Spain).",[555,30,451,485],"Chronic Pain",[550,557,485,558,559,555,30,560,561,562,563,564,565,566,567,568,569,570],"Home Hospitalization","Palliative Pain Care","Nerve Blocks","Pain Relief","Opioid Reduction","Multidisciplinary Model","Hospital-at-Home","Home Health Care","Home Medical Services","Integrated Home Care","Hospital in the Home","Domiciliary Care","Home-Based Hospital Care","Interventional Pain Management","2025-11-24",{"date":573,"type":35},"2025-12-04",{"date":575,"type":22},"2025-12-01",{"date":577,"type":22},"2026-10-08",{"name":579,"class":42},"Hospital de Manises",{"id":581,"slug":582,"hasResults":12,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":586,"eligibilityCriteria":587,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":588,"targetDuration":4,"studyType":288,"phases":4,"briefSummary":589,"conditions":590,"keywords":593,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":94},"100418247","pain-assessment-in-cancer-patients-by-machine-learning-pascale-100418247","NCT04726228","Pain ASsessment in CAncer Patients by Machine LEarning (PASCALE)","Home-Based Telemedicine for Automatic Pain Assessment in Cancer Patients: Dataset Creation and Development of Machine Learning Algorithms","PASCALE","Inclusion Criteria:\n\n* Patients aged \\> 18 years\n* Home care patients diagnosed with advanced cancer disease and life expectancy ≤ 1 year\n* Patients receiving treatment for cancer pain\n* Patients who have given their consent\n\nExclusion Criteria:\n\n* Patients aged \\\u003C 18 years\n* Willingness to sign the informed consent form (unable to read or write)\n* Cognitive deficit (e.g. Alzheimer disease or senile dementia)",{"count":524,"type":22},"In cancer patients, the integration between anticancer therapies and palliative care is of fundamental importance. In this context, telemedicine can improve the quality of life (QoL) of chronic patients through self-management and remote monitoring solutions. This approach can favor the effectiveness of the treatment and therapeutic adherence. Of note, telemedicine can also be applied to the management of cancer pain. In the advanced stages of cancer disease, pain is one of the most obvious and most disabling symptoms. Consequently, proper pain management has a significant impact on the QoL, the ability to withstand treatment, and the recovery of patients. On the other hand, given the complexity of cancer pain, the main obstacle to its proper management is the lack of adequate measurement methods. Although in recent years a great deal of effort has been made in the direction of automatic pain assessment, both concerning the creation of datasets and the development of classification algorithms, the literature is lacking regarding the automatic measurement of pain in the setting of cancer patients. Observation by experienced clinical staff and self-assessment by patients could be useful for obtaining the ground truth and, in turn, for training automatic pain recognition systems.",[591,30,592],"Oncology","Quality of Life",[594,595,596,485,597,210,592],"Pain assessment","Machine Learning","Automatic Pain Assessment","Telemedicine","2025-07-24",{"date":600,"type":35},"2025-07-29",{"date":602,"type":35},"2021-06-21",{"date":604,"type":22},"2025-10",{"name":606,"class":42},"National Cancer Institute, Naples",{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":612,"acronym":4,"eligibilityCriteria":613,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":614,"targetDuration":4,"studyType":288,"phases":4,"briefSummary":616,"conditions":617,"keywords":620,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":624,"lastUpdatePostDateStruct":625,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":630,"locationsCount":43},"100503055","implementation-of-personalized-medicine-for-optimal-drug-therapy-in-cancer-100503055","NCT05830279","Implementation of Personalized Medicine for Optimal Drug Therapy in Cancer","Evaluating the Implementation of Personalized Medicine for Optimal Drug Therapy in Cancer Patients: A Prospective Longitudinal Trial","Inclusion Criteria:\n\n* Age 18 years or older\n* Prescribed a chemotherapy medication\n* Currently taking one or more study medications (citalopram, escitalopram, venlafaxine, desvenlafaxine, codeine, oxycodone, hydrocodone, tramadol or ondansetron)\n\nExclusion Criteria:\n\n* Patients who are unable to complete study materials (surveys) with or without assistance, including non-English speaking