[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chemotherapy-induced-peripheral-neuropathy-cipn\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chemotherapy-induced-peripheral-neuropathy-cipn":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,26,0,25,[9,47,71,99,130,162,191,228,257,284,305,337,366,394,421,447,474,496,522,544,569,589,613,638,657],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100053286","phase-1-safety-tolerability-and-pk-of-ah-008-following-single-ascending-dose-in-healthy-subjects-100053286",false,"NCT07697560","Safety, Tolerability, and PK of AH-008 Following Single Ascending Dose in Healthy Subjects","A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AH-008 Following Single Ascending Dose Administration in Healthy Subjects","Inclusion Criteria:\n\n1. Age range: 18 to 65 years.\n2. Body Mass Index (BMI) between 19 and 32 kg\u002Fm² (inclusive). Males: Body weight ≥ 50 kg; Females: Body weight ≥ 40 kg\n3. Subjects understand and agree to comply with planned study procedures, can communicate well with the Investigator, understand the requirements of the study, and have provided written informed consent.\n4. Subject is considered healthy, in the opinion of the Investigator, based on a detailed medical history, complete physical examination, vital signs, 12-lead ECG, and safety laboratory tests evaluation.\n5. Female of non-childbearing potential (FONCBP) are considered inclusionary provided they meet one of the following criteria regarding non-childbearing potential:\n\n   (A) Permanently sterile: Permanent and irreversible infertility via documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.\n\n   (B) Postmenopausal: Defined as 12 months of spontaneous amenorrhea. In questionable cases, a blood test with Follicle Stimulating Hormone (FSH) levels \\>40 mIU\u002FmL at Screening will be used to confirm postmenopausal status.\n6. Male subjects are considered inclusionary provided they meet one of the following criteria regarding reproductive potential and partner status:\n\n(A) Partners of Non-Childbearing Potential: Male subjects with female partners of non-childbearing potential (defined as surgically sterile via hysterectomy, bilateral salpingectomy, or bilateral oophorectomy; or confirmed postmenopausal for at least 12 months) are eligible and are not required to use additional contraception.\n\n(B) Partners Using Effective Contraception: Male subjects with female partners of childbearing potential who are already utilizing a highly effective contraceptive method (failure rate of \\\u003C1% per year) are eligible and are not required to use condoms or other barriers, unless the partner is currently pregnant. (C) Vasectomized Males: Males who have undergone a successful vasectomy (at least 3 months prior to dosing) are eligible without further contraceptive requirements.\n\nExclusion Criteria:\n\n1. A history of any clinically serious illness, such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, renal, immunology, psychiatry, and metabolic abnormalities, or any other disease or physiological condition that, in the investigator's judgment may interfere with test results or pose an undue safety risk.\n2. A history of autoimmune disease, spinal trauma, and various demyelinating diseases, including acute inflammatory demyelinating polyneuropathy (Guillain-Barre syndrome).\n3. In the opinion of the investigator, A history of multiple episodes or severe allergies (e.g., food, drug allergy), or has had anaphylactic reaction or significant intolerance to prescription drugs, over-the-counter drugs or foods.\n4. Human Immunodeficiency Virus-Antibody (HIV-Ab), Hepatitis B Surface Antigen (HBsAg) or Hepatitis C Virus-Antibody (HCV-Ab) serologically positive at Screening.\n5. Surgery within 4 weeks prior to Screening or planned to have surgery during the trial period.\n6. Use of any prescription medicine, over-the-counter drug, herbal medicine, including herbal remedies such as St. John's wort, homeopathic and traditional medicines within 14 days or approximately 5 half-lives (whichever is longer) before the first dosing during the trial period, except for paracetamol\u002Facetaminophen, ibuprofen, and hormonal contraceptives.\n7. Participation in any clinical trial and taking any investigational drug 30 days or approximately 5 half-lives (whichever is longer) before the first dosing.\n8. Subjects who have donated or experienced loss of \\>500 mL of whole blood within 90 days prior to Screening, or donated plasma within 14 days prior to Screening, or received a transfusion of blood or blood products within 90 days prior to Screening.\n9. Special dietary requirements or cannot follow a uniform diet during the trial period.\n10. Consumption of excessive amounts of tea, coffee, and\u002For caffeinated beverages per day (more than 8 cups, 1 cup = 250 mL) within 6 months prior to the first dosing and during the trial period.\n11. Positive breath test for alcohol at Screening or at admission, heavy drinkers or regular drinkers within 90 days prior to Screening, i.e., drinking more than 14 units of alcohol per week (1 unit = 360 mL beer or 45 mL 40% spirits or 150 mL wine), or unable to stop using any alcoholic products during the trial period.\n12. Subjects who have smoked more than 5 cigarettes per day, used e-cigarettes or vaping products, or were unable to abstain from any tobacco or nicotine-containing products (including non-tobacco products such as nicotine patches, gum, or lozenges) in the 90 days prior to Screening and throughout the study.\n13. Drug abusers or those who had used soft drugs (e.g., marijuana) within 90 days prior to Screening or hard drugs (e.g., cocaine, phencyclidine, etc.) within 1 year prior to Screening, or who test positive for drugs at Screening or Baseline, will be excluded.\n14. Subjects with resting vital signs outside the following reference ranges at Screening or Baseline, unless deemed not clinically significant by the Investigator: \\\u003C90 mmHg or \\>140 mmHg, diastolic pressure \\\u003C50 mmHg or \\>90 mmHg; Pulse beat \\\u003C50 BPM or \\>100 BPM, respiration \\\u003C12 times\u002Fminute or \\>20 times\u002Fminute.\n15. Subjects with any clinically significant abnormality on 12-lead ECG or a QT interval corrected with the Fridericia formula (QTcF) \\>450 milliseconds for females and \\>430 milliseconds for males at Screening or Baseline.\n16. Subjects with conditions that can potentially reduce drug clearance (eg, renal or hepatic insufficiency) at Screening or Baseline.\n\n    A. Alanine Aminotransferase (ALT) \\> 1.5 x ULN B. Aspartate Aminotransferase (AST) \\> 1.5 x ULN C. Alkaline phosphatase (ALP) \\> ULN D. Glomerular filtration rate (GFR) \\\u003C 80 mL\u002Fmin\u002F1.73 m² as calculated by the CKD-EPI equation.\n\n    E.Total Protein (TP) \\> ULN F. Total Bilirubin (TBIL) \\> 1.2 x ULN G. Gamma-Glutamyl Transferase \\> ULN H. Lactate Dehydrogenase (LDH) \\> ULN I. International Normalized Ratio (INR) \\> 1.5 x ULN\n17. Subjects with significant bleeding or clotting diathesis, as judged by the investigator, that may interfere with venous blood collection or intravenous infusion.\n18. For females of childbearing potential (FOCBP): unwillingness to use a highly effective contraceptive method (method of birth control which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, non-hormonal or hormonal intrauterine devices (IUDs), sexual abstinence or vasectomized partner) during sexual intercourse with a partner of childbearing potential throughout the trial and for 30 days after last dose.\n19. For male subjects who are not surgically sterile (vasectomy) for at least 3 months prior to dosing and who are sexually active with a female partner of childbearing potential (childbearing potential females are defined as women that are neither post-menopausal nor surgically sterile): unwillingness to simultaneously use a condom and a highly effective contraceptive method, as mentioned above, for the female partner throughout the trial and for 30 days after the last dose.\n20. Subjects may not be able to complete the study for other reasons or should not be included in the study as determined by the investigator.",true,"ALL","18 Years","65 Years",{"count":22,"type":23},32,"ESTIMATED","INTERVENTIONAL",[26],"PHASE1","This is a Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, parallel-group, single ascending dose (SAD) study to evaluate the safety, tolerability, and pharmacokinetics of AH-008 administered as a single intravenous infusion in healthy adult subjects. Four sequential dose cohorts will be evaluated, each with sentinel dosing and SRC-reviewed dose escalation.",[29],"Chemotherapy-induced Peripheral Neuropathy (CIPN)",[31,32,33],"Prevention of Chemotherapy-Induced Peripheral Neuropathy;","AH-008","CIPN","RECRUITING","2026-07-06",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":38},"2026-06-10",{"date":42,"type":23},"2026-09",{"name":44,"class":45},"AnHorn Medicines Co. Ltd.","INDUSTRY",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":24,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100603883","the-lilac-device-trial---impact-a-clinical-investigation-on-improving-peripheral-neuropathy-induced-by-chemotherapy-with-advanced-compression-technology---a-safety-and-efficacy-study-100603883","NCT07142304","The Lilac Device Trial - IMPACT: A Clinical Investigation on IMproving Peripheral Neuropathy Induced by Chemotherapy With Advanced Compression Technology - A Safety and Efficacy Study","IMPACT: A Clinical Investigation on IMproving Peripheral Neuropathy Induced by Chemotherapy With Advanced Compression Technology - A Safety and Efficacy Study","IMPACT","Inclusion Criteria:\n\nTo be eligible to participate in this clinical investigation, participants must meet ALL the following criteria:\n\n1. Adults ≥ age 18 with diagnosed solid tumor cancer, who have been deemed appropriate for neo-adjuvant or adjuvant chemotherapy.\n2. Planned intravenous treatment with at least 4 cycles of chemotherapy, with no planned treatment pause for surgery,\n\n   * With one of the following treatments:\n\n     * Chemotherapy regimens based on Oxaliplatin\n\n       * FOLFOX every 2 weeks\n       * FOLFIRINOX every 2 weeks\n     * Chemotherapy regimens based on single-agent Paclitaxel\n\n       * Paclitaxel weekly\n       * Paclitaxel every 3 weeks\n     * Chemotherapy regimens based on Paclitaxel + Carboplatin\n\n       * Paclitaxel weekly with Carboplatin weekly\u002Fevery 3 weeks\n       * Paclitaxel every 3 weeks with Carboplatin every 3 weeks\n   * Concurrent administration of the chemotherapies listed in the inclusion criteria with or without targeted agents\u002Fimmunotherapy at standard doses is allowed (such as trastuzumab, pertuzumab, bevacizumab, pembrolizumab or other immune checkpoint inhibitors).\n3. Hands and feet size within the specified study sizing range.\n4. Plan to complete taxane- or platinum-based chemotherapy in ≤ 12 months.\n5. ECOG performance status 0 - 2.\n6. Willing and able to sign informed consent.\n7. Willing to comply with and tolerate all study procedures including:\n\n   * Wearing the Lilac Glove and Boot devices for the prescribed duration (devices to be fitted before infusion, and worn during infusion and for up to one (1) hours post infusion),\n   * Complete all study related questionnaires.\n8. Participants must be able to complete participant specific questionnaires in the languages available to the study\n\nExclusion Criteria:\n\nParticipants are not eligible to participate in the clinical trial if they meet ANY of the following criteria:\n\n1. Baseline peripheral neuropathy of any kind as defined by NCI CTCAE v5.0 grade \\> 0.\n2. Prior exposure to neurotoxic chemotherapy in the previous 1 year, counted as the period since the last neurotoxic chemotherapy treatment (e.g., taxanes, platinum agents, vinca alkaloids, or bortezomib).\n3. Positive pregnancy test at baseline for participants with child bearing potential, as per standard of care.\n4. Known or suspected allergy or hypersensitivity to any component of the Lilac Glove or Boot device that comes into contact with the study participant. Caution: This product contains natural rubber latex, which may cause allergic reactions.\n5. Any open wounds, sores, cysts or injury on the participant's hand or on part of the upper arm where the device will be applied or on the participant's feet or part of the lower leg where the device will be applied, which in the opinion of the investigator will not be healed prior to infusion commencing or who in the opinion of the investigator will be inappropriate for inclusion in this study.