[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cipn---chemotherapy-induced-peripheral-neuropathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cipn---chemotherapy-induced-peripheral-neuropathy":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,43,68,93,122,156,181,210,233],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100609814","scrambler-therapy-for-chemotherapy-induced-peripheral-neuropathy-100609814",false,"NCT07219472","Scrambler Therapy for Chemotherapy-Induced Peripheral Neuropathy","A Randomized, Single-Blind, Sham-Controlled Study of Scrambler Therapy for Chemotherapy-Induced Peripheral Neuropathy","Inclusion Criteria:\n\n* Adults with CIPN-related pain for at least three months duration, and for which the participant wants intervention\n* At least three months from the last dose of neurotoxic cancer-directed drug\n* No plan (at the time of study enrollment) for additional neurotoxic cancer-directed therapies for at least five months after trial enrollment\n* Pain rated ≥ four out of 10 in severity (0-10 pain scale) during the seven days prior to enrollment\n* \\> six-month life expectancy\n* Able to complete questionnaires by themselves or with assistance\n* Able to provide informed written consent\n* ECOG Performance Status score ≥ two\n\nExclusion Criteria:\n\n* Pregnant or nursing\n* An operational implanted drug delivery system, implanted electronic medical device, life supporting medical device, and\u002For medical monitoring device\n* History of myocardial infarction or ischemic heart disease within six months of trial enrollment\n* History of epilepsy, brain damage resulting in seizure activity, or use of anticonvulsants for seizure\n* Skin conditions such as open sores that will prevent proper application of electrodes\n* Unwillingness or inability to wean and discontinue gabapentin or pregabalin prior to the start of ST\n* History of symptomatic peripheral neuropathy prior to receiving neurotoxic chemotherapy\n* Prior treatment with Scrambler Therapy","ALL","18 Years",{"count":19,"type":20},90,"ESTIMATED","INTERVENTIONAL",[23],"NA","This research study is for people who have a condition called chemotherapy-induced peripheral neuropathy (CIPN). This condition develops as a result of receiving medication(s) to treat cancer, particularly chemotherapy. CIPN is characterized by pain, numbness, tingling or burning sensations, typically in the hands and feet of people. These symptoms can lead to physical suffering, limited ability to perform daily activities, and low quality of life. One of the ways to treat CIPN is using a device called Scrambler Therapy. Scrambler Therapy was approved by the Food and Drug Administration (FDA) in 2009 as a treatment for CIPN. The treatment involves electrical signals passing through wires attached to parts of the body via adhesive tabs near where symptoms of CIPN are experienced. A standard treatment course consists of 10 daily sessions lasting about one hour each. The purpose of this study is to determine the effect of a 10-day course of Scrambler Therapy on symptoms of chemotherapy-induced peripheral neuropathy, day-to-day activities, overall quality of life, and use of pain medications. Participants will be randomly assigned to one of two groups. One group will receive Scrambler Therapy. The other group will not receive it. Participants will not know which group they were in until after treatment has completed. Participants in the group who did not receive Scrambler Therapy will have the opportunity to receive it after one month. Participants will be in this research study about 12 to 14 months.",[26,27],"Chemotherapy-induced Peripheral Neuropathy","CIPN - Chemotherapy-Induced Peripheral Neuropathy",[29],"Scrambler therapy","RECRUITING","2026-06-03",{"date":33,"type":34},"2026-06-04","ACTUAL",{"date":36,"type":34},"2026-03-27",{"date":38,"type":20},"2027-12",{"name":40,"class":41},"Case Comprehensive Cancer Center","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":42},"100640423","phase-1-safety-and-efficacy-of-jmkx000189-for-chemotherapy-induced-peripheral-neuropathy-100640423","NCT07601386","Safety and Efficacy of JMKX000189 for Chemotherapy-Induced Peripheral Neuropathy","A Phase Ib Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of JMKX000189 Tablets in Patients With Chemotherapy-Induced Peripheral Neuropathy","Inclusion Criteria:\n\n* Aged 18 to 75 years (inclusive), male or female.