patients\n* Patients receiving palliative care\n* Patients taking anti-depressants for reason other than depression or anxiety, i.e. hot flash (Only applies to antidepressant cohort)\n* Patients with preexisting major depressive disorder prior to cancer diagnosis (Only applies to antidepressant cohort)",{"count":615,"type":22},600,"A prospective longitudinal cohort study that will assess the effect of a Personalized Medicine (PM) clinic recommendations on pharmacogenetic variation and\u002For interacting drugs on plasma drug exposure, effectiveness or toxicity of commonly used antidepressant, pain, and antiemetic medications in cancer patients. Such recommendations will entail genotype-guided treatment suggestions while also considering potential DDI, and will be provided to patients during their clinic visit, and referring physicians thereafter. Drug concentration and therapeutic effectiveness will be assessed before (baseline) and 6 months after recommendations have been provided. To assess effectiveness, patient-reported outcomes will be evaluated using validated scales for symptoms of depression, pain and chemotherapy-induced nausea\u002F vomiting\n\nThe investigators hypothesize that the pharmacogenetic variation and DDI, if applicable, determine steady state drug concentration and therapeutic response or toxicity of the investigated antidepressant, pain or antiemetic treatments at baseline, while there is a clinically significant reduction or absence of the effect 6 months after the PM clinic recommendations to referring physicians and patients.",[618,619,30],"Nausea With Vomiting Chemotherapy-Induced","Depression, Reactive",[621,622,623],"Personalized medicine","Pharmacogenetics","Therapeutic drug monitoring","2025-07-04",{"date":626,"type":35},"2025-07-09",{"date":628,"type":35},"2023-05-01",{"date":110,"type":22},{"name":631,"class":42},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's",{"id":633,"slug":634,"hasResults":12,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":638,"eligibilityCriteria":639,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":640,"targetDuration":4,"studyType":23,"phases":642,"briefSummary":643,"conditions":644,"keywords":645,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":648,"startDateStruct":650,"completionDateStruct":651,"leadSponsor":653,"locationsCount":43},"100597033","e-natureza-blue-care-nature-based-virtual-reality-and-pain-perception-100597033","NCT07053228","e-Natureza Blue Care: Nature-based Virtual Reality and Pain Perception","e-Natureza Blue Care - Impact of Virtual Reality on Pain Perception, Mood States, and Analgesic Use in Patients With Cancer Pain: Randomized Clinical Trial.","e-NatBlue","Inclusion Criteria:\n\n* hospitalized oncological patients with chronic pain.\n* both sexes\n* aged 18 years or older\n* preserved clinical condition and communication abilities that allow participation in the study\n* report pain documented in the electronic medical record\n\nExclusion Criteria:\n\n* Patients who are unable to tolerate wearing the virtual reality (VR) headset for at least 8 minutes\n* blind patients\n* patients who experience any side effects or worsening clinical condition during the interview\u002Fintervention period\n* patients undergoing other complementary treatments",{"count":641,"type":22},130,[25],"This randomized clinical trial aims to evaluate the effectiveness of immersive nature-based virtual reality in managing chronic pain among oncology patients. The study seeks to expand non-pharmacological treatment options and contribute to the therapeutic arsenal available for chronic pain management in cancer care.The intervention utilizes immersive videos of diverse Brazilian natural environments to promote analgesic and emotional relief.",[30,485],[30,646,647],"Palliative care","Virtual reality",{"date":649,"type":35},"2025-07-08",{"date":510,"type":22},{"date":652,"type":22},"2026-03-30",{"name":654,"class":42},"Hospital Israelita Albert Einstein",{"id":656,"slug":657,"hasResults":12,"nctId":658,"briefTitle":659,"officialTitle":659,"acronym":660,"eligibilityCriteria":661,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":662,"targetDuration":4,"studyType":23,"phases":664,"briefSummary":665,"conditions":666,"keywords":668,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":675,"lastUpdatePostDateStruct":676,"startDateStruct":678,"completionDateStruct":680,"leadSponsor":682,"locationsCount":43},"100595898","refining-multiple-artificial-intelligence-strategies-for-automatic-pain-assessment-investigations-ruggi-study-100595898","NCT07038434","Refining mUltiple Artificial intelliGence strateGies for Automatic Pain Assessment Investigations: RUGGI Study","RUGGI","Inclusion Criteria:\n\n* Adults (≥18 years old) with chronic pain, defined according to IASP and ICD-11 as pain that persists or recurs for more than three months.