\n6. Clinically significant peripheral arterial ischemia, as per standard of care, in the opinion of the investigator.\n7. Untreated or uncontrolled hypertension, as per standard of care.\n8. Poorly controlled diabetes, as per standard of care, in the opinion of the investigator.\n9. Weight greater than 140 kg at the time of enrollment.\n10. An existing history or suspicion of presence of hand or foot metastasis.\n11. Use of other investigational devices or active compression\u002F cryotherapy interventions for CIPN prevention or management during the study.\n12. Participants who are receiving neuropathy directed systemic therapies at the time of enrollment, namely, Pregabalin, Gabapentin, Amitriptyline, Nortriptyline, Venlafaxine, Duloxetine.\n13. Participants who, in the opinion of the investigator, will be inappropriate for inclusion into this study or will not comply with the requirements of the study.\n14. Participants with cognitive impairment, psychiatric conditions, or mobility limitations that would prevent compliance with study procedures (e.g., inability to wear the device, complete questionnaires, or attend follow-up visits).\n15. Current participation in a clinical study or within the last 30 days prior to screening that may cause peripheral neuropathy.\n16. Participation in this study at an earlier stage.",{"count":56,"type":23},142,[58],"NA","Chemotherapy drugs, used in the treatment of cancer, have the potential of inducing peripheral neuropathy (PN) as a side effect. This side effect is commonly referred to as CIPN, or chemotherapy-induced peripheral neuropathy.\n\nThe Lilac Glove and Boot devices apply a low pressure across the surface of the hands and feet, respectively, to reduce access of chemotherapy to the peripheral nerves on the hands and feet. The small amount of pressure reduces the level of chemotherapy reaching the peripheral nerves, hence increasing the likelihood of nerve preservation during treatment and thus may potentially temporarily prevent the onset of moderate to severe PN symptoms induced by chemotherapy in the hands and feet while receiving treatment",[61],"Chemotherapy Induced Peripheral Neuropathy (CIPN)","2026-06-08",{"date":40,"type":38},{"date":65,"type":38},"2025-10-03",{"date":67,"type":23},"2026-10",{"name":69,"class":45},"Luminate Medical, Inc.",18,{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":24,"phases":81,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":46},"100629936","phase-3-trial-of-a-virtual-exercise-based-rehabilitation-program-to-treat-persistent-chemotherapy-induced-peripheral-neuropathy-cipn-100629936","NCT07481149","Trial of a Virtual Exercise-based Rehabilitation Program to Treat Persistent Chemotherapy-Induced Peripheral Neuropathy (CIPN)","A Pragmatic Randomized Controlled Trial of a Virtual Exercise-based Rehabilitation Intervention for Persistent Chemotherapy-Induced Peripheral Neuropathy (EX-CIPN).","EX-CIPN","Inclusion Criteria:\n\n* diagnosed with any type of cancer\n* received chemotherapy treatment as part of curative-intent therapy (no minimum dose)\n* \\>6 months following chemotherapy completion with no current plans for further chemotherapy\n* report Grade 1 or higher on the numbness and tingling severity item of the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0\n* neuropathic pain 3 or higher on the Neuropathic Pain 4 (DN4) (interview)\n* capable of ambulation and transfers (with or without gait\u002Ftransfer aid) (ECOG score 0-2)\n* are able to communicate sufficiently in English to complete intervention, questionnaires, and consent\n* have access to and able to operate videoconferencing\n\nExclusion Criteria:\n\n* currently meeting all recommendations from the physical activity guidelines for cancer survivors\n* have any neurological conditions influencing cognition (i.e. dementia, Alzheimer's) and preventing safe or appropriate engagement with exercise recommendation\n* have neuropathy that pre-existed chemotherapy receipt (i.e. diabetic neuropathy)\n* currently enrolled in other rehabilitation or exercise-based interventions",{"count":80,"type":23},240,[82],"PHASE3","The purpose of this study is to determine the effectiveness of the EX-CIPN program in reducing the strength of CIPN symptoms and CIPN-related disability and improving the ability to complete everyday activities. This will be done by determining whether it is better to receive the EX-CIPN program or better to receive no additional intervention. To do this, some of the participants in this study will get EX-CIPN and others will receive usual care. Those who receive usual care will be offered EX-CIPN upon study completion. The main question it aims to answer is:\n\n• Is EX-CIPN effective in improving CIPN symptoms for cancer survivors experiencing persistent CIPN?\n\nParticipants in both study groups will be asked to:\n\n• Complete assessments at baseline, immediately post-intervention, and 3-months post-intervention\n\nParticipants in the EX-CIPN group will be asked to:\n\n* Complete an additional aassessment at 6-months post-intervention\n* Complete a 10-week remote, individualized exercise program\n* Receive health coaching calls on weeks 2, 3, 4, 6, and 8 of the intervention\n* Wear a FitBit throughout the study to track physical activity and promote behaviour change",[29],[86,87,88],"cancer rehabilitation","peripheral neuropathy","randomized controlled trial","2026-06-03",{"date":91,"type":38},"2026-06-05",{"date":93,"type":38},"2026-03-30",{"date":95,"type":23},"2029-07",{"name":97,"class":98},"University Health Network, Toronto","OTHER",{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":24,"phases":110,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":46},"100637464","efficacy-of-spinal-cord-stimulation-in-chemotherapy-induced-peripheral-neuropathy-100637464","NCT07579611","Efficacy of Spinal Cord Stimulation in Chemotherapy-Induced Peripheral Neuropathy","Efficacy of Posterior Spinal Cord Stimulation in Chemotherapy-Induced Peripheral Neuropathic Pain: A Multicenter Randomized Crossover Trial","CHEMOSTIM","Inclusion Criteria:\n\n1. Adult patient with chemotherapy-induced painful neuropathy (platinum salts, vincristine, taxanes, alkaloids, epothilone, thalidomide, etc.) evolving for at least 1 year\n2. Indication for spinal cord stimulation validated by a multidisciplinary team meeting according to SFETD\u002FSFNM guidelines\n3. Resistance to pharmacological or topical treatment (failure of at least two therapeutic lines or intolerable side effects: anticonvulsants, antidepressants, capsaicin, etc.)\n4. Pain score \\> 5\u002F10 on numerical scale in the lower limbs\n5. Patient able to understand and give informed consent to the protocol\n6. Patient affiliated to the French Social Security system\n7. Patient able to complete follow-up questionnaires\n\nExclusion Criteria:\n\n* 1\\. Contraindication to spinal cord stimulation:\n* Extensive laminectomy\n* Coagulopathy\n* Intercurrent infections\n* Psychiatric disorders\n\n  2\\. Body Mass Index (BMI) \\> 40\n\n  3\\. Life expectancy \\\u003C 1 year\n\n  4\\. Ongoing pregnancy\n\n  5\\. Patient under guardianship or curatorship\n\n  6\\. Patient already implanted with a spinal cord stimulation device","100 Years",{"count":109,"type":23},68,[58],"Chemotherapy-induced peripheral neuropathy (CIPN) is a frequent and debilitating side effect of many cancer treatments. It affects 28 to 48% of patients receiving chemotherapy. Symptoms include tingling, numbness, burning sensations, and pain mainly in the hands and feet. While CIPN often improves after chemotherapy ends, in some patients the pain persists and becomes chronic, severely impairing quality of life, sleep, and daily functioning.\n\nCurrently, no treatment has been shown to prevent CIPN. For patients with chronic pain, duloxetine is the only recommended drug, but its efficacy is limited. When standard medications fail, patients have very few options.\n\nSpinal cord stimulation (SCS) is a well-established neurosurgical technique used to treat various forms of chronic neuropathic pain, including pain after surgery, trauma, or diabetes. In this procedure, thin electrodes are placed in the epidural space near the spinal cord and connected to a small implantable pulse generator. The electrical impulses delivered by the device modulate pain signals in the nervous system.\n\nPreliminary case reports suggest that SCS may be effective in patients with CIPN, but no randomized controlled trial has yet established its value in this specific indication. The CHEMOSTIM study aims to fill this gap.\n\nCHEMOSTIM is a multicenter, prospective, randomized crossover trial. All enrolled patients will undergo SCS implantation. Participants will then be randomized to receive either active stimulation first followed by sham stimulation, or sham stimulation first followed by active stimulation. In the sham phase, the device is implanted but switched off following a simulated programming session, so patients cannot tell which phase they are in.\n\nThe primary outcome is the proportion of patients achieving more than 50% pain reduction on a Visual Analog Scale (VAS) during the active stimulation phase compared to the sham stimulation phase, assessed at 4 months.\n\nSecondary outcomes include changes in quality of life, anxiety and depression, sleep quality, medication use, individualized goal attainment, neurological examination, and nerve conduction studies. The study will also evaluate post-stimulation effects and complications.\n\nEligible patients are adults with chronic CIPN evolving for at least one year, with pain greater than 5\u002F10 in the lower limbs, who have failed at least two lines of pharmacological treatment (antidepressants, anticonvulsants, topical agents, etc.) and whose indication for SCS has been validated by a multidisciplinary team following SFETD\u002FSFNM guidelines.",[113,29,114],"Neuropathic Pain","Cancer-related Pain",[116,117,118,119],"spinal cord stimulation","posterior cord stimulation","neuropathic pain","Chemotherapy-induced neuropathy","NOT_YET_RECRUITING","2026-05-06",{"date":123,"type":38},"2026-05-12",{"date":125,"type":23},"2026-09-01",{"date":127,"type":23},"2029-05-01",{"name":129,"class":98},"Assistance Publique Hopitaux De Marseille",{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":24,"phases":140,"briefSummary":142,"conditions":143,"keywords":147,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":161},"100563296","phase-2-spendd-quantitative-sensory-testing-and-analgesic-response-for-painful-peripheral-neuropathy-100563296","NCT06614322","SPENDD: Quantitative Sensory Testing and Analgesic Response for Painful Peripheral Neuropathy.","Sensory Phenotyping to Enhance Neuropathic Pain Drug Development (SPENDD): A Randomized, Double-blinded Cross-over Clinical Trial Aimed at Investigating Whether Bedside Quantitative Sensory Testing Can Predict Response to Analgesics.","5\\. INCLUSION AND EXCLUSION CRITERIA\n\nInclusion Criteria:\n\nPatients eligible for inclusion in this study must fulfill all of the following criteria:\n\n1. Between 18 and 80 years old (inclusive).\n2. Have a diagnosis of peripheral neuropathic pain in both feet from generalized distal sensory polyneuropathy based on the following criteria\n\n   1. A history of a relevant lesion of the peripheral nervous system, disease, toxic exposure, or no known cause (i.e., idiopathic).\n   2. Pain distribution in a neuroanatomically plausible distribution consistent with a symmetrical generalized polyneuropathy (i.e., with a \"glove and stocking\" distal to proximal gradient).\n   3. DN4 score≥ 4\n3. Have experienced the neuropathic pain in the feet for at least 6 months.\n4. Have at least one of the following sensory signs upon clinical examination: abnormal pinprick perception, allodynia, hyperalgesia, abnormal light touch perception, abnormal vibratory perception, or abnormal proprioception.\n5. Have average daily baseline worst pain intensity in their feet of 4 or greater and less than 10, on a 0-10 numeric rating scale of pain intensity (0 = \"no pain,\" 10= \"most intense pain imaginable\") as measured on the daily diary during screening from at least 5 measurements.\n6. Able to understand and read English. This requirement is to ensure that participants can provide informed consent and complete PROs.