[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fatigue-related-to-cancer-treatment\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fatigue-related-to-cancer-treatment":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,47,66,98,130,167],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100644031","phase-3-nuvastatic-phase-iii-trial-for-fatigue-in-triple-negative-breast-cancer-100644031",false,"NCT07669467","Nuvastatic® Phase III Trial for Fatigue in Triple-Negative Breast Cancer","A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Nuvastatic® 300 mg Capsules in Reducing Chemotherapy-Induced Fatigue in Patients With Metastatic Triple-Negative Breast Cancer Receiving Standard Chemotherapy","NuvastaticTM","Inclusion Criteria:\n\n* Female patients aged ≥ 18 years and ≤ 65 years who are willing to voluntarily provide consent for participation in the study.\n* Patients with confirmed triple negative metastatic breast cancer who are planned or scheduled to receive standard chemotherapy treatment for at least 4 to 6 cycles respectively.\n* Patients must have a confirmed diagnosis of triple negative metastatic breast cancer as per standard guidelines.\n* Patients must have at least one tumour lesion with ≥ 1cm in one dimension that is radiographically apparent on computed tomography (CT) or magnetic resonance imaging (MRI).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at screening.\n* The patient has stable haemoglobin (≥ 9 g\u002FdL) throughout the screening.\n* Life expectancy ≥ 6 months, as per the investigator's judgment.\n* Patients with co-morbidities or medical conditions including Type 2 diabetes mellitus (DM) and hypertension who are deemed stable by the investigator can be included in the study.\n* At screening, patients with stable fatigue, newly developed fatigue, or worsening fatigue scores as assessed by the Brief Fatigue Inventory (BFI) should be included.\n\nExclusion Criteria:\n\n* Patients who have any untreated reversible medical condition which may cause fatigue (e.g. major metabolic or electrolyte disturbance, active infection, endocrine abnormalities) as per the investigator's clinical judgment.\n* Patients with an inability to understand local language(s) for scales used for evaluations i.e. VAFS, BFI AND SF-36.\n* Patients who have received concurrent stimulant medication (e.g. dextroamphetamine or methylphenidate) during the screening period or any medication which may interfere with the study drug.\n* Patients with any delay in chemotherapy treatment such that the screening period extends beyond 21 days.\n* Patients with known central nervous system (CNS) involvement.\n* Patients with any serious, uncontrolled, non-malignant medical or psychiatric disorder, or any other medical condition which in the opinion of the investigator, may affect the patient's safety or study participation and conduct.\n* Female patients who are pregnant or breastfeeding.\n* Patients with known hepatitis C virus, hepatitis B virus, HIV infection.\n* Patients who have nausea and vomiting or any gastrointestinal disorder that is severe enough to interfere with study drug absorption in the opinion of the investigator.\n* Patients with uncontrolled pain, who in the opinion of the investigator are not eligible for the study.\n* Patients with known hypersensitivity or intolerance of rosmarinic acid, caffeic acid, and other related phenolic compounds as well as excipients in the Nuvastatic® 300 mg or placebo treatment.\n* Patients with planned therapy or treatment with another investigational agent.\n* Previous exposure to any investigational agent within 4 weeks prior to screening, or planned administration of an investigational agent, other than as specified by this protocol, during the study period.","FEMALE","18 Years","65 Years",{"count":21,"type":22},250,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The goal of this clinical trial is to evaluate whether Nuvastatic 300 mg capsules can reduce cancer-related fatigue in adult patients with colon cancer undergoing first-line chemotherapy.\n\nThe main questions it aims to answer are:\n\n* Does Nuvastatic 300 mg capsules significantly reduce cancer-related fatigue compared to placebo?\n* Is Nuvastatic 300 mg capsules safe and well tolerated in this patient population?\n\nResearchers will compare Nuvastatic 300 mg capsules vs placebo to see if Nuvastatic 300 capsule improves fatigue scores and maintains an acceptable safety profile.\n\nParticipants will:\n\n* Receive Nuvastatic 300 mg capsules or placebo capsules (3 times per day) for 3 cycles of 20 days each (total \\~60 treatment days).\n* Continue their standard first-line chemotherapy regimen.