\n* Diagnosed with either:\n* Chronic primary pain (e.g., fibromyalgia, irritable bowel syndrome, chronic headaches)\n* Chronic secondary non-cancer pain (e.g., low back pain, osteoarthritis, post-surgical pain)\n* Chronic cancer-related pain (due to cancer or its treatment)\n* Ability to understand the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Current treatment with psychotropic drugs or presence of active psychiatric disorders (e.g., psychosis, major depression).\n* Known history of alcohol or substance abuse.\n* Pregnancy or breastfeeding.\n* Age under 18 years.\n* Inability to provide informed consent (e.g., due to cognitive impairment).",{"count":663,"type":22},200,[25],"This single-center, non-profit, observational-interventional study aims to develop artificial intelligence (AI) models for the automatic assessment of chronic pain (APA - Automatic Pain Assessment). The study will enroll adult patients with chronic pain of various origins (oncologic and non-oncologic). Participants will undergo multidimensional evaluations that include clinical assessments, self-report questionnaires, bio-signal collection (e.g., EEG, EDA, HRV, GSR, PPG), and facial expression analysis via infrared thermography and video recordings.\n\nThe primary objective is to calibrate and test machine learning and deep learning models to recognize and predict the presence and severity of pain using multimodal data inputs. Secondary objectives include evaluating the effectiveness of pain treatments, assessing quality of life, and developing a standardized APA dataset for future research.\n\nAll data collection procedures are non-invasive and safe, and include tools like wearable sensors and standardized neurocognitive tests. The study is approved by the Italian Ethics Committee (Comitato Etico Territoriale Campania 2) and complies with GDPR and EU AI regulations.",[555,30,451,667],"Pain Assessment",[669,595,670,596,671,672,673,674,555],"Artificial Intelligence","Deep Learning","Facial Expression Analysis","Natural Language Processing","Stroop Test","Bio-signals","2025-06-17",{"date":677,"type":35},"2025-06-26",{"date":679,"type":35},"2025-05-06",{"date":681,"type":22},"2026-01",{"name":683,"class":42},"Valentina Cerrone",{"id":685,"slug":686,"hasResults":12,"nctId":687,"briefTitle":688,"officialTitle":689,"acronym":690,"eligibilityCriteria":691,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":692,"targetDuration":4,"studyType":23,"phases":694,"briefSummary":695,"conditions":696,"keywords":703,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":713,"lastUpdatePostDateStruct":714,"startDateStruct":716,"completionDateStruct":717,"leadSponsor":718,"locationsCount":43},"100591303","neurolytic-block-techniques-in-abdominal-visceral-cancer-pain-100591303","NCT06978673","Neurolytic Block Techniques In Abdominal Visceral Cancer Pain","Comparison of Neurolytic Block Techniques for the Treatment of Abdominal Visceral Pain and Their Influence On The Quality of Life of Patients With Cancer","CONCERN","Inclusion Criteria:\n\nPatients aged 18 years or older Presence of localized visceral pain in the upper abdomen originating from cancer of the stomach, duodenum, distal esophagus, ascending or transverse colon, liver, biliary tract, or pancreas\n\nIneffectiveness of analgesic treatment with third-step opioids according to the WHO analgesic ladder, including:\n\nOpioids (≥ 60 mg\u002Fday of morphine equivalents) Antidepressants (tricyclic or dual-action), at any dosage Gabapentinoids, at any dosage Presence of side effects from analgesics that are difficult to manage with medication\n\nExclusion Criteria:\n\nPresence of ascites Presence of deep vein thrombosis Presence of hepatic failure: Child-Pugh class B or C Presence of renal failure: estimated glomerular filtration rate (eGFR) \\\u003C 60 ml\u002Fmin\u002F1.73 m² Use of any anticoagulant medication\n\nClinical coagulation disorder, defined as:\n\nINR \\> 1.5 Prothrombin activity \\\u003C 70% or prothrombin time \\> 13.5 seconds aPTT \\> 40 seconds Cardiovascular failure: NYHA class III",{"count":693,"type":22},64,[25],"The neurolytic blocks of sympathetic chains are commonly used for the treatment of cancer-related pain. This study aims to compare celiac plexus neurolysis and splanchnic nerve neurolysis for the treatment of abdominal visceral pain and its influence on the quality of life of patients with cancer.",[697,698,30,317,699,700,701,702],"Cancer, Malignant Tumors","Abdominal Cancer","Cancer-related Pain","Pain Management","Celiac Ganglia","Sympathetic Ganglia",[159,704,705,530,706,707,708,709,710,711,712],"visceral pain","abdominal cancer","abdominal pain","cancer-related pain","pain management","neurolytic block","splanchnic nerve block","celiac plexus block","sympathetic neurolysis","2025-05-30",{"date":715,"type":35},"2025-06-03",{"date":713,"type":22},{"date":214,"type":22},{"name":719,"class":42},"Instituto do Cancer do Estado de São Paulo",{"id":721,"slug":722,"hasResults":12,"nctId":723,"briefTitle":724,"officialTitle":725,"acronym":4,"eligibilityCriteria":726,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":727,"targetDuration":4,"studyType":23,"phases":729,"briefSummary":730,"conditions":731,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":732,"lastUpdatePostDateStruct":733,"startDateStruct":735,"completionDateStruct":737,"leadSponsor":739,"locationsCount":43},"100593612","phase-1-phase-i-study-of-sss40-injection-for-moderate-to-severe-bone-metastatic-cancer-pain-100593612","NCT07008703","Phase I Study of sss40 Injection for Moderate-to-Severe Bone Metastatic Cancer Pain","Phase Ib\u002FIIa Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetic Characteristics of SSS40 in Subjects With Moderate to Severe Bone Metastasis Cancer Pain","Inclusion Criteria:\n\n1. The subjects voluntarily sign an informed consent form, voluntarily participate in the trial, and are willing and able to receive medication, examination, visits, and other related operations according to the trial protocol;\n2. When signing the informed consent form, adult male or female subjects aged ≥ 18 years old；\n3. Previous medical records confirm that the subject has cancer and is diagnosed with bone metastasis; During screening or within 120 days prior to screening visits, Confirming bone metastasis through imaging according to local medical standards, such as bone scans, magnetic resonance imaging (MRI), computed tomography (CT) scans, or positron emission computed tomography (PET-CT) Scanning, diagnosed as bone metastasis based on CT\u002FMRI\u002FPET-CT. If the above examination is not performed within 120 days, a bone scan confirmation is required. If imaging only involves bone scanning, additional CT, MRI, or PET is required to confirm bone metastasis；\n4. Weight ≥ 40kg during screening；\n5. Expected survival time ≥ 3 months；\n6. Pain at the site of cancer bone metastasis, with an average pain score of ≥ 4 points at the designated pain point of bone metastasis (screening period and baseline evaluation period of 3 days)；\n7. When screening, the Eastern Oncology Collaborative Group (ECOG) physical condition score was ≤ 2 points；\n8. The subjects are willing not to use prohibited drugs throughout the entire study period；\n9. The subjects are willing to refrain from using chemotherapy drugs with significant bone marrow suppression from 14 days before administration to 28 days after administration. Among them, drugs with significant bone marrow suppression include paclitaxel (PTX), docetaxel (TXT), vinorelbine (NVB), tiniposide (VM-26), vindesin (VDS), etoposide (VP-16), carboplatin (CBP), mitoxantrone (MITX), nitrogen mustard (HN2), daunorubicin (DNR), and doxorubicin (ADM) \\[THP, MTX, 6-MP, and IFO\\]；\n10. During screening, the bone marrow function of the subjects meets the following requirements (if necessary, can be repeated for confirmation): a. Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3 or ≥ 1.5 × 109\u002FL; b. Platelet count ≥ 90000\u002Fmm3 or ≥ 90 × 109\u002FL; c. Hemoglobin ≥ 70.0 g\u002FL；\n11. When screening, the renal function meets the following requirements (if necessary, repeat the examination to confirm): a Estimated glomerular filtration rate ≥ 30 mL\u002Fmin, and b. Urinary protein\\\u003C2+；\n12. During screening, liver function meets the following requirements (if necessary, can be repeated for confirmation): a. Total serum bilirubin ≤ 1.5 × ULN; b. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5.0 if the tumor affects the liver) × ULN; c. Alkaline phosphatase ≤ 5 × ULN；\n13. If the subject is not currently receiving anticoagulant therapy, the international standardized ratio (INR) or prothrombin time (PT) during screening should be less than 1.5 × ULN (can be double checked to confirm if necessary). Subjects currently receiving anticoagulant therapy must have an INR within the recommended range applicable to their clinical status；\n14. Female participants of childbearing age must agree to use reliable contraceptive measures within 6 months after the start of the study medication and have no plans to conceive or donate eggs; Male participants must agree to use reliable contraceptive measures within 6 months of starting the study medication and have no plans for childbirth or sperm donation；\n15. The subjects are able to communicate well with the researchers and complete the study in accordance with the research regulations.\n\nExclusion Criteria:\n\n1. During screening, there was hypercalcemia (blood calcium concentration ≥ 2.75mmol\u002FL or 11.0mg\u002FdL)；\n2. The pain of the subjects is caused by reasons unrelated to cancer bone metastasis (such as intestinal obstruction\u002Fperforation, spinal cord compression, brain metastasis, pathological fractures or near fractures, etc.)；\n3. The pain of the subjects is neuropathic pain, visceral pain, or unknown in nature, caused by previous anti-tumor treatment, infection, or other reasons mainly unrelated to bone metastasis；\n4. Subjects with brain or meningeal metastases (patients with stable brain metastases can be included in this study)；\n5. Starting systemic treatment for primary malignant tumors or bone metastases within 14 days prior to the first day of the baseline assessment period, including chemotherapy and hormone therapy (excluding those who have received stable treatment for at least 30 days prior to the first day of the baseline assessment period and still meet the inclusion criteria for bone pain severity)；\n6. Individuals who have developed peripheral neuropathy and unstable neuropathy after receiving radiation therapy for bone metastases within 30 days prior to the first day of the baseline evaluation period；\n7. Individuals who receive unstable radiation therapy within 30 days prior to the first day of the baseline evaluation period or experience a significant decrease in NRS score (by more than 3 points) after radiation therapy；\n8. Starting within 30 days prior to the baseline evaluation period, unstable doses of adjuvant analgesic therapy (such as unstable doses combined with single agent acetaminophen (paracetamol), serotonin\u002Fnorepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, antiepileptics, bisphosphonates, desukumab, corticosteroids or muscle relaxants, etc.) should be used；\n9. Diagnosed as knee or hip arthritis or Kellgren Lawrence grade ≥ 2 according to the American Rheumatology Association (ACR) and clinical and imaging standards；\n10. Screening for major injuries or surgeries in major joints (such as hip, knee, or shoulder) within the previous year; Individuals with a history of osteonecrosis or osteoporotic fractures (i.e., subjects with osteoporosis and mild traumatic or non traumatic fractures) or a history of joint related events, such as meniscus or knee ligament injuries (with or without surgical repair) or joint infections；\n11. Imaging atlas, determined by researchers, with imaging evidence indicating any of the following diseases during screening: a) rapidly progressive osteoarthritis, b) atrophic or malnourished osteoarthritis, c) subchondral incomplete fractures, d) spontaneous knee joint osteonecrosis (SPONK), e) osteonecrosis, f) pathological fractures, g) neuroarthritis (Charcot's joint), h) crystalline arthritis, i) rheumatoid arthritis, j) lupus erythematosus, k) Significant knee joint effusion or active infection, l) shoulder osteoarthritis and other diseases. Note: i. Patients with bone necrosis secondary to radiotherapy (i.e. radiation-induced osteonecrosis) and related to bone metastasis (i.e. involving the tumor bone interface) are allowed to participate in this study. Ii. Subjects with pathological vertebral fractures with vertebral body damage less than 50% and no spinal canal damage are allowed to participate in this study. Iii. Subjects with pathological fractures of non weight-bearing bone (such as humerus) that have been treated (such as fixation) and have healed, if the fracture does not involve the large joint, can