\n7. Have been on stable dosages of all pain medications or using all non-pharmacologic treatments for neuropathy pain at consistent frequency for at least 1 month and willing and able to stay on those dosages (or use those frequencies) (except acetaminophen rescue) throughout the duration of the study.\n8. If taking cannabinoid products for any reason, must be at stable dosages for at least 1 month prior to the screening visit and willing to stay on that dosage for the duration of the study.\n9. Willing and able to complete electronic patient-reported outcomes at home using a REDCap link.\n\nExclusion Criteria:\n\n* Exclusion criteria 10, 13, 14, 20 pertain only to trial protocols that include duloxetine.\n\n  * Exclusion criterion 11, 19 pertain only to trial protocols that include pregabalin.\n\n    1. Taking any opioid medication with a daily mean morphine equivalent (MME) of \\> 30.\n    2. Have a different diagnosis of pain in the feet including but not limited to musculoskeletal pain (e.g., foot arthritis, plantar fasciitis) or lumbar sacral radiculopathy that they rate to be worse than their neuropathic pain in their feet, or that in the opinion of the investigator, precludes the participant from rating their neuropathy pain in their feet.\n    3. Have a central cause of neuropathic pain (e.g., demyelinating disease, spinal cord injury, Parkinson's disease).\n    4. Have a history of an inciting traumatic or surgical cause that corresponds with the development of features consistent with a peripheral neuropathy.\n    5. Bilateral polyradiculopathy, with a distal distribution (i.e., symptoms extending into the feet).\n    6. History of acute polyneuropathy (e.g., Guillain-Barre Syndrome, acute motor sensory axonal neuropathy \\[AMSAN\\]) within 6 months prior to Visit 1.\n    7. Have autoimmune-mediated neuropathy (e.g., RA, lupus, Sjogren syndrome, Lyme disease, chronic inflammatory demyelinating polyneuropathy (CIDP)) unless the associated inflammation is controlled and, in the opinion of the investigator, is expected to remain stable throughout the course of the study.\n    8. Charcot-Marie-Tooth disease in which nociceptive pain from joint deformity confounds assessment of neuropathic pain.\n    9. Have taken the treatment that caused the participant's neuropathy (e.g., neurotoxic chemotherapy, certain HIV therapies) less than 6 months prior to Visit 1.\n    10. Have taken duloxetine (at least 60mg\u002Fday) in the past 6 months or have taken duloxetine at any dosage within a week prior to the screening visit.\\*\\*\n    11. Have taken pregabalin (at least 300mg\u002Fday) OR gabapentin (at least 1200mg\u002Fday) in the past 6 months or have taken pregabalin or gabapentin at any dosage within a week prior to the screening visit.##\n    12. Have ever previously taken BOTH pregabalin (or gabapentin) AND duloxetine at sufficient dosages and for a sufficient length of time that, in the opinion of the investigator, the participant should have experienced pain relief if they were going to respond, but they did not receive benefit from EITHER drug.\n    13. Taking venlafaxine, buproprion, tramadol, or St. John's Wort. Concomitant use of one medication that inhibits the reuptake of serotonin is allowed at certain dosages. (See Appendix A for maximum allowed dosages for common selective serotonin reuptake inhibitors (SSRIs) and tricyclic antidepressants (TCAs); maximum dosages for other applicable drugs will be decided by the research team leadership composed of a) clinical pharmacist with extensive experience in chronic pain management, b) a physician board-certified in pain medicine and psychiatry, and c) a board-certified neurologist.\\*\\*\n    14. Taking a monoamine oxidase inhibitor.\\*\\*\n    15. Taking CYP1A2 inhibitors or thioridazine.\n    16. Have a spinal cord stimulator.\n    17. Have an active, uncontrolled\u002Funstable medical condition (e.g., neurological, gastrointestinal, renal, hepatic, cardiovascular, pulmonary, metabolic, endocrine, hematological, genitourinary, cancer, or other major disorder), psychotic disorder or any other uncontrolled psychiatric illness that in the opinion of the investigator makes it unsafe to participate or inclusion of the participant will have a negative effect on the study.\n    18. Had a clinically significant illness or operative procedure within four weeks of screening.\n    19. Known hypersensitivity to pregabalin. ##\n    20. Known hypersensitivity to duloxetine.\\*\\*\n    21. Known history of chronic kidney disease that in the opinion of the investigator would make it unsafe to participate.\n    22. Known history of chronic liver disease that in the opinion of the investigator would make it unsafe to participate.\n    23. Excessive consumption of alcohol (i.e., more than 5 drinks \u002F day for males and more than 4 drinks \u002F day for females).\n    24. A history of illicit drug use in the past year or planning to take any illicit drugs during the course of the study (other than cannabinoid products).\n    25. Patients who are at significant risk of suicide, or are a danger to self or others, in the opinion of the investigator, based upon clinical interview and the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening and baseline. Affirmative answer to suicidal ideation questions 4 or 5, within the last 6 months and \u002F or suicidal behavior (actual attempt, interrupted attempt, aborted attempt, and\u002For preparatory acts\u002Fbehavior) within the last 2 years are exclusionary.\n    26. Evidence of cognitive impairment including dementia or a psychiatric condition (e.g., schizophrenia, bipolar disorder) that may interfere with the subject's ability to complete assessments.\n    27. Amputation of lower limbs (foot, ankle, leg, or thigh). Isolated toe amputations are permitted.\n    28. Pregnant or planning to become pregnant during the study period or breastfeeding (screened via self-report).\n    29. Enrolled in another investigational medication trial or a trial of any intervention for pain in your feet.\n    30. Unable or unwilling to provide informed consent.\n    31. Any additional reason that, in the opinion of the site investigator, would make it unsafe to participate or inclusion of the participant would hurt the study.","80 Years",{"count":139,"type":23},190,[141],"PHASE2","The goal of this clinical trial is to determine whether quantitative sensory testing (QST) can be used to classify participants into pain sub-groups and predict who will respond best to certain pain treatments in participants with painful peripheral neuropathy.\n\nThe analgesic effect is evaluated by measuring pain intensity and Patient Global Impression of Change (PGIC).\n\nThis study is a 3-period cross-over trial. This means researchers will compare 3 different drugs (pregabalin, duloxetine, and placebo) over a period of 19 weeks.\n\nParticipants will:\n\n* Undergo a quantitative sensory testing (QST) exam.\n* Provide a blood sample.\n* Complete questionnaires on the computer.\n* Take the study drug as instructed.",[144,145,61,146],"Painful Peripheral Neuropathy","Diabetic Peripheral Neuropathic Pain (DPN)","Idiopathic Peripheral Neuropathy",[148,149,150,151],"Peripheral Neuropathy","Pregabalin","Duloxetine","QST","2026-04-20",{"date":154,"type":38},"2026-04-23",{"date":156,"type":38},"2026-01-29",{"date":158,"type":23},"2028-06",{"name":160,"class":98},"University of Rochester",7,{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":168,"minAge":19,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":24,"phases":171,"briefSummary":172,"conditions":173,"keywords":176,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":46},"100590237","the-effect-of-cold-salt-water-foot-bath-on-the-development-of-chemotherapy-induced-peripheral-neuropathy-100590237","NCT06964802","The Effect of Cold Salt Water Foot Bath on the Development Of Chemotherapy-Induced Peripheral Neuropathy","Inclusion Criteria:\n\n* Women aged 18 and over.\n* Conscious\n* Speaking and understanding Turkish\n* The diagnosis was breast cancer\n* Those who will receive paclitaxel chemotherapy\n* These are patients who answered 'no' to the 'A' section of the CIPNAT scale\n\nExclusion Criteria:\n\n* Responding to the vibration test (if the practitioner does not feel the vibration when the patient says they feel the vibration, it means that neuropathy is present)\n* Feeling pressure in one or none of the three areas on the plantar surface of the foot according to the monofilament test\n* Previous chemotherapy-associated peripheral neuropathy\n* Diagnosed with diabetes\n* Open wounds or skin ulcers on the foot\n* With peripheral and central nervous system disease\n* Peripheral vascular disease,\n* Patients with bone or soft tissue metastases","FEMALE",{"count":170,"type":23},30,[58],"This prospective, randomised, controlled study was designed to evaluate the effectiveness of salt and unsalted cold water foot baths in preventing chemotherapy-induced peripheral neuropathy (CIPN) in patients receiving paclitaxel. The study's sub-objectives were to minimise the development of CIPN, reduce its severity and incidence of symptoms, and minimise its impact on daily life and activities.\n\nHypothesis(es):\n\nH1: Salt cold water foot bath affects the development of chemotherapy-induced peripheral neuropathy.\n\nH2: There is an effect of unsalted cold water foot bath on the development of chemotherapy-induced peripheral neuropathy.\n\nH3: The effects of salt and unsalted cold water foot baths on the development of chemotherapy-induced peripheral neuropathy.\n\nH4: Salt and unsalted cold water foot baths are more effective than standard clinical care in the development of chemotherapy-induced peripheral neuropathy.\n\nResearchers will compare the salt cold water with the unsalted cold water, unsalted cold water and control group to determine whether the salt cold water has an effect on CIPN.\n\nThe experimental group and active comparator participants will continue the application for 12 cycles (12 weeks) of paclitaxel. The application will be applied by researcher Tuba Eryiğit. In addition, before each application for 12 weeks, the severity of CIPN, its effect on daily life and grade will be evaluated.\n\nThe control group will continue clinical routine care applications for 12 cycles (12 weeks). In addition, the severity of CIPN, its effect on daily life and grade will be evaluated before each treatment in the same way as the experimental groups.",[174,61,175],"Breast Cancer Patients","Paclitaxel-induced Peripheral Neuropathy",[177,178,179,180,181],"Chemotherapy-Induced Peripheral Neuropathy","Cold Salt Water","Foot Bath","Breast Cancer","Paclitaxel","2026-04-13",{"date":184,"type":38},"2026-04-16",{"date":186,"type":38},"2025-06-01",{"date":188,"type":23},"2026-07-01",{"name":190,"class":98},"Tuba Eryiğit",{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":18,"minAge":199,"maxAge":200,"enrollmentInfo":201,"targetDuration":4,"studyType":24,"phases":202,"briefSummary":203,"conditions":204,"keywords":209,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":4},"100632041","whole-body-vibration-on-balance-risk-of-falling-and-quality-of-life-in-chemotherapy-induced-peripheral-neuropathy-100632041","NCT07508527","Whole-Body Vibration on Balance, Risk of Falling and Quality of Life in Chemotherapy-Induced Peripheral Neuropathy","Effect of Whole Body Vibration on Balance, Risk of Falling, and Quality of Life in Patients With Chemotherapy Induced Peripheral Neuropathy","WBV\u002FQOL\u002FCIPN","Inclusion Criteria:\n\n* 30 patients diagnosed with chemotherapy-induced peripheral neuropathy from both genders.\n* Their ages will range from 30-60 years old.\n* All patients included in this study will be on chemotherapy from at least one cycle as a treatment of malignant tumor.\n* The patients will be mild to moderate neuropathy according to mTNS.\n* They were medically stable.\n\nExclusion Criteria:\n\n* History of other types of neuropathies (i.e., hereditry peripheral neuropathy associated with nutritional agents and paraneoplastic syndrome-related neuropathy…etc).\n* Unstable medical condition during chemotherapy\n* Patients who are starting new therapy or dose modification during study period\n* Morbid obesity body mass index \\>40%\n* History of non-surgically repaired nerve compression injuries such as carpal tunnel, brachial plexopathy, spinal stenosis, and spinal nerve root compression\n* History of central nervous system primary or metastatic malignancy.","30 Years","60 Years",{"count":170,"type":23},[58],"The goal of this clinical trial is to evaluate the efficacy of Whole-body vibration in improving postural control, risk of falling, and quality of life in patients with chemotherapy-induced peripheral neuropathy. The main questions it aims to answer are:\n\nDoes Whole-body vibration have a significant effect on postural control, risk of falling, and quality of life in patients with chemotherapy-induced peripheral neuropathy?