\n* Provide blood sample assessments at Screening and End of Treatment.\n* Complete patient diaries and fatigue assessments as per protocol.",[28,29],"Fatigue Related to Cancer Treatment","Breast Cancer",[31,29,32,33,34],"Nuvastatic","Cancer related fatigue","Randomized double blind placebo controlled trail","First-Line Chemotherapy","RECRUITING","2026-06-22",{"date":38,"type":39},"2026-06-25","ACTUAL",{"date":41,"type":39},"2025-10-01",{"date":43,"type":22},"2026-10-30",{"name":45,"class":46},"Natureceuticals Sdn Bhd","INDUSTRY",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":15,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":53,"minAge":18,"maxAge":19,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":63,"leadSponsor":65,"locationsCount":5},"100643923","phase-3-a-randomized-double-blind-placebo-controlled-parallel-group-comparative-phase-iii-study-to-evaluate-the-efficacy-and-safety-of-nuvastatic-300mg-capsule-in-reducing-cancer-tumor-in-patients-with-metastatic-colorectal-cancer-receiving-standard-chemotherapy-100643923","NCT07669454","A Randomized, Double-blind, Placebo-controlled, Parallel-group, Comparative, Phase III Study to Evaluate the Efficacy and Safety of Nuvastatic® 300mg Capsule in Reducing Cancer-Tumor in Patients With Metastatic Colorectal Cancer Receiving Standard Chemotherapy.","Inclusion Criteria:\n\n* Male and female patients who are ≥18 and ≤65 years of age, who are willing to voluntarily provide consent for participation in the study.\n* Patients with metastatic colorectal cancer planned or scheduled to receive standard chemotherapy treatment for at least 6 cycles respectively.\n* Patients must have a confirmed diagnosis of metastatic colorectal cancer as per standard guidelines.\n* Patients must have at least one tumor lesion with ≥ 1cm in one dimension that is radiographically apparent on computed tomography (CT) or magnetic resonance imaging (MRI).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening.\n* Life expectancy ≥ 6 months, as per investigator's judgment.\n* The patient has stable hemoglobin (≥ 9 g\u002FdL)throughout the screening.\n* Patients with co-morbidities or medical conditions including Type 2 diabetes mellitus (DM), hypertension who are deemed stable by the investigator can be included in the study.\n\nExclusion Criteria:\n\n* Patients who have any untreated reversible medical condition which may cause fatigue (e.g. metabolic disturbance, infection, endocrine abnormalities) as per the investigator's clinical judgment.\n* Patients with an inability to understand local language(s) for scales used for evaluations, i.e., EORTC QLQ-C30, BFI, SF-36 and VAS-F.\n* Patients who have received concurrent stimulant medication (e.g. dextroamphetamine or methylphenidate) during the screening period or any medication which may interfere with the study drug.\n* Patients with any delay in chemotherapy treatment such that the screening period extends beyond 21 days.\n* Patients with known central nervous system (CNS) are involved by metastatic cancer.\n* Patients with any serious, uncontrolled, non-malignant medical or psychiatric disorder, or any other medical condition which in the opinion of the investigator may affect the patient's safety or study participation and conduct.\n* Female patients who are pregnant or breastfeeding.\n* Patients with known hepatitis C virus, hepatitis B virus, HIV infection.\n* Patients who have nausea and vomiting or any gastrointestinal disorder that is severe enough to interfere with study drug absorption in the opinion of the investigator.\n* Patients with uncontrolled pain who, in the opinion of the investigator, are not eligible for the study.\n* Patients with known hypersensitivity or intolerance of rosmarinic acid, caffeic acid, and other related phenolic compounds as well as excipients in the Nuvastatic® 300 mg or placebo treatment.\n* Patients with planned therapy or treatment with another investigational agent.\n* Previous exposure to any investigational agent within 4 weeks prior to screening, or planned administration of an Investigational agent, other than as specified by this protocol, during the study period.","ALL",{"count":21,"type":22},[25],"The goal of this clinical trial is to evaluate whether Nuvastatic 300 capsule can reduce cancer-related fatigue in adult patients with colon cancer undergoing first-line chemotherapy.\n\nThe main questions it aims to answer are:\n\nDoes Nuvastatic 300 capsule significantly reduce cancer-related fatigue compared to placebo? Is Nuvastatic 300 capsule safe and well tolerated in this patient population?\n\nResearchers will compare Nuvastatic 300 capsule vs placebo to see if Nuvastatic 300 capsule improves fatigue scores and maintains an acceptable safety profile.