\n* Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2.\n* Life expectancy of ≥ 3 months.\n* Histologically or cytologically confirmed malignant solid tumors.\n* Investigator-confirmed diagnosis of CIPN accompanied with chemotherapy.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Presence of any type of peripheral neuropathy other than CIPN (e.g., diabetic, paraneoplastic, or nutritional).\n* Toxicities from prior anti-tumor therapy (excluding CIPN) \\> CTCAE Grade 1 within 2 weeks of first dose (excluding alopecia, skin pigmentation, stable hypothyroidism, or chronic events).\n* Participants with any of the following cardiovascular diseases or medical history:\n\n  1. Ischemic heart disease or myocardial infarction, unstable angina, coronary artery spasm, congestive heart failure (NYHA Class III-IV), cardiac arrest, stroke, or transient ischemic attack within 6 months;\n  2. Other clinically significant cardiac disorders per investigator's judgment.\n* Presence of active systemic infections.\n* History of or active primary\u002Fsecondary immunodeficiency.\n* Participation in an interventional clinical trial within 1 month prior to screening.\n* Hypersensitivity to any component of the study drug (and its excipients).\n* Any condition deemed by the investigator to pose excessive risk, confound results, or interfere with compliance.","75 Years",{"count":52,"type":20},18,[54],"PHASE1","This Phase Ib clinical trial aims to evaluate the safety, tolerability, and preliminary efficacy of JMKX000189 tablets in participants with chemotherapy-induced peripheral neuropathy (CIPN).",[27],"NOT_YET_RECRUITING","2026-05-15",{"date":60,"type":34},"2026-05-22",{"date":62,"type":20},"2026-05-10",{"date":64,"type":20},"2027-06-20",{"name":66,"class":67},"Shanghai Jeyou Pharmaceutical Co., Ltd.","INDUSTRY",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":42},"100597923","cryocompression-for-cipn-100597923","NCT07064798","Cryocompression for CIPN","Evaluating the Use of Limb Cryocompression to Reduce Taxane-induced Peripheral Neuropathy","Inclusion Criteria:\n\n* Adults \\> 18 years of age\n* Gynecologic or breast malignancy\n* Starting 1st cycle of treatment with chemotherapy regimens:\n\n  * Weekly paclitaxel x 12 or weekly paclitaxel\u002Fcarboplatin x 12, Q2 weeks paclitaxel X4 (preceded by doxorubicin\u002Fcyclophosphamide). (Breast Oncology)\n  * Q3 weeks paclitaxel\u002Fcarboplatin X 6-8 (GYN)\n* Receiving treatment on the main campus of DFCI (these patients are currently seen on Yawkey 9 and 10 and at Chestnut Hill)\n* Able to complete questionnaires in English or Spanish\n\nExclusion Criteria:\n\n* Previous exposure to neurotoxic chemotherapy\n* Pre-existing neuropathy\n* History of Raynaud's phenomenon, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, post-traumatic cold dystrophy, peripheral arterial ischemia, or sickle cell disease\n* Undergoing desensitization\n* Lymphedema in the limb where the device would be applied\n* Open skin wounds or ulcers of the limbs where the device would be applied",{"count":76,"type":20},50,[23],"This study aims to evaluate the effectiveness, tolerability, and safety of using cooling therapy and pressure (cryocompression) to reduce peripheral neuropathy, a condition affecting the nerves supplying the arms and legs (limbs) resulting in possible numbness, pain, and\u002For loss of motor function, that may occur as a result of taxane-based chemotherapy.