\n\nResearchers will compare whole body vibration in addition to traditional exercise to traditional exercise alone to see if Whole-body vibration have a significant effect on postural control, risk of falling, and quality of life in patients with chemotherapy-induced peripheral neuropathy.\n\nParticipants will:\n\n* age between 30-60 years old.\n* be on chemotherapy for at least one cycle as a treatment of malignant tumors with peripheral neuropathy.\n* have mild to moderate neuropathy according to mTNS.\n* be assigned randomly into two equal groups (control group (A) and study group (B)).\n* Take three sessions per week for eight weeks.\n* The control group (A) will be treated by selected physical therapy treatment (Strength resistive training, Stretching \\& flexibility, Balance training)\n* The study group (B) will be treated with selected physical therapy treatment in addition to whole-body vibration therapy.",[205,61,206,207,208],"Whole Body Vibration","Fall Risk, Fall Prevention","Balance","Quality of Life",[210,211,33,212,207,213,214,215,216,217,218],"WBV","Whole body vibration","Chemotherapy induced peripheral neuropathy","Risk of fall","falling","postural control","fall","QOL","Quality of life","2026-03-31",{"date":221,"type":38},"2026-04-02",{"date":223,"type":23},"2026-04",{"date":225,"type":23},"2027-06",{"name":227,"class":98},"Cairo University",{"id":229,"slug":230,"hasResults":12,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":107,"enrollmentInfo":235,"targetDuration":4,"studyType":237,"phases":4,"briefSummary":238,"conditions":239,"keywords":240,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":46},"100631377","intrathecal-ziconotide-in-chemotherapy-induced-peripheral-neuropathy-100631377","NCT07499882","Intrathecal Ziconotide in Chemotherapy Induced Peripheral Neuropathy","Observational and Data Collection Study About Intrathecal Ziconotide in the Treatment of Chemotherapy Induced Neuropathy","Inclusion Criteria:\n\n* Adult patients, ages 18-100, with chemotherapy-induced peripheral neuropathy as a primary source of pain\n* The patient is already scheduled to be treated with TDD using ziconotide (no reported allergies to ziconotide or drug-drug interactions expected)\n* Patient will have, or is scheduled to have, Medtronic Synchromed Intrathecal Pump implanted by Dr. Beuer (outside of the research)\n* Patients already taking nonopioid analgesics will be allowed to continue their prescribed medication regimen.\n* Patients currently taking opioid analgesics must undergo a washout period of 2 weeks (prior to device implant) before participating in this study. Those unable to adhere to this washout period will be excluded\n\nExclusion Criteria:\n\n* Patients with other forms of neuropathy (diabetic, idiopathic) will be excluded\n* Patients with a spinal cord stimulator will be excluded\n* Patients with contraindications to intrathecal ziconotide will be excluded\n* Patients who cannot sign the consent, participate in research activities, or those who require a legally authorized representative (LAR) will be excluded\n* Patients who are pregnant and\u002For nursing or planning to become pregnant are excluded\n* Also excluded are those inaccessible for follow-up, participation is excluded by local law, or a patient is currently enrolled or plans to enroll in a concurrent drug\u002Fdevice study",{"count":236,"type":23},24,"OBSERVATIONAL","The purpose of this observational, data collection, research is to evaluate if ziconotide, a commercially approved medication given by a FDA cleared intrathecal pump, for chronic pain is effective in the treatment of chemotherapy-induced peripheral neuropathy (CIPN) a common and often long-lasting side effect of cancer treatment.",[61],[241,242,243,244,245,246,247,248],"intrathecal pump","ziconotide","chronic pain","targeted drug delivery","neuropathy","cipn","chemotherapy induced neuropathy","neuropathy after cancer treatment","2026-03-25",{"date":93,"type":38},{"date":252,"type":23},"2026-05-02",{"date":254,"type":23},"2028-05-01",{"name":256,"class":98},"Christian Hospital Northeast Northwest",{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":264,"enrollmentInfo":265,"targetDuration":4,"studyType":237,"phases":4,"briefSummary":266,"conditions":267,"keywords":269,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":46},"100593690","relationship-between-great-toe-strength-and-symptoms-of-chemotherapy-induced-peripheral-neuropathy-cipn-100593690","NCT07009717","Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)","The Role Of Great Toe Strength And Its Association With The Severity Of Symptoms Of Chemotherapy-Induced Peripheral Neuropathy (CIPN)","Eligibility Criteria for Chemotherapy-Induced Peripheral Neuropathy (CIPN) group:\n\nInclusion Criteria:\n\n* At least 18 years of old with the ability to independently raise and low (extend or flex) the great toe\n* Able to consent and complete questionnaires in English independently and have normal to corrected vision (self-reported)\n* Within 3 - 6 months of starting chemotherapy and a confirmed diagnosis of CIPN using the current clinical reference standard of Nerve conduction study.\n\nExclusion Criteria:\n\n* Comorbidities including but not limited to diabetes, arthritis, hypertension, thyroid disease, and heart disease, . that have been reported to be associated with the incidence of peripheral neuropathy and\u002For progression of CIPN.\n* Toe deformities or impairments not caused by CIPN (including but not limited to hallux valgus\u002Fvarus, hallux limitus, hallux rigidus, hammer toe deformity, claw toe, bunions, webbed toes)\n* Self-reported impairment or impact on the strength of the foot, ankle, and\u002For great toe due to past medical or surgical history.\n\nEligibility Criteria for Healthy Control group: The participants recruited for this group will be age- and sex- matched to the CIPN group\n\n* Inclusion Criteria:\n* At least 18 years of old with the ability to independently raise and low (extend or flex) the great toe\n* Able to consent and complete questionnaires in English independently and have normal to corrected vision (self-reported)\n* No known health conditions that have been reported to be associated with different impairements in mobility, balance, and muscle strength (particularly in the lower extremity)","90 Years",{"count":170,"type":23},"Great Toe Strength (GTS) is a potential clinical biomarker that has been associated with functional mobility and health; Additionally, GTS has been identified in the literature as one of the early symptoms of chemotherapy-induced peripheral neuropathy (CIPN). The purpose of this research study is to evaluate GTS in individuals with CIPN and healthy adults using ToeScale and see how it relates to nerve issues from chemotherapy. Additionally, we aim to assess the usability of the novel GTS assessment device, ToeScale among the participants. As a part of this study visit, you will complete some questionnaires followed by GTS and balance and gait assessments.",[29,268],"Healthy",[270,271,272,273,274],"Great Toe strength","chemotherapy-induced peripheral neuropathy","muscle weakness","clinical biomarker","force development curve","2026-02-09",{"date":277,"type":38},"2026-02-10",{"date":279,"type":38},"2025-08-05",{"date":281,"type":23},"2026-12-31",{"name":283,"class":98},"University of Florida",{"id":285,"slug":286,"hasResults":12,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":291,"enrollmentInfo":292,"targetDuration":4,"studyType":24,"phases":294,"briefSummary":295,"conditions":296,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":46},"100621950","acupuncture-and-compression-for-the-prevention-of-cipn-in-breast-cancer-patients-100621950","NCT07377279","Acupuncture and Compression for the Prevention of CIPN in Breast Cancer Patients","Acupuncture and Compression for the Prevention of Peripheral Neuropathy Induced by Taxane-based Chemotherapy in Breast Cancer Patients: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age 18-70 years old and have signed an informed consent form;\n2. Patients with histologically confirmed non-recurrent early or intermediate-stage breast cancer;\n3. Patients scheduled to receive cyclical adjuvant or neoadjuvant chemotherapy based on taxane drugs (4-cycle or single-cycle regimen);\n4. No prior exposure to breast cancer-related chemotherapy, immunotherapy, or endocrine therapy;\n5. Cardiac echocardiography showing cardiac ejection fraction within normal range;\n6. Eastern Cooperative Oncology Group (ECOG) physical status ≤1;\n7. No psychiatric or cognitive impairments, capable of understanding and completing assessment scales;\n8. No CIPN at baseline (NCI-CTCAE 5.0 and TNSc grading ≤0);\n9. Good organ function meeting the following criteria: Hb ≥90g\u002FL, WBC ≥3.5×10⁹\u002FL, platelets ≥100×10⁹\u002FL, neutrophils ≥1.5×10⁹\u002FL, AST ≤3× upper limit of normal, ALT ≤3× upper limit of normal, bilirubin ≤1.5× upper limit of normal, serum creatinine ≤1.5× upper limit of normal;\n10. Fertile women must agree to use effective contraception for 7 days before first dosing through 24 weeks post-treatment. Fertile women must have a negative serum pregnancy test within 7 days before first dosing.\n\nExclusion Criteria:\n\n1. Patients with active infections, skin lesions on hands\u002Ffeet, or contraindications to chemotherapy, acupuncture, or compression therapy;\n2. Patients with prior exposure to neurotoxic agents (e.g., taxanes, oxaliplatin, platinum-based drugs, vincristine) or platinum-containing chemotherapy regimens;\n3. Patients who received acupuncture for other conditions within the past month;\n4. Patients with conditions predisposing to peripheral neuropathy symptoms (e.g., alcoholism, uremia, diabetes, autoimmune disorders, rheumatoid arthritis, cervical spondylosis, severe mental illness, severe trauma);\n5. Patients with Raynaud's syndrome, cold intolerance, peripheral arterial ischemia, or hand-foot syndrome;\n6. Patients receiving medications that may mask CIPN symptoms (e.g., SSNRI, SSRI, tricyclic antidepressants, B-complex vitamins);\n7. Patients with lymphedema in acupuncture stimulation areas;\n8. Patients with phobia of electroacupuncture or stainless steel needle allergy;\n9. Patients with severe non-malignant conditions that may compromise treatment adherence or pose risks;\n10. Patients undergoing concurrent anti-tumor therapy or clinical trials;\n11. Patients with dementia, cognitive impairment, or psychiatric conditions affecting informed consent comprehension;\n12. Patients with known allergy history or contraindications to trial procedures;\n13. Patients with uncontrolled cardiac symptoms or conditions, including: (1) NYHA class 2 or higher heart failure; (2) unstable angina; (3) myocardial infarction within the past year; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment;\n14. Cardiac pacemaker implantation;\n15. Known hereditary or acquired bleeding\u002Fthrombosis predispositions (e.g., hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.).","70 Years",{"count":293,"type":23},384,[58],"As a core component of comprehensive breast cancer treatment, chemotherapy frequently induces chemotherapy-induced peripheral neuropathy (CIPN), particularly with taxane-based agents. The incidence of CIPN reaches 68.1% within the first month of chemotherapy, and over 30% of patients experience persistent symptoms for more than 6 months. The resulting sensorimotor dysfunction significantly impairs patients' quality of life, necessitates dose reduction or treatment discontinuation, and ultimately affects survival outcomes. Currently, no prophylactic pharmacological or non-pharmacological interventions have received Grade I recommendations in domestic or international guidelines and expert consensuses. The compression therapy demonstrated definite preventive value in the POLAR trial. Its low cost and high tolerability confer substantial clinical applicability, earning it a Grade III recommendation in ESMO guidelines. Meanwhile, single-arm trials of acupuncture have reported a 51.2% symptom relief rate and a