\n\nParticipants will:\n\nReceive Nuvastatic 300 capsule or placebo capsules (3 times per day) for 6 cycles of 20 days each (total \\~120 treatment days).\n\nContinue their standard first-line chemotherapy regimen. Provide blood samples assessment at Screening and End of Treatment. Complete patient diaries and fatigue assessments as per protocol.",[28,58],"Colon Cancer",[31,58,32,60,34],"Randomized double blind placebo controlled trial",{"date":38,"type":39},{"date":41,"type":39},{"date":64,"type":22},"2026-11-30",{"name":45,"class":46},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":23,"phases":74,"briefSummary":76,"conditions":77,"keywords":82,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":97},"100640163","biofield-therapy-for-the-support-of-immunotherapy-related-symptoms-among-adult-cancer-patients---a-pilot-study-100640163","NCT07581080","Biofield Therapy for the Support of Immunotherapy-related Symptoms Among Adult Cancer Patients - A Pilot Study","Inclusion Criteria:\n\n* Participants must be greater than 18 years of age.\n* Currently diagnosed with cancer.\n* Actively receiving immunotherapy treatment with ICI (PD1 or -PD-L1 inhibitor (single-agent immunotherapy or immunotherapy in combination with other agents; also including the use of steroids if applicable)\n* Report clinically significant fatigue over the past 7 days.\n* Able to travel to the study site to receive Reiki treatments once a week.\n* Understanding and willing to complete all study procedures.\n* Capable of giving written informed consent.\n* Proficient ability to speak, read, and write in English or Spanish.\n\nExclusion Criteria:\n\n* Individuals currently receiving or received Reiki treatment in the past 30 days\n* Currently diagnosed with a severe psychiatric illness (i.e. schizophrenia, dementia, major depression with suicidal ideations)\n* Currently pregnant or intending to become pregnant during the study timeframe",{"count":73,"type":22},12,[75],"NA","Cancer treatment with immunotherapy is often associated with symptoms such as fatigue, pain, and emotional distress, which may affect patients' daily functioning and quality of life. Additional supportive care approaches are being studied to better understand their potential role in supporting these symptoms.\n\nThe purpose of this study is to learn whether a biofield therapy, called Reiki may help to support adults with cancer who are receiving immunotherapy and currently struggling with fatigue. Reiki is a non-invasive complementary therapy delivered by a trained practitioner who places their hands lightly near the body. It is intended to promote relaxation and support general well-being. Reiki is used as a supportive practice and is not considered a medical treatment or replacement for standard care.\n\nThe secondary goal of this study is to evaluate the feasibility of delivering Reiki in this clinical setting. This includes examining recruitment, retention, adherence to study procedures, and overall participant engagement.\n\nLastly, the third aim is to explore participants' experiences with Reiki through guided interviews.\n\nParticipants enrolled in this study will first be asked to participate in a one-hour, one-on-one interview about their experiences with cancer treatment, their symptoms, and their thoughts about integrative care practices such as Reiki. After the interview, they will be randomly assigned to one of two groups:\n\nImmediate Reiki Group:\n\nIf participants are assigned to this group, they will receive six weekly, in-person 30-minute Usui Reiki sessions from a Reiki master at the Susan Samueli Integrative Health Institute. Before and after each session, participants will complete questionnaires about fatigue, pain, and stress. At the first and final sessions, a small blood sample will be collected to measure inflammatory biomarkers, and Electroencephalogram (EEG) hyperscanning will be conducted to measure brain activity and connectivity between the participant and the practitioner. Four weeks after the final session, they will complete the questionnaires again, followed by a short satisfaction survey about their experience.\n\nWaitlist Group:\n\nIf they are assigned to the waitlist group, they will first complete a 6-week observation period that includes brief weekly fatigue questionnaires and two in-person 30-minute sessions with EEG measurements at Week 1 and Week 6. This will be followed by a 4-week period with no sessions, after which they will complete questionnaires about fatigue, pain, and psychological distress. Participants will then begin the same six weekly, in-person 30-minute sessions described above. As with the Immediate Group, they will complete questionnaires before and after each session. At the first and final sessions, a small blood sample will be collected and EEG hyperscanning will be conducted. At the end of the study, participants will also complete a short satisfaction survey about their experience.