participate in this study；\n12. Individuals with a clinically significant history of heart disease, including those classified by the New York Heart Association as grade III or IV congestive heart failure, left ventricular insufficiency ejection fraction\\\u003C35%, ischemic heart disease, surgical treatment for coronary artery disease, and significantly abnormal electrocardiograms (resting tachycardia (heart rate ≥ 120 beats\u002Fmin) or resting bradycardia (heart rate ≤ 45 beats\u002Fmin) within the first 6 months of screening；\n13. Diagnosed as transient ischemic attack or stroke with sequelae (such as aphasia, significant motor or sensory dysfunction) within the first 6 months of screening；\n14. A clinically significant history, diagnosis, or symptoms and signs of neurological diseases, including but not limited to: a Alzheimer's disease or other types of dementia; b. Head trauma with clinical significance within the past year; c. Peripheral neuropathy or autonomic neuropathy (including chemotherapy related peripheral neuropathy); d. Epilepsy or epilepsy related diseases, with a history of epileptic seizures within 2 years prior to screening; e. Myopathy；\n15. Individuals with an overall impact score greater than 7 on the Autonomous Neurological Symptom Survey (SAS) during screening；\n16. Individuals with a history of carpal tunnel syndrome (CTS) and experiencing symptoms or signs of CTS within the year prior to screening；\n17. Individuals with a history of allergic reactions or rapid allergic reactions to therapeutic or diagnostic monoclonal antibodies or IgG fusion proteins；\n18. Positive cases of active hepatitis, HIV infection, and Treponema pallidum infection were found during screening；\n19. Vaccination received one month before screening；\n20. Screening for individuals with a significant history of alcohol abuse, abuse of analgesics or anesthetics within the first 6 months (excluding medications currently under treatment)；\n21. Previous exposure to exogenous nerve growth factor or anti nerve growth factor antibodies；\n22. Participate in other clinical studies within 30 days prior to the baseline evaluation period (90 days for investigational biologics)；\n23. The presence of severe acute or chronic diseases, mental disorders, or laboratory test abnormalities may increase the risk of subjects participating in this study or receiving treatment with study drugs, or may affect the interpretation of the research results. According to the judgment of the researchers, these conditions may make the subjects unsuitable to participate in this study.",{"count":728,"type":22},132,[229,206],"This is a Phase Ib\u002FIIa, multicenter, sequential clinical trial evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of SSS40 injection in patients with moderate-to-severe bone metastatic cancer pain. The study includes two stages: a single-arm, open-label, dose-escalation and dose-expansion Phase Ib followed by a randomized, double-blind, placebo-controlled Phase IIa.",[30],"2025-05-29",{"date":734,"type":35},"2025-06-06",{"date":736,"type":35},"2024-03-27",{"date":738,"type":22},"2025-12",{"name":740,"class":218},"Shenyang Sunshine Pharmaceutical Co., LTD.",{"id":742,"slug":743,"hasResults":12,"nctId":744,"briefTitle":745,"officialTitle":745,"acronym":746,"eligibilityCriteria":747,"healthyVolunteers":174,"sex":52,"minAge":19,"maxAge":284,"enrollmentInfo":748,"targetDuration":4,"studyType":23,"phases":749,"briefSummary":750,"conditions":751,"keywords":787,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":808,"lastUpdatePostDateStruct":809,"startDateStruct":811,"completionDateStruct":813,"leadSponsor":815,"locationsCount":43},"100565622","phase-1-evaluating-the-efficacy-and-safety-of-prosomnia-sleep-therapy-in-patients-with-sleep-deprivation-and-chronic-insomnia-100565622","NCT06644573","Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic Insomnia","PSHW","By adhering to the following criteria, the study aims to select a population that can safely undergo the PROSOMNIA Sleep therapy and for whom the therapy is most likely to be beneficial, ensuring the reliability and validity of the study outcomes.\n\nINCLUSION CRITERIA:\n\n1. Age Range: 18-65 years of age Reason: This age range includes adults who are most likely to benefit from the PROSOMNIA Sleep therapy and who can provide informed consent. It also excludes children and older adults who may have different physiological responses or additional health risks.