trend toward reduced high-grade CIPN. As non-pharmacological interventions, acupuncture and compression therapy hold complementary potential in preventing taxane-induced CIPN: compression therapy locally blocks drug exposure, while acupuncture systemically regulates neural function.However, three core challenges persist in the current research field: insufficient evidence quality for single-intervention strategies, lack of systematic evaluation of combined interventions, and the absence of risk-stratified prevention models. To address these gaps, this study aims to conduct a prospective randomized controlled trial to concurrently evaluate the preventive efficacy of compression therapy, acupuncture, and their combination for taxane-induced CIPN. The goal is to provide high-level evidence-based medicine to support the development of individualized prevention strategies.",[180,29],{"date":298,"type":38},"2026-02-02",{"date":300,"type":38},"2025-09-01",{"date":302,"type":23},"2028-09-30",{"name":304,"class":98},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":306,"slug":307,"hasResults":12,"nctId":308,"briefTitle":309,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":24,"phases":313,"briefSummary":314,"conditions":315,"keywords":319,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":46},"100578130","feasibility-testing-of-a-tai-chi-program-for-chemotherapy-induced-peripheral-neuropathy-treatment-tct-100578130","NCT06807294","Feasibility Testing of a Tai Chi Program for Chemotherapy-Induced Peripheral Neuropathy Treatment (TCT)","Inclusion Criteria:\n\n* Age 18 years old and older\n* Cancer survivors with no evidence of disease (cancer);\n* Completed neurotoxic chemotherapy, i.e., platinum agents, taxanes, vinca alkaloids, and bortezomib, at least three months before enrollment;\n* A CIPN diagnosis based on symptom history, loss of deep tendon reflexes, or presence of symmetrical stocking-glove pain, numbness, or paresthesia;\n* Answers \"yes\" to the following question: \"Do you feel as though your balance is affected from experiencing CIPN?\" or \"Are you afraid of falling as a result of your CIPN?\";\n* On a stable regimen (no change in past three months) if taking anti-neuropathy or other pain medications;\n* Eastern Cooperative Oncology Group (ECOG) Performance Status Scale score ≤ 2\n* Willing to adhere to all study-related procedures, including randomization to the Tai Chi or waitlist group, 2 in-person visits to Dana-Farber Cancer Institute (DFCI) (one within 2 weeks of enrollment and one at week 12);\n* Willing to adhere to requirement that no new pain medication be taken throughout the study period; and\n* Individuals receiving endocrine therapy or targeted\u002Fantibody therapy, such as trastuzumab, pertuzumab, or immunotherapy, will be eligible to participate.\n\nExclusion Criteria:\n\n• Patients who have received physical therapy or Tai Chi training, specifically for CIPN, in the past three months.",{"count":312,"type":23},21,[58],"This research is being done to determine whether a 12-week virtual Tai Chi training program, designed to improve balance and small nerve fiber function, is feasible and acceptable among cancer survivors with chemotherapy-induced peripheral neuropathy (CIPN).",[61,316,317,318],"Peripheral Neuropathy Due to Chemotherapy","Peripheral Neuropathies","Neuropathy",[148,320,321,33,322,323,324,325,326,218,327,328],"Chemotherapy Induced Peripheral Neuropathy","Cancer survivor","Tai Chi","Balance training","Falls prevention","Non-pharmacological intervention","Mind-body exercise","Feasibility study","Pilot study","2026-01-27",{"date":156,"type":38},{"date":332,"type":38},"2026-01-16",{"date":334,"type":23},"2026-10-31",{"name":336,"class":98},"Dana-Farber Cancer Institute",{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":12,"sex":18,"minAge":199,"maxAge":200,"enrollmentInfo":344,"targetDuration":4,"studyType":24,"phases":346,"briefSummary":347,"conditions":348,"keywords":349,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":46},"100621270","effect-of-feedback-based-balance-training-on-balance-and-gait-in-cancer-patients-with-chemotherapy-induced-peripheral-neuropathy-100621270","NCT07368439","Effect of Feedback-Based Balance Training on Balance and Gait in Cancer Patients With Chemotherapy-Induced Peripheral Neuropathy","Effects of Feedback-Based Balance Training on Balance and Gait Performance in Cancer Patients With Chemotherapy-Induced Peripheral Neuropathy (CIPN): A Randomized Controlled Trial","Inclusion Criteria:\n\nAdults aged 30 to 60 years\n\nDiagnosed with breast, rectal, or stomach cancer\n\nHistory of treatment with neurotoxic chemotherapy\n\nPresence of chemotherapy-induced peripheral neuropathy as indicated by an EORTC CIPN20 total score of 24 or higher\n\nAbility to walk independently for at least 6 meters, with or without an assistive device\n\nMedically stable and able to participate in physiotherapy\n\nExclusion Criteria:\n\n* Peripheral neuropathy due to causes other than chemotherapy (e.g., diabetes mellitus)\n\nHistory of neurological disorders affecting balance or gait (e.g., stroke, Parkinson's disease)\n\nSevere musculoskeletal conditions affecting balance or lower limb function\n\nActive foot ulcers, infections, or soft tissue injuries\n\nSevere visual impairment affecting balance\n\nAny medical condition that, in the investigator's judgment, would interfere with safe participation",{"count":345,"type":23},70,[58],"Chemotherapy-induced peripheral neuropathy (CIPN) is a common complication of cancer treatment that can cause numbness, tingling, pain, balance problems, and difficulty walking. These symptoms may increase the risk of falls and reduce independence and quality of life in cancer survivors.\n\nThe purpose of this study is to determine whether adding feedback-based balance training to conventional physiotherapy improves balance and walking ability in cancer patients with CIPN. Participants will be randomly assigned to one of two groups. One group will receive conventional physiotherapy along with feedback-based balance and gait training, while the other group will receive conventional physiotherapy alone.\n\nThe intervention will be provided twice per week for four weeks. Balance, gait performance, neuropathy symptoms, and fear of falling will be assessed before and after the intervention using standardized clinical outcome measures. The findings of this study may help identify effective rehabilitation strategies to improve balance and mobility in cancer patients affected by chemotherapy-induced peripheral neuropathy.",[61],[177,350,351,352,353,354,355,356],"Balance Training","Feedback-Based Training","Gait Training","Physiotherapy","Cancer Rehabilitation","Fall Prevention","Postural Control","2026-01-18",{"date":359,"type":38},"2026-01-26",{"date":361,"type":23},"2025-12-29",{"date":363,"type":23},"2026-04-29",{"name":365,"class":98},"King Edward Medical University",{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":237,"phases":4,"briefSummary":374,"conditions":375,"keywords":376,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":392,"locationsCount":46},"100620045","use-of-pea-and-scutellaria-in-synergy-with-therapeutic-exercise-in-chemotherapy-induced-peripheral-neuropathy-cipn-a-clinical-trial-100620045","NCT07352514","Use of PEA and Scutellaria in Synergy With Therapeutic Exercise in Chemotherapy-induced Peripheral Neuropathy (CIPN): a Clinical Trial","Inclusion Criteria:\n\n* Adults aged 18 years and older.\n* Patients who have undergone chemotherapy treatment within the previous 6 months.\n* Patients treated with PEA, Scutellaria, and standardized therapeutic exercise according to the EXCAP protocol from April 2025 to September 2025.\n* Patients with a washout period from opioid-based analgesic therapy of at least 10 days or who are not receiving opioid-based analgesic therapy.\n* Patients presenting with neuropathic pain (NRS ≥ 5).\n* Patients able to provide written informed consent.\n\nExclusion Criteria:\n\n* Patients younger than 18 years.\n* Patients with hypersensitivity to PEA or any of the excipients listed in the Summary of Product Characteristics (SPC).\n* Patients with diabetic pathology.\n* Patients with severe hepatic impairment.\n* Patients with severe disabilities that compromise the execution of therapeutic exercise.",{"count":373,"type":23},40,"This study aims to find out if taking specific dietary supplements (PEA and Scutellaria) along with therapeutic exercise can help reduce nerve pain and damage caused by chemotherapy. Many cancer patients experience nerve-related side effects from chemotherapy, which can significantly impact their quality of life. The study will observe patients who use these supplements and exercises to see if they can effectively manage and improve their nerve health and reduce pain.",[29,113],[177,113,377,378,379,380,381,382,383,384,385],"Nutraceuticals","Palmitoylethanolamide","Scutellaria","Therapeutic Exercise","Cancer Patients","Pain Management","Neuropathy Treatment","Clinical Trial","Observational Case-Control Study","2026-01-13",{"date":388,"type":38},"2026-01-20",{"date":390,"type":38},"2025-03-15",{"date":223,"type":23},{"name":393,"class":98},"University of Palermo",{"id":395,"slug":396,"hasResults":12,"nctId":397,"briefTitle":398,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":12,"sex":18,"minAge":400,"maxAge":4,"enrollmentInfo":401,"targetDuration":4,"studyType":24,"phases":403,"briefSummary":404,"conditions":405,"keywords":409,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":46},"100619580","exploring-the-effects-of-magnesium-ions-on-peripheral-neuropathy-serum-magnesium-ion-concentrationsleep-quality-and-quality-of-life-in-patients-with-colorectal-cancer-receiving-chemotherapy-100619580","NCT07346469","Exploring the Effects of Magnesium Ions on Peripheral Neuropathy, Serum Magnesium Ion Concentration,Sleep Quality, and Quality of Life in Patients With Colorectal Cancer Receiving Chemotherapy.","Inclusion Criteria:\n\n* a. Patients diagnosed with colorectal cancer by pathology.\n* b. Age ≥ 20 years.\n* c. Conscious.\n* d. Able to communicate fluently in Mandarin and Taiwanese.\n* e. Patients who have received or are expected to begin chemotherapy (Oxaliplatin).\n\nExclusion Criteria:\n\n* a. ECOG (Eastern Cooperative Oncology Group) ≥2 points.\n* b. Patients receiving intravenous nutrition.\n* c. Patients with pre-existing neuropathy.\n* d. Patients with skin wounds.\n* e. Patients with implanted pacemakers.\n* f. Patients with phenylketonuria.\n* g. Patients with diarrhea.\n* h. Patients with renal insufficiency.\n* i. Patients with hypermagnesemia.\n* j. Patients allergic to any of the ingredients","20 Years",{"count":402,"type":23},75,[58],"Chemotherapy for colorectal cancer (CRC) is frequently complicated by chemotherapy-induced peripheral neuropathy (CIPN) and impaired sleep quality, significantly impacting patient quality of life. Low magnesium levels have been implicated in peripheral nerve dysfunction. This interventional study aims to investigate the effects of magnesium supplementation on serum magnesium concentration, CIPN severity, and sleep quality in CRC patients undergoing chemotherapy.\n\nStudy Design and Methods\n\nThis is a prospective, parallel-group, randomized controlled trial (RCT) utilizing a longitudinal design. Participants (CRC patients undergoing chemotherapy) will be randomly allocated to one of three groups:\n\n* Experimental Group 1: Oral magnesium (400mg) supplementation.\n* Experimental Group 2: Oral magnesium (400mg}) supplementation and magnesium solution foot baths.\n* Control Group: Standard care.\n\nMeasurements will be collected using structured questionnaires and blood samples during each chemotherapy cycle. The primary outcomes will be assessed using:\n\n* Serum Magnesium Concentration\n* CIPN Severity: Functional Assessment of Cancer Therapy\u002FGynecologic Oncology Group-neurotoxicity (FACT\u002FGOG-Ntx) scale.\n* Sleep Quality: Verran and Snyder-Halpern Sleep Scale (VSH). Primary Research Questions (Hypotheses)\n\n  1. Can the magnesium intervention (oral and\u002For foot baths) effectively increase the serum magnesium concentration in CRC patients?\n  2. Can the magnesium intervention alleviate or improve the severity of CIPN?