\n\nThe investigators hypothesize that participants receiving Reiki will report improvements in symptoms and well-being compared to those not yet receiving Reiki, and that the intervention will be feasible to implement and acceptable to participants.",[78,79,28,80,81],"Cancer","Immunotherapy","Pain","Stress",[83,79,78,84,85,86],"Reiki","fatigue","pain","biofield therapy","2026-05-06",{"date":89,"type":39},"2026-05-12",{"date":91,"type":22},"2026-04-20",{"date":93,"type":22},"2027-01",{"name":95,"class":96},"University of California, Irvine","OTHER",2,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":23,"phases":107,"briefSummary":108,"conditions":109,"keywords":116,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":5},"100570692","revitalize-rct-to-reduce-fatigue-in-adults-with-ovarian-cancer-on-parp-inhibitors-100570692","NCT06710548","REVITALIZE: RCT to Reduce Fatigue in Adults With Ovarian Cancer on PARP Inhibitors","Randomized Trial of REVITALIZE: A Telehealth Intervention to Reduce Fatigue Interference Among Adults With Advanced Ovarian Cancer on PARP Inhibitors","Inclusion Criteria:\n\n* Adult patients (age ≥ 18 years) with ovarian, fallopian tube, or primary peritoneal cancers (hereafter ovarian cancer) who have completed primary therapy (surgery and chemotherapy).\n* Treated with a PARP inhibitor as maintenance therapy for ≥2 months and plan to continue for at least 7 months.\n* English-speaking.\n* Mean fatigue severity level ≥4 on the first three items of the Fatigue Symptom Inventory.\n* ECOG performance status of 0-2.\n* Willing to use a wireless pill bottle for PARP inhibitor medication.\n\nExclusion Criteria:\n\n* Untreated clinical condition or comorbid condition that pre-dates PARP inhibitor use and could explain fatigue, as evaluated by their treating oncologist.\n* Patients with severe psychiatric conditions (e.g. untreated trauma unrelated to cancer, high or imminent suicidality) as evaluated by their treating oncologist, which require more intensive psychiatric treatment than the study can provide.\n* Patients with cognitive conditions (e.g. dementia), determined by their treating oncologist, such that they could not provide informed consent or complete the study procedures.\n* Inability to complete the first questionnaire within one week of consent.",{"count":106,"type":22},240,[75],"The purpose of this study is to see whether a supportive intervention (REVITALIZE) reduces fatigue and its impact on daily life and activities for participants with ovarian cancer taking PARP inhibitors.\n\nThe name of the study groups in this research study are:\n\n1. REVITALIZE\n2. Educational Materials",[110,111,112,113,114,28,115],"Ovarian Cancer","Advanced Ovarian Carcinoma","Fallopian Tube Carcinoma","Primary Peritoneal Cancer","PARP Inhibitor","Fatigue in Cancer Survivors",[110,111,117,113,118,119,115,120],"Advanced Ovarian Cancer","Fallopian Tube Cancer","Fatigue related to cancer treatment","PARP inhibitor","2026-04-07",{"date":123,"type":39},"2026-04-13",{"date":125,"type":39},"2025-03-17",{"date":127,"type":22},"2029-01-31",{"name":129,"class":96},"Dana-Farber Cancer Institute",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":53,"minAge":18,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":23,"phases":140,"briefSummary":141,"conditions":142,"keywords":147,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":166},"100576556","characterization-treatment-and-long-term-follow-up-of-fatigued-patients-in-primary-care-100576556","NCT06786832","Characterization, Treatment, and Long-term Follow-up of Fatigued Patients in Primary Care","iFAS","Inclusion Criteria:\n\n1. age 18-67\n2. enrollment at a primary care clinic in Region Stockholm\n3. severe, functionally disabling fatigue as a central symptom for at least 3 months\n4. The fatigue has an identifiable start and hence has not been life-long;\n5. The fatigue is not a direct effect of an active disease process motivating another treatment (e.g., hypo-\u002Fhyperthyroidism, anemia, cancer, dementia) or the effect of medication\n6. regular access to a computer and to the Internet\n7. ability to read and write in Swedish.\n8. ability to visit a study center for participation in potential assessments and treatment sessions (maximum 60 minutes) and to take part of written material via the internet.