\n2. Diagnosed or Undiagnosed Chronic Insomnia:\n\n   Reason: Included subjects have a consistent pattern of sleep disturbances that PROSOMNIA Sleep Therapy aims to treat.\n3. Diagnosed or Undiagnosed Sleep Deprivation:\n\n   Reason: Includes individuals who are not getting enough sleep quantity, which is a key condition that the PROSOMNIA Sleep Therapy aims to address.\n4. Diagnosed or Undiagnosed REM Sleep Inconsistencies:\n\n   Reason: Includes individuals who are not getting enough sleep quality and those with specific REM sleep phase issues that the PROSOMNIA Sleep Therapy is designed to improve.\n5. Failure to Respond to Conventional Sleep Treatments:\n\n   Reason: Focuses on subjects who have not found relief from existing sleep therapies, ensuring that the study population represents those in need of alternative solutions.\n6. Ability to Provide Informed Consent:\n\nReason: Ensures that participants understand the study and agree to participate voluntarily.\n\nEXCLUSION CRITERIA:\n\n1. Severe Obesity (BMI \\> 40):\n\n   Reason: Severe obesity can increase the risk of complications with anesthesia and may affect sleep patterns in ways that could confound study results.\n2. Cardiovascular Conditions:\n\n   Reason: Patients with significant heart conditions are at higher risk for complications during anesthesia.\n3. Neurological Disorders:\n\n   Reason: These diagnosed conditions and medications such as epilepsy could interfere with sleep patterns and responses to sleep therapy.\n4. Other Health Conditions Contraindicating Anesthesia:\n\n   Reason: Includes any condition that would make the use of anesthesia unsafe.\n5. Greater than ASA II Status:\n\n   Reason: The American Society of Anesthesiologists (ASA) physical status classification system classifies patients based on their pre-anesthesia medical conditions. Excluding those above ASA II ensures that only patients with mild systemic disease are included, to minimize risks.\n6. Current Use of Prohibited Medications:\n\n   Reason: Medications that could interfere with the combined use of anesthesia including, but not limited to sedatives and hypnotics; such as benzodiazepines, Z-drugs and barbiturates.\n7. Pregnancy or Breastfeeding:\n\nReason: Ensures the safety of the fetus or infant, as the effects of the PROSOMNIA Sleep therapy on pregnancy or lactation are unknown.",{"count":103,"type":22},[229],"This clinical trial aims to evaluate the safety and efficacy of PROSOMNIA Sleep Therapy (PSTx) for individuals suffering from chronic insomnia, sleep deprivation, and REM sleep disorders. Chronic insomnia, characterized by difficulty falling or staying asleep, significantly affects patients and quality of life, mood, and cognitive function. REM sleep disorders, in which the body struggles to enter or maintain restful REM sleep, can worsen these issues. The trial introduces a novel therapy using anesthesia-induced sleep, targeting sleep homeostasis and improving sleep architecture.\n\nObjectives: The primary goals of the trial are to determine:\n\n1. Whether PROSOMNIA Sleep Therapy increases the quality of REM sleep.\n2. Whether PSTx increases the duration of REM and\u002For NREM sleep.\n3. Whether PSTx decreases the time it takes participants to fall asleep (sleep onset latency).\n\nParticipants will receive ONE (1) PROSOMNIA Sleep Therapy session lasting between 60-120 minutes. Each session uses Diprivan\u002FPropofol to induce sleep, and is monitored via an EEG to ensure proper sleep stages, particularly REM sleep.\n\nParticipant Criteria:\n\nInclusion: Adults aged 18-65 with diagnosed or undiagnosed chronic insomnia or sleep deprivation.\n\nExclusion: Patients with severe obesity, significant cardiovascular, neurological, or psychiatric conditions, or those with an ASA status above II.\n\nStudy Design: This trial is non-randomized, single-arm and open-label, with all participants receiving the PSTx. The trial does not include a comparison group, as the focus is on evaluating the immediate, direct effects of the therapy.\n\nParticipants will undergo continuous EEG monitoring during therapy sessions, allowing researchers to track brain activity and sleep stages in real-time. This method ensures that sleep cycles, particularly REM sleep, are optimized for therapeutic benefit.