\n  3. Can the magnesium intervention improve the sleep quality of CRC patients during chemotherapy? The intervention groups will be compared against the control group to determine if the magnesium interventions lead to superior improvement in the measured outcomes.",[406,61,407,408],"Colorectal Cancer (CRC)","Sleep Quality","Quality of Life (QOL)",[410,411,407,412],"Colorectal cancer (CRC)","Chemotherapy induced peripheral neuropathy (CIPN)","Quality of life (QOL)","2026-01-07",{"date":332,"type":38},{"date":416,"type":23},"2026-01-01",{"date":418,"type":23},"2028-12-31",{"name":420,"class":98},"Kaohsiung Medical University Chung-Ho Memorial Hospital",{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":427,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":237,"phases":4,"briefSummary":431,"conditions":432,"keywords":433,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":446},"100616345","evaluation-of-effectiveness-of-closed-loop-spinal-cord-stimulation-cl-scs-therapy-for-treatment-of-chemotherapy-induced-peripheral-neuropathy-100616345","NCT07304401","Evaluation of Effectiveness of Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy for Treatment of Chemotherapy Induced Peripheral Neuropathy","Assessment of Effectiveness of Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy on Pain Reduction and Improvement of Quality of Life in Patients With Chemotherapy Induced Peripheral Neuropathy","CIPRESS","* Subject is deemed a suitable candidate for SCS implantation and has been routinely scheduled to undergo an SCS implantation with the Evoke SCS System.\n* Subject has a minimum of leg or arm pain intensity of 5\u002F10 on the numeric rating scale (NRS) at baseline due to CIPN.\n* Patients with CIPN following chemotherapy and at least 6 months post-treatment\n* CIPN symptoms for a minimum duration of 3 months.\n* Patient deemed to be in remission per discretion of treating oncologist\n* No existing contraindications for SCS\n* Subject is ≥ 18 years old.\n* Subject is not pregnant or nursing.\n* Subject is willing and capable of giving informed consent.\n* No satisfactory treatment effect with anti-neuropathic medication or intolerable side-effects\n* No satisfactory treatment effect with minimal invasive pain treatments (including ketamine or lidocaine infusion therapy)\n\nExclusion Criteria:\n\n* Patient refusal to be included in study\n* Patients unwilling or mentally incapable to complete the study questionnaires\n* Other causes of neuropathy (for example diabetic- or small fiber neuropathy)\n* Previous treatment with SCS for CIPN\n* Presence of another pain syndrome unrelated to CIPN\n* History of lower limb amputation or ulceration\n* Body mass index (BMI) ≥ 40\n* Severe psychiatric or neurological disorders\n* Any other contra indication for locoregional anaesthesia",{"count":430,"type":23},20,"The goal of this observational study is to learn about the effectiveness of closed-loop spinal cord stimulation (CL-SCS) therapy for treatment of painful chemotherapy induced peripheral neuropathy.\n\nThe closed-loop SCS (CL-SCS) system stimulates the nerves in the spinal cord, measures their responses and automatically adjust the stimulation level accordingly in real time for each delivered pulse.",[61,113],[33,212,434,435,436,118],"Spinal Cord Stimulation","SCS","Closed-Loop","2025-12-24",{"date":439,"type":38},"2025-12-26",{"date":441,"type":23},"2025-12-01",{"date":443,"type":23},"2028-12-01",{"name":445,"class":98},"Rijnstate Hospital",5,{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":12,"sex":18,"minAge":454,"maxAge":455,"enrollmentInfo":456,"targetDuration":4,"studyType":24,"phases":458,"briefSummary":459,"conditions":460,"keywords":461,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":466,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":46},"100617504","preliminary-effectiveness-and-feasibility-of-transcutaneous-acupoints-electrical-stimulation-on-chemotherapy-induced-peripheral-neuropathy-among-children-with-acute-lymphoblastic-leukemia-100617504","NCT07319481","Preliminary Effectiveness and Feasibility of Transcutaneous Acupoints Electrical Stimulation on Chemotherapy-induced Peripheral Neuropathy Among Children With Acute Lymphoblastic Leukemia","Preliminary Effectiveness and Feasibility of Transcutaneous Acupoints Electrical Stimulation on Chemotherapy-induced Peripheral Neuropathy Among Chinese Children With Acute Lymphoblastic Leukemia: A Randomized Controlled Trial","Inclusion Criteria:\n\n* age between 10 and 17 years old\n* diagnosed with ALL\n* received neurotoxic chemotherapy\n* have developed score 9 or above CIPN symptoms according to Pediatric Chemotherapy-Induced Neuropathy (P-CIN)\n* able to communicate and read Chinese\n\nExclusion Criteria:\n\n* receiving multiple cancer treatment\n* had a diagnosis of cancer in the central nervous system cancer, cancer relapse or secondary cancer\n* having other neuromuscular disorders, for example, traumatic brain injury and cerebral palsy\n* having other systematic diseases that cause toxicity in the peripheral nervous system, such as sickle cell disease (SCD), Guillain-Barre ́ Syndrome (GBS), anterior cutaneous nerve entrapment syndrome (ACNES), obstetric brachial plexus injury (OBPI), type I diabetes mellitus, postherpetic neuralgia (PHN), peroneal nerve injury, and reflex sympathetic dystrophy (RSD)\n* acupoints areas with injuries, wounds or allodynia\n* participated in any other CIPN non-pharmacological intervention programme\n* having any impaired bone marrow suppression\n* contraindications to TEAS : such as having a pacemaker, skin infection, damage, or allergy to the electrodes\n* suffering from mental illness or using antipsychotic drugs\n* parents and children refused to give consent.","10 Years","17 Years",{"count":457,"type":23},60,[58],"The first goal of this clinical trial is to assess the feasibility of transcutaneous acupoints electrical stimulation (TAES) on children with acute lymphoblastic leukemia (ALL). The second goal of this clinical trial is to evaluate the preliminary effectiveness of TAES on subject chemotherapy induced peripheral neuropathy (CIPN) symptoms severity, physical function, psychological distress, and quality of life at postintervention and at 1-, and 3-month follow-up postintervention.\n\nThe main questions it aims to answer are:\n\n1. What is the feasibility of implementing TAES for children with ALL, as measured by the eligibility rate, consent rate, randomization rate etc.?\n2. Does TAES can improve CIPN symptoms severity, physical function, psychological distress, quality of life in children with ALL compared with sham control group?\n\nThis proposed research is designed to conduct a two-arm RCT comparing TAES to sham TAES in children with ALL. Subjects in TAES group will receive 8 weeks TAES on four acupoints. Subjects in sham control group will follow the same protocol as the TEAS treatment but with 0 mA, 0 Hz TAES. These two groups will be provided with a leaflet containing self-help materials for CIPN.",[61],[462,463,464,212],"acute lymphoblastic leukemia","transcutaneous acupoints electrical stimulation","children","2025-12-21",{"date":467,"type":38},"2026-01-06",{"date":469,"type":23},"2026-02-01",{"date":471,"type":23},"2027-01-31",{"name":473,"class":98},"The Hong Kong Polytechnic University",{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":480,"eligibilityCriteria":481,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":482,"targetDuration":4,"studyType":237,"phases":4,"briefSummary":484,"conditions":485,"keywords":486,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":494,"locationsCount":4},"100617185","assessing-functional-impairments-in-patients-with-chemotherapy-induced-peripheral-neuropathy-100617185","NCT07315334","Assessing Functional Impairments in Patients With Chemotherapy-Induced Peripheral Neuropathy","Assessing Functional Impairments in Patients With Chemotherapy-Induced Peripheral Neuropathy (CIPN)","Assess CIPN","Inclusion Criteria:\n\n\\- Male and female patients with CIPN grade ≥ 2, according to Common Terminology Criteria for Adverse Events for peripheral sensory or motor neuropathy (CTCAE) version 5\n\n\\- Age ≥ 18\n\n\\- Ongoing or completed neuropathy-inducing chemotherapy\n\n\\- Ability to stand and walk\n\n\\- Ability to fill out a questionnaire Inclusion criteria for healthy controls\n\n\\- Male and female adults (age ≥ 18)\n\n\\- Ability to stand and walk\n\n\\- Ability to fill out a questionnaire\n\nExclusion Criteria:\n\n* Pre-existing clinically manifest peripheral neuropathy prior to start of chemotherapy (e.g. caused by radiation or malignant plexopathy, lumbar or cervical radiculopathy, carpal tunnel syndrome, B12 deficiency, AIDS, monoclonal gammopathy, diabetes, heavy metal poisoning amyloidosis, syphilis, hyperthyroidism or hypothyroidism, inherited neuropathy, etc.)\n\nAcute or chronic injuries\u002F diseases of the musculoskeletal system affecting functional tests\n\n\\- Acute or chronic cardiovascular diseases affecting functional tests\n\n\\- Neurological disease affecting functional tests (for healthy controls)\n\n\\- Neurological disease other than CIPN affecting functional tests (for CIPN patients)",{"count":483,"type":23},80,"Chemotherapy-induced peripheral neuropathy (CIPN) is a severe side effect of several anti-cancer agents. Typical symptoms include tingling and hypoesthesia in the fingertips and\u002For toes, which substantially impair patients' quality of life and independence. Providing effective, evidence-based treatments for CIPN remains a major challenge in clinical practice. In a recent randomized clinical trial, our group demonstrated the effectiveness of electrotherapy in reducing both sensory and motor symptoms, as assessed by the EORTC-QLQ-CIPN20 questionnaire and CIPN grading according to CTCAE. However, these findings were based exclusively on patients' subjective self-reports (EORTC QLQ CIPN 20 and C-30). To more objectively evaluate treatment success, functional assessments that capture impairments in daily activities are needed.\n\nIn this cross-sectional comparison, we will conduct comprehensive functional assessments and correlate the results with patients' subjective ratings using the EORTC-QLQ-CIPN20, QLQ-C30, and CTCAE v5.0 grading. In addition, data from matched healthy controls will be collected and compared with those of CIPN patients. The findings of this study will contribute to the development of objective measures of functional limitations caused by CIPN and provide a valuable complement to patient-reported outcome obtained through validated questionnaires.",[61],[487],"CIPN, EORTC CIPN20, gait , balance, functional assessment, 9 hole peg test,","2025-12-18",{"date":490,"type":38},"2026-01-02",{"date":492,"type":23},"2026-01-15",{"date":281,"type":23},{"name":495,"class":98},"Paracelsus Medical University",{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":4,"eligibilityCriteria":502,"healthyVolunteers":12,"sex":18,"minAge":503,"maxAge":455,"enrollmentInfo":504,"targetDuration":4,"studyType":24,"phases":506,"briefSummary":507,"conditions":508,"keywords":509,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":46},"100614455","improving-chemotherapy-induced-peripheral-neuropathy-in-children-with-leukemia-a-study-of-transcutaneous-acupoints-electrical-stimulation-and-auricular-acupressure-interventions-100614455","NCT07279818","Improving Chemotherapy Induced Peripheral Neuropathy in Children With Leukemia: A Study of Transcutaneous Acupoints Electrical Stimulation and Auricular Acupressure Interventions","Effectiveness of Transcutaneous Acupoints Electrical Stimulation and Auricular Acupressure on Chemotherapy Induced Peripheral Neuropathy in Children With Leukemia: a Single Blind Randomized Controlled Study","Inclusion Criteria:\n\n* age between 8 and 17 years old\n* diagnosed with leukemia\n* received neurotoxic chemotherapy\n* have developed score 9 or above CIPN symptoms according to Pediatric Chemotherapy-Induced Neuropathy (P-CIN)\n* able to communicate and read Chinese\n\nExclusion Criteria:\n\n* receiving multiple cancer treatment\n* had a diagnosis of cancer in the central nervous system cancer, cancer relapse or secondary cancer\n* having other neuromuscular disorders, for example, traumatic brain injury and cerebral palsy\n* having other systematic diseases that cause toxicity in the peripheral nervous system, such as sickle cell disease (SCD), Guillain-Barre ́ Syndrome (GBS), anterior cutaneous nerve entrapment syndrome (ACNES), obstetric brachial plexus injury (OBPI), type I diabetes mellitus, postherpetic neuralgia (PHN), peroneal nerve injury, and reflex sympathetic dystrophy (RSD)\n* acupoints areas with injuries, wounds or allodynia\n* participated in any other CIPN non-pharmacological intervention programme\n* having any impaired bone marrow suppression, liver or renal function\n* contraindications to TEAS or auricular acupressure: such as having a pacemaker, skin infection, damage, or allergy to the electrodes\n* suffering from mental illness or using antipsychotic drugs\n* parents and children refused to give consent.","8 Years",{"count":505,"type":23},132,[58],"The goal of this clinical trial is to compare the effectiveness of Transcutaneous Acupoints Electrical Stimulation (TAES) and Auricular Acupressure (AA) on subject CIPN symptoms, sensory function, motor and physical function, psychological, physical symptoms and quality of life outcomes in Children with Leukemia.