\n\nExclusion Criteria:\n\n1. substance abuse disorder in the past 6 months\n2. Current or past psychosis or bipolar disorder\n3. Primary psychiatric disorder of such severity that it merits evidence-based treatment (e.g., obsessive compulsive disorder, moderate to severe depression, post-traumatic stress disorder, anorexia nervosa)\n4. elevated risk for suicide\n5. deliberate self harm in the past 6-months (e.g., cutting, burning, poisoning);\n6. BMI\\>40\n7. Initiated or changed psychopharmacological medication (e.g., for depression or anxiety disorders) in the past month\n8. ongoing chemotherapy\n9. intellectual disability (e.g., severe autism) that affects ability to work with the treatment\n10. pregnancy\n11. life circumstances that complicate or make treatment impossible (e.g., domestic violence, ongoing legal disputes, disputes with social insurance agency, planed or on-going work capacity assesment regarding permanent work disability pension or planed surgery)\n12. ongoing psychological treatment and\u002For multimodal rehabilitation.\n13. working night shifts","67 Years",{"count":139,"type":22},190,[75],"The overarching purpose of this project is to further the understanding of fatigue as a symptom in primary care patients, and to build evidence for a highly accessible treatment targeting fatigue that can be readily implemented in primary care clinics.\n\nData will be collected within a randomized controlled superiority trial. The primary aim is to evaluate the effectiveness of a transdiagnostic cognitive behavioral therapy (tCBT) for fatigued patients as compared to care as usual (CAU). Primary outcome will be change in fatigue severity (as measured by the Checklist Individual Strengths, fatigue subscale) pre- to post-treatment (6 months), with long-term controlled follow-up after 12 months. A register-based follow-up will be conducted up to 60 months post baseline. Moderators and mechanisms of treatment effect will be investigated with the aim to identify potential subgroups of fatigued individuals across and within diagnostic categories that may respond differently to treatment. Lastly, a health economic evaluation of long-term treatment effects will be conducted, which incorporates much needed detailed mapping of care as usual for fatigued patients.",[143,144,145,146,28],"Fatigue","Fatigue Post Viral","Exhaustion Disorder","Fatigue Symptom",[148,149,150,151,152,143,153,154,155,156],"Psychological treatment","Primary care","cognitive behavioral therapy","blended treatment","randomized controlled trial","burnout","chronic stress","register data","cognitive testing","2026-03-09",{"date":159,"type":39},"2026-03-11",{"date":161,"type":39},"2025-02-06",{"date":163,"type":22},"2033-01",{"name":165,"class":96},"Karolinska Institutet",1,{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":175,"sex":53,"minAge":176,"maxAge":177,"enrollmentInfo":178,"targetDuration":4,"studyType":23,"phases":180,"briefSummary":181,"conditions":182,"keywords":186,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":4},"100564593","jacobsons-progressive-muscle-relaxation-technique-on-children-with-leukemia-undergoing-chemotherapy-100564593","NCT06631196","Jacobson's Progressive Muscle Relaxation Technique on Children With Leukemia Undergoing Chemotherapy.","The Effect of Jacobson's Progressive Muscle Relaxation Technique on Anxiety and Fatigue Among Children With Leukemia Undergoing Chemotherapy.","JPMRT","Inclusion Criteria:\n\n* Children diagnosed with leukemia and received chemotherapy sessions.\n* Age ranged from 7 to 15 years.\n\nExclusion Criteria:\n\n* other disorders such as neurological diseases, cerebrovascular accidents, or mental illness.",true,"7 Years","15 Years",{"count":179,"type":22},80,[75],"The goal of this clinical trial is to determine the effect of Jacobson's progressive muscle relaxation technique on anxiety and fatigue among children with leukemia undergoing chemotherapy. The main research hypotheses are;\n\n* Children with leukemia who receive Jacobson's progressive muscle relaxation technique exhibit less anxiety than those who don't receive it.\n* Children with leukemia who receive Jacobson's progressive muscle relaxation technique exhibit less fatigue than those who don't receive it.\n\nResearchers will compare Jacobson's progressive muscle relaxation technique with standardized nursing care on a child's anxiety and fatigue.",[183,184,28,185],"Leukemia","Children","Anxiety",[187,185,143,184,183,188,189],"Jacobson's Progressive Muscle Relaxation Technique","Chemotherapy","nursing care","NOT_YET_RECRUITING","2024-10-07",{"date":193,"type":39},"2024-10-08",{"date":195,"type":22},"2024-11-01",{"date":197,"type":22},"2025-11-30",{"name":199,"class":96},"Alexandria University"]