\n\nTherapy Methodology:\n\nPROSOMNIA Sleep Therapy leverages anesthesia to mimic natural sleep patterns and enhance the efficiency of REM sleep. Diprivan\u002FPropofol is used to induce REM sleep, while EEG monitoring tracks and maintains proper sleep architecture throughout the session. The therapy promotes the clearance of adenosine, a compound that builds up during wakefulness and drives the need for sleep. Adenosine is cleared during REM sleep, reducing sleep pressure and improving cognitive function.\n\nOutcome Measures:\n\nPrimary Outcomes: Researchers will measure the increase in REM sleep duration, improvement in sleep quality (via self-reported questionnaires), and a reduction in sleep onset latency.\n\nSecondary Outcomes: These include changes in mood, cognitive function, and blood serum uric acid levels. Patient-reported outcomes will also be tracked through tools like the PROSOMNIA Sleep Quiz, which is specifically designed for PSTx.\n\nSignificance: Chronic insomnia and REM sleep disorders affect millions globally, leading to cognitive impairment, mood disturbances, and poor overall health. Traditional treatments, including pharmacological approaches and Cognitive Behavioral Therapy for Insomnia (CBT-I), often provide suboptimal results for many individuals. PSTx offers a novel, therapeutic approach to restoring sleep balance and enhancing the overall quality of sleep, particularly for those who have not responded to conventional treatments.\n\nStudy Process:\n\nRecruitment and Baseline Assessments: Participants undergo a comprehensive sleep assessment, including sleep questionnaires and polysomnography, to establish a baseline for sleep quality and duration. Blood serum uric acid levels will also be measured to track any biochemical changes due to therapy.\n\nTherapy Sessions: Only one (1) PROSOMNIA Sleep Therapy session will be administered, with the session lasting between 60-120 minutes. Diprivan\u002FPropofol is used to induce sleep, and EEG will monitor brain activity to ensure the proper balance of sleep stages.\n\nPost-Therapy Follow-up: Follow-up assessments will occur at 24 hours, 7 days, and 30 days post-treatment. Researchers will analyze the therapy effects on REM sleep, mood, cognitive function, and other health indicators.\n\nPotential Implications: If successful, this trial could revolutionize how we treat sleep disorders by targeting the underlying mechanisms of sleep pressure and REM sleep disruption. PROSOMNIA Sleep Therapy may offer a safe, effective, and immediate alternative for patients who have exhausted other treatment options.\n\nKey Concepts:\n\nHomeostatic sleep drive, (Process S), caused by adenosine buildup during wakefulness, is disrupted by chronic insomnia. This impacts cognitive function health and recovery. Anesthesia-induced REM sleep via PSTx helps regulate this homeostatic sleep stage, offering deeper and more restorative sleep compared to other sleep therapies. The study uses statistical methods like ANOVA and Chi-square to measure outcomes.",[752,753,754,755,756,757,758,759,760,761,762,763,764,765,766,767,768,769,770,771,772,773,774,775,776,777,778,779,780,781,782,783,784,785,237,30,786],"Chronic Insomnia","Sleep Deprivation","REM Behavior Disorder","REM Sleep Behavior Disorder","REM Sleep Measurement","Insomnia","Insomnia Related to Specified Disorder","Insomnia Due to Other Mental Disorder","Insomnia Comorbid to Psychiatric Disorder","Insomnia Due to Anxiety and Fear","Insomnia Related to Another Mental Condition","Insomnia Disorders","Idiopathic Hypersomnia","Sleep Disorders, Circadian Rhythm","Post Trauma Nightmares","PTSD - Post Traumatic Stress Disorder","Sleep Quality","Anesthesia","Anxiety","Depression","Mental Health","Alzheimer Disease or Associated Disorder","Parkinsons","Circadian Rhythm","Circadian Dysregulation","PTSD","Post-Traumatic","Post-Traumatic Stress Disorder Complex","Military Combat Stress Reaction","Sleep","Military Activity","Veterans","Shift Work Sleep Disorder","Menopause Related Conditions","Athletes",[788,789,790,791,792,793,794,795,796,797,798,799,800,801,802,803,804,805,757,753,806,764,807,777,772,770,771],"SLEEP","PROSOMNIA Sleep","PROSOMNIA Sleep Therapy","PSTx","PROSOMNIA","Anesthesia Sleep","REM Sleep","REM Sleep Therapy","PROSOMNIA Sleep Health","PROSOMNIA Sleep Wellness","PROSOMNIA Sleep Treatment","Nyree","Nyree Penn","Propofol","Propofol Sleep","Diprivan","Diprivan Sleep","PROSOMNIA Sleep Health and Wellness","IH","Sleep Debt","2025-05-27",{"date":810,"type":35},"2025-05-28",{"date":812,"type":22},"2025-11-01",{"date":814,"type":22},"2026-05-01",{"name":800,"class":218}]