\n\nThe main questions it aims to answer are:\n\n1. Does TAES and AA can improve CIPN symptoms, sensory function, motor and physical function, psychological, physical symptoms and quality of life outcomes in children with Leukemia compared with self-management control group?\n2. Does TAES yield improvements in CIPN symptoms, sensory function, motor and physical function, psychological, physical symptoms and quality of life outcomes that are comparable to those achieved through AA in children with leukemia?\n\nThis proposed research is designed to conduct a three-arm RCT comparing TAES, AA to usual care in children with leukemia.\n\nSubjects in TAES group will receive 8 weeks TAES on four acupoints. Subjects in AA group will receive 8 weeks on four acupoints. Subjects in self-management control group will receive usual care they will receive from the hospital. These three groups will be provided with a leaflet containing self-help materials for CIPN.",[61],[510,511,512,513,464],"Transcutaneous Acupoints Electrical Stimulation","Auricular Acupressure","chemotherapy induced peripheral neuropathy","Leukemia","2025-12-10",{"date":516,"type":38},"2025-12-12",{"date":518,"type":23},"2025-12-08",{"date":520,"type":23},"2026-09-30",{"name":473,"class":98},{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":528,"eligibilityCriteria":529,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":530,"targetDuration":4,"studyType":24,"phases":532,"briefSummary":533,"conditions":534,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":4},"100417427","phase-3-stibium-metallicum-praeparatum-6x-versus-placebo-in-the-prevention-of-paclitaxel-induced-peripheral-neurotoxicity-100417427","NCT04715542","Stibium Metallicum Praeparatum 6x Versus Placebo in the Prevention of Paclitaxel-induced Peripheral Neurotoxicity","Subcutaneous Stibium Metallicum Praeparatum 6x Versus Placebo in the PRevention Of PaclitaxEL-induced Peripheral NeurOTOXicity: the PROPEL NO TOX Randomized Controlled Trial","PROPEL NO TOX","Inclusion criteria\n\n* Age ≥ 18\n* Individuals with early breast cancer, stage I to IIIC, who are about to receive a paclitaxel-based neo-adjuvant or adjuvant chemotherapy, with a planned dosing regimen of 80 mg of paclitaxel per square meter of body surface by intravenous infusion weekly for 12 doses.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Ability to provide informed consent as documented by signature\n* Ability to read, write, and speak German\n\nExclusion Criteria:\n\n* Patients with pre-existing neuropathy\n* Prior chemotherapy with taxanes or other neurotoxic agents\n* Concomitant medications that are known to cause neuropathy\n* Pregnancy or lactation\n* Lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.\n* Patients with psychiatric, addictive or any disorder that prevents the patient from adhering to the protocol requirements, in the opinion of the investigator\n* Lactose intolerance or glucose-galactose-malabsorption, as well as any other contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product\n* Life expectancy \\\u003C 3 months",{"count":531,"type":23},120,[82],"Chemotherapy induced peripheral neuropathy (CIPN) is one of the most limiting side effects of chemotherapy and often leads to adaptations in the protocol of the chemotherapy including dose reduction or even discontinuation of treatment. In general, the symptoms of CIPN are sensory, often distributed in a \"stocking and glove\" manner, and include pain, tingling, and numbness. CIPN has a marked negative influence on quality of life of patients and their families. It may result in serious limitations in daily functioning and affect the enjoyment, social relationships, and ability to perform work. Current management of CIPN (i.e. prevention and treatment) includes dose reduction or delay of chemotherapy cycles and treatment discontinuation. Unfortunately, this reduces the chance of an effective cancer treatment. Current guidelines of the American Society of Clinical Oncology (ASCO) on the Prevention and Management of Chemotherapy-Induced Peripheral Neuropathy do not conclusively recommend any agent for the prevention of CIPN. Due to the scarcity of drugs that are effective for preventing and treating CIPN, the distress of patients who suffer from CIPN, and the major societal and economic costs, new approaches and effective treatment strategies are required.\n\nThe proposed trial is a parallel, double blind, placebo controlled, randomised, phase III superiority trial, aiming to determine whether treatment with SMP prevents incidence of or reduces the severity symptoms of paclitaxel-induced peripheral neuropathy, as compared to placebo.",[61],"2025-11-20",{"date":537,"type":38},"2025-11-25",{"date":539,"type":23},"2026-08",{"date":541,"type":23},"2029-08",{"name":543,"class":98},"University of Bern",{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":4,"eligibilityCriteria":550,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":551,"targetDuration":4,"studyType":24,"phases":553,"briefSummary":554,"conditions":555,"keywords":557,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":46},"100606001","simple-surgical-glove-compression-to-prevent-chemotherapy-induced-peripheral-neuropathy-100606001","NCT07169864","Simple Surgical Glove Compression to Prevent Chemotherapy-Induced Peripheral Neuropathy","An Exploratory Self-Controlled Study on the Preventive Effect of the Simple Surgical Glove Compression Technique Against Chemotherapy-Induced Peripheral Neuropathy","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Histologically confirmed primary invasive breast cancer;\n* Planned to receive ≥ 8 weeks of weekly neoadjuvant chemotherapy (utidelone plus cisplatin);\n* ECOG performance status: 0-1;\n\nExclusion Criteria:\n\n* Distant metastasis;\n* Presence of sensory or motor neurological disorders, or symptoms related to peripheral neuropathy with CTCAE grade ≥ 2, or currently receiving medication for peripheral neuropathy;\n* Conditions affecting limb function;\n* Known allergy to glove materials (e.g., latex)",{"count":552,"type":23},44,[58],"To evaluate the preventive efficacy of a simple surgical glove compression technique in reducing the incidence and severity of Chemotherapy Induced Peripheral Neuropathy among patients receiving chemotherapy.",[180,61,556],"Neoadjuvant Therapy",[558,33,559],"Utidelone","Neoadjuvant chemotherapy","2025-09-11",{"date":562,"type":38},"2025-09-12",{"date":564,"type":23},"2025-09-15",{"date":566,"type":23},"2027-12-31",{"name":568,"class":98},"Jinsong Lu",{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":4,"eligibilityCriteria":575,"healthyVolunteers":12,"sex":168,"minAge":19,"maxAge":576,"enrollmentInfo":577,"targetDuration":4,"studyType":24,"phases":579,"briefSummary":580,"conditions":581,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":582,"startDateStruct":584,"completionDateStruct":586,"leadSponsor":587,"locationsCount":46},"100592521","phase-3-gm1-prophylaxis-for-nab-paclitaxel-associated-chemotherapy-induced-peripheral-neuropathy-cipn-in-patients-with-breast-cancer-100592521","NCT06994507","GM1 Prophylaxis for Nab-paclitaxel-associated Chemotherapy-induced Peripheral Neuropathy (CIPN) in Patients With Breast Cancer","A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 3 Trial of GM1 Prophylaxis for Nab-paclitaxel-associated Chemotherapy-induced Peripheral Neuropathy (CIPN) in Patients With Breast Cancer（Gypsophila )","Inclusion Criteria:\n\n* Voluntarily sign the informed consent form;\n* Age: 18 to 75 years old;\n* Female patients with breast cancer confirmed byhistological and\u002For cytological diagnostic basis for breast cancer and are intended to receive adjuvant\u002Fneoadjuvant therapy with Albumin paclitaxel regimens;\n* ECOG: 0-1\n* Adequate organ function level\n* Glycated hemoglobin (HbA1c) \\\u003C 7.0%;\n* For women of childbearing potential: use effective contraceptive measures for contraception from the date of signing the informed consent form until 30 days after the last use of the investigatory drug.\n* Patients can accurately record or express the occurrence and severity of peripheral neuropathy through questionnaires.\n\nExclusion Criteria:\n\n* Grade ≥1 peripheral neuropathy (CTCAE grade ≥1) or any of the first 4 items of FACT\u002FGOG-Ntx ≥1;\n* There are risk factors for peripheral neuropathy (excluding peripheral neuropathy caused by chemotherapy).\n* History of another malignant tumors (except breast cancer)\n* Symptoms such as muscle pain in the limbs that interfere with the evaluate of peripheral neuropathy;\n* Uncontrolled cardiovascular and cerebrovascular system diseases or hypertension\n* Active infections that require systematic treatment, including bacteria, fungi or viruses, within one week before first study drug use; Or infectious diarrhea occurred within 4 weeks before the first study drug use;\n* Hereditary abnormal glycolipid metabolism, HIV infection or known Acquired Immune Deficiency Syndrome (AIDS); Positive syphilis antibody, active hepatitis B, active hepatitis C","75 Years",{"count":578,"type":23},352,[82],"This study is a randomized, double-blind, multicenter, placebo-controlled phase III clinical trial, aiming to evaluate the efficacy and safety of GM1 in preventing chemotherapy-induced peripheral neuropathy in breast cancer patients treated with Albumin-paclitaxel chemotherapy regimen.",[29],{"date":583,"type":38},"2025-08-06",{"date":585,"type":38},"2025-08-01",{"date":225,"type":23},{"name":588,"class":45},"Qilu Pharmaceutical Co., Ltd.",{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":593,"acronym":594,"eligibilityCriteria":595,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":596,"targetDuration":4,"studyType":24,"phases":598,"briefSummary":599,"conditions":600,"keywords":601,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":604,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":612},"100590066","the-effect-of-personalized-exercise-interventions-for-the-prevention-of-chemotherapy-induced-peripheral-neuropathy-100590066","NCT06962579","The Effect of Personalized Exercise Interventions for the Prevention of Chemotherapy-induced Peripheral Neuropathy","CIPN-EX","Inclusion Criteria:\n\n* age above 18 years\n* a primary diagnosis of breast, gynaecological or colon cancer, without distant metastasis\n* been chemotherapy naïve\n* been scheduled for at least 12 weeks of taxane- or platinum-based chemotherapy without other neurotoxic chemotherapy\n\nExclusion Criteria:\n\n* life expectancy of less than six months according to the patient's oncologist or designee\n* advanced stage of disease\n* having a known current neuropathy\n* having cognitive or physical limitations that contraindicate participation in a low- to moderate intensity home-based walking and progressive resistance program (determined by the patient's oncologist)\n* not able to read and understand Dutch\n* not able to provide informed consent\n* not able to participate during the entire study period\n* pregnancy",{"count":597,"type":23},206,[58],"Chemotherapy-induced peripheral neuropathy (CIPN) is a debilitating and common side effect of neurotoxic cancer treatment. The most frequent symptoms include sensory disturbances and weakness in the hands and\u002For feet. CIPN can interfere with both daily activities and cancer treatment itself. Although there is proof of concept for physical activity as a preventive measure for CIPN, physical activity is currently not included in the international evidence-based guideline for the prevention of CIPN due to the need of larger sample-sized definitive studies. The aim of this project is, on the one hand, to investigate the preventive effect of an exercise program based on international physical activity guidelines on CIPN symptoms in patients with breast or colorectal cancer undergoing taxane- or platinum-based chemotherapy. On the other hand, the study will also explore how patients and healthcare professionals experience the implementation of physical activity during this phase of therapy. A prospective randomized controlled trial will be conducted, with CIPN symptoms as the primary outcome measure.",[61],[512,602],"exercise","2025-07-03",{"date":605,"type":38},"2025-07-09",{"date":607,"type":38},"2025-06-05",{"date":609,"type":23},"2028-11-01",{"name":611,"class":98},"Universiteit Antwerpen",2,{"id":614,"slug":615,"hasResults":12,"nctId":616,"briefTitle":617,"officialTitle":618,"acronym":4,"eligibilityCriteria":619,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":620,"targetDuration":4,"studyType":24,"phases":622,"briefSummary":623,"conditions":624,"keywords":626,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":629,"lastUpdatePostDateStruct":630,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":46},"100582084","effect-of-adding-electroacupuncture-to-anti-cancer-therapy-induced-peripheral-neuropathy-100582084","NCT06858709","Effect of Adding Electroacupuncture to Anti-cancer Therapy-induced Peripheral Neuropathy","Effect of Adding Electroacupuncture Combined With Standard Anti Chemotherapy-induced Peripheral Neuropathy Drugs to Anti-cancer Therapy-induced Peripheral Neuropathy: a Randomized Multicentered Clinical Trial.","Inclusion Criteria:\n\n* 18 years of age or older, of any nationality.\n* Patients diagnosed with malignant tumor.\n* Eligible patients will report altered sensations and\u002For pain and\u002For other neurological symptoms, with a grade between 2-3 for chemotherapy-induced peripheral neuropathy on the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events-version 5.0 (NCI-CTCAE.v-5.0).\n* Predicted life expectancy of ≥3 months.\n* Intact skin without any breaches or purulent discharge.\n* Written informed consent by the patient before enrolment Patients must be able to comply with the study protocol, which includes attending the treatment sessions on time and completing the study questionnaires in accordance with the study protocol.\n\nExclusion Criteria:\n\n* History of pre-existing peripheral neuropathy before chemotherapy, including alcoholism, vitamin B deficiency, diabetes, HIV, congenital neuropathy, and toxic neuropathy.\n* Patients with skin damage, pus or scar at the acupuncture stimulation area.\n* Patients who are pregnant or breastfeeding.\n* Significant mental conditions.\n* Patients not fulfilling the inclusion criteria.\n* Patients receiving other acupuncture treatments during the trial.",{"count":621,"type":23},150,[58],"This study is being done to evaluate the potential benefits of using electroacupuncture to reduce the severity of chemotherapy-induced peripheral neuropathy for patients with peripheral neuropathy after chemotherapy.",[29,625],"Cancer",[627,628],"Chemotherapy-induced peripheral neuropathy (CIPN)","electroacupuncture treatment","2025-04-15",{"date":631,"type":38},"2025-04-20",{"date":633,"type":38},"2025-03-20",{"date":635,"type":23},"2027-03-30",{"name":637,"class":98},"Zhongnan Hospital",{"id":639,"slug":640,"hasResults":12,"nctId":641,"briefTitle":642,"officialTitle":643,"acronym":4,"eligibilityCriteria":644,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":576,"enrollmentInfo":645,"targetDuration":4,"studyType":24,"phases":647,"briefSummary":648,"conditions":649,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":650,"lastUpdatePostDateStruct":651,"startDateStruct":653,"completionDateStruct":654,"leadSponsor":655,"locationsCount":612},"100582244","phase-1-ak135-in-patients-with-chemotherapy-induced-peripheral-neuropathy-cipn-100582244","NCT06860789","AK135 in Patients With Chemotherapy-Induced Peripheral Neuropathy (CIPN)","A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AK135 for the Treatment of Chemotherapy-Induced Peripheral Neuropathy (CIPN) in Patients With Malignant Tumors","Inclusion Criteria:\n\n1. Written and signed informed consent.\n2. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.\n3. Life expectancy ≥ 3 months.\n4. Histologically or cytologically documented malignant tumor.\n5. Previous anti-tumor therapy causing peripheral neurotoxicity that has been discontinued for at least 1 month before enrollment.\n6. Diagnosed with Chemotherapy-Induced Peripheral Neuropathy (CIPN) by an oncologist or neurologist, with at least grade 2 NCI Common Terminology Criteria for Adverse Events.\n7. Must have pain and\u002For numbness due to chemotherapy-induced peripheral neuropathy (CIPN) symptoms.\n8. Adequate organ function.\n\nExclusion Criteria:\n\n1. Pharmacologic or non-pharmacologic treatment for CIPN within 2 weeks before the first dose of AK135.\n2. Concurrent and\u002For scheduled to start any anti-tumor treatment that may cause Chemotherapy-Induced Peripheral Neuropathy (CIPN) within 3 months after the first dose of AK135.\n3. Concurrent and\u002For scheduled to start any anti-tumor treatment that may cause hand-foot skin reaction within 3 months after the first dose of AK135.\n4. Presence with other illnesses may result in peripheral neuropathy including, autoimmune diseases, diabetes and metabolic syndrome, peripheral vascular disease, infections, nerve injury or compression, vitamin deficiencies, and so on.\n5. Skin lesions may affect the assessment of peripheral neuropathy.\n6. Unresolved toxicities from prior anti-cancer therapy within 2 weeks before the first dose of AK135, defined as not having resolved to NCI CTCAE v5.0 Grade 0 or 1, or levels specified in the inclusion\u002Fexclusion criteria, except for alopecia, and neuropathy.\n7. Known allergy or reaction to any component of the AK135 formulation. History of severe hypersensitivity reactions to other mAbs.",{"count":646,"type":23},85,[26],"A Phase I open label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of AK135 for the treatment of chemotherapy-induced peripheral neuropathy in patients with malignant tumor",[29],"2025-02-28",{"date":652,"type":38},"2025-03-06",{"date":650,"type":23},{"date":566,"type":23},{"name":656,"class":45},"Akeso",{"id":658,"slug":659,"hasResults":12,"nctId":660,"briefTitle":661,"officialTitle":662,"acronym":663,"eligibilityCriteria":664,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":665,"targetDuration":4,"studyType":24,"phases":667,"briefSummary":668,"conditions":669,"keywords":673,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":684,"lastUpdatePostDateStruct":685,"startDateStruct":687,"completionDateStruct":689,"leadSponsor":691,"locationsCount":46},"100577519","phase-2-gut-microbiome-profiles-in-patients-with-chemotherapy-induced-neuropathy-in-the-rct-ozoparqt-nct06706544-100577519","NCT06799351","Gut Microbiome Profiles in Patients with Chemotherapy-induced Neuropathy in the RCT OzoParQT (NCT06706544).","Evaluation of the Gut Microbiome Profiles in Patients with Chemotherapy-induced Peripheral Neuropathy Treated in the Randomized Clinical Trial with Ozone OzoParQT (NCT06706544).","OzoParQTmicrob","Inclusion Criteria:\n\n* 0\\. Patients who agree to participate in the randomized clinical trial OzoParQT, and who also agree to participate in this study of gut microbiota by providing stool samples.\n* 1\\. Adults \\> = 18 years old.\n* 2\\. Previous treatment with any chemotherapy because of any tumor.\n* 3\\. Clinical diagnosis of paresthesia (numbness, tingling) secondary to CIPN, with toxicity Grade \\> = 2 (according to the Common Toxicity Criteria for Adverse Events (CTCAE) from the National Cancer Institute of EEUU, v.5.0) for \\> = 3 months.\n* 4\\. Without neurotoxic chemotherapy \\> = 3 months.\n* 5\\. Cancer disease is stable or in remission.\n* 6\\. Life expectancy \\> = 6 months.\n* 7\\. Before enrollment, women of childbearing potential should obtain a negative result in the serum or urine pregnancy test at the screening visit and accept the use of appropriate contraceptive methods at least from 14 days before the first ozone therapy session up to 14 days after the last one.\n* 8\\. To sign and date the specific informed consent of both studies (OzoParQT and OzoParQTmicrob)\n\nExclusion Criteria:\n\n* 1\\. Age \\\u003C 18 years.\n* 2\\. A woman who is lactating, pregnant, suspected of being pregnant, or a woman of childbearing potential who does not use adequate contraceptive methods.\n* 3\\. Suspected symptoms are due to diabetic or compressive neuropathy.\n* 4\\. Severe psychiatric disorders.\n* 5\\. Inability to complete the quality of life questionnaires.\n* 6\\. Elevation above 5 times the maximum limit of normal creatinine.\n* 7\\. Patient who is hemodynamic or clinically unstable or who requires urgent or short-term interventional measures.\n* 8\\. Neoplasia in progression requiring recent initiation of systemic treatment or maintenance with neurotoxic chemotherapy.\n* 9\\. Life expectancy (for any reason) \\\u003C 6 months.\n* 10\\. Known allergy to ozone, known glucose 6 phosphate dehydrogenase (G6PD) deficiency, or hemochromatosis.\n* 11\\. Contraindications or impossibility for rectal ozone treatment or to attend regularly to the treatment.\n* 12\\. Not meeting each and every one of the inclusion criteria",{"count":666,"type":23},42,[141,82],"Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating side effect of chemotherapy (CT), often requiring dose reductions or treatment interruptions, which can compromise efficacy of the planned CT (limiting its efficacy). Additionally, CIPN usually decreases patients' quality of life.\n\nUnfortunately, effective treatments for CIPN are limited. Emerging evidence suggests potential benefits of rectal ozone therapy and points to a possible role of the gut microbiome in CIPN development and treatment response.\n\nThis observational study, ancillary to the randomized clinical trial (RCT) OzoParQT (NCT06706544), investigates the relationship between gut microbiome composition and CIPN severity in patients receiving rectal ozone therapy.\n\nPrimary Objectives:\n\nTo evaluate if gut microbiome profiles differ between patients:\n\n1. with and without symptomatic improvement of CIPN.\n2. receiving rectal ozone therapy and those receiving placebo.\n\nSecondary Objectives:\n\nTo evaluate the relationship between gut microbiome composition and:\n\n1. Health-related quality of life,\n2. Anxiety and depression,\n3. Biochemical markers of oxidative stress and inflammation.\n\nMain Trial Endpoints.\n\nChanges from baseline at the end of ozone therapy (week 16) in:\n\n* Gut microbiome profile\n* Patient-reported numbness and tingling\n* Neuropathy severity (QLQ-CIPN20 scale)\n* Paresthesia toxicity grade (CTCAE v.5.0)\n\nSecondary Trial Endpoints.\n\nChanges from baseline at the end of ozone therapy (week 16) in:\n\n* Patient-reported quality of life (EQ-5D-5L questionnaire)\n* Quality of life (QLQ-C30 questionnaire)\n* Anxiety and depression levels (HADS questionnaire)\n* Biochemical markers of oxidative stress\n* Biochemical markers of inflammation\n\nTrial Design:\n\nThis observational study will analyze data from patients enrolled in the randomized, triple-blind, placebo-controlled OzoParQT clinical trial (NCT06706544).\n\nTrial Population in the OzoParQT trial (NCT06706544):\n\nAdults (≥18 years) with any tumor type, experiencing CIPN-related paresthesias (numbness and\u002For tingling), with a toxicity grade ≥ 2 according to the Common Terminology Criteria for Adverse Events (CTCAE v.5.0) for ≥ 3 months.\n\nIntervention in the OzoParQT trial (NCT06706544).\n\nAll patients will receive standard care for their CIPN symptoms plus 40 sessions of rectal insufflation of an O3\u002FO2 gas mixture over 16 weeks:\n\n* Ozone group: O3\u002FO2 concentration increasing from 10 to 30 µg\u002FmL\n* Control-placebo group: O2 only (0 µg\u002FmL O3)\n\nStudy Duration:\n\nEach patient will participate in this study (OzoParQTmicrob) for 16 weeks, concurrent with the ozone therapy intervention. The total planned project duration is 60 months.",[61,670,671,672],"Paresthesia","Numbness","Tingling",[212,674,675,676,677,678,679,680,681,682,683],"paresthesia","numbness and tingling","side effect of cancer treatment","toxicity of chemotherapy","ozone therapy","quality of life","anxiety","depression","oxidative stress","gut microbiota","2025-02-10",{"date":686,"type":38},"2025-02-12",{"date":688,"type":38},"2025-02-07",{"date":690,"type":23},"2030-03-31",{"name":692,"class":98},"Bernardino Clavo, MD, PhD"]