\n\nThe name of the device used in this research study is:\n\n-Paxman Limb Cryocompression System (PLCS)",[26,80,27],"Taxane-Induced Peripheral Neuropathy",[82,26,80,83],"Peripheral Neuropathy","CIPN","2026-04-14",{"date":86,"type":34},"2026-04-15",{"date":88,"type":34},"2025-10-22",{"date":90,"type":20},"2027-08",{"name":92,"class":41},"Dana-Farber Cancer Institute",{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":100,"minAge":17,"maxAge":50,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":42},"100624479","phase-2-efficacy-and-safety-of-hyperbaric-oxygen-therapy-in-improving-nab-paclitaxel-induced-peripheral-neuropathy-100624479","NCT07410169","Efficacy and Safety of Hyperbaric Oxygen Therapy in Improving Nab-paclitaxel-Induced Peripheral Neuropathy","Efficacy and Safety of Hyperbaric Oxygen Therapy in Improving Nab-paclitaxel-Induced Peripheral Neuropathy: A Randomized Clinical Trial","Inclusion Criteria:\n\n1. aged ≥ 18 years and ≤ 75 years, female\n2. early-stage breast cancer or locally advanced breast cancer\n3. Patients who have completed adjuvant or neoadjuvant chemotherapy with nab-paclitaxel\n4. The patient developed nab-paclitaxel induced peripheral neuropathy (Nab-PIPN), as defined by meeting any of the following criteria: Patient Neurotoxicity Questionnaire (PNQ) score ≥ Grade B, NCI-CTCAE (sensory and motor neuropathy) grade ≥ 1, or neuropathic pain score ≥ 4\u002F10.\n5. The patient voluntarily participated in this study, provided written informed consent, and agreed to cooperate with follow-up assessments.\n\nExclusion Criteria:\n\n1. Patients who have previously taken drugs that may affect the evaluation of Nab-PIPN symptoms, such as duloxetine, venlafaxine, gabapentin, pregabalin, and amitriptyline.\n2. Patients with any other pathological conditions or diseases that could affect Nab-PIPN assessment, including alcoholic peripheral neuropathy, uremic peripheral neuropathy, diabetic peripheral neuropathy, thiamine deficiency-related peripheral neuropathy, and chronic axonal peripheral neuropathy of unknown etiology.\n3. Patients who have contraindications for hyperbaric oxygen therapy, including pulmonary disorders (severe chronic obstructive pulmonary disease, bullous lung disease, acute or chronic pulmonary infection, uncontrolled asthma, untreated pneumothorax), history of previous middle ear surgery, middle ear diseases (eustachian tube dysfunction, recurrent vertigo), and ocular conditions (retinal detachment).\n4. Patients with any disease history that may affect compliance, including severe mental disorders, cognitive impairment, substance abuse or addiction.\n5. Karnofsky Performance Status score \\\u003C 80\n6. Patients with any other conditions that the investigator deems unsuitable for participation in the study.","FEMALE",{"count":102,"type":20},160,[104,105],"PHASE2","PHASE3","The goal of this research is to assess whether hyperbaric oxygen therapy can alleviate the symptoms of Nab-paclitaxel-induced peripheral neuropathy and improve patient-reported quality of life.",[108,27,109],"Breast Cancer","Paclitaxel-induced Peripheral Neuropathy",[108,111,112],"paclitaxel-Induced Peripheral Neuropathy","Hyperbaric Oxygen Therapy","2026-02-07",{"date":115,"type":34},"2026-02-13",{"date":117,"type":20},"2026-01-31",{"date":119,"type":20},"2027-12-31",{"name":121,"class":41},"Guangdong Provincial People's Hospital",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":130,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":131,"targetDuration":4,"studyType":133,"phases":4,"briefSummary":134,"conditions":135,"keywords":138,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":42},"100621214","the-influence-of-chemotherapy-on-position-sense-100621214","NCT07367711","The Influence of Chemotherapy on Position Sense","Multifaced Approach of Assessing Upper Extremity Proprioception in Breast Cancer Patients With Chemotherapy-Induced Peripheral Neuropathy","ProprioCIPN","Inclusion Criteria\n\nGeneral (applies to all participants):\n\n* At least 18 years of age at the time of signing the informed consent form\n* Voluntary written informed consent of the participant has been obtained prior to any screening procedures\n\nBreast cancer surgery-only patient group:\n\n* The patient is an adult oncological person between 18 and 75 years old who has been treated for cancer\n* The participant has undergone breast cancer surgery but has not received any radiotherapy or chemotherapy treatment (yet).\n* The first session takes place between two and six weeks after breast cancer surgery.\n* The second session takes before any follow-up treatment for breast cancer (radiotherapy or chemotherapy).\n\nChemotherapy group:\n\n* The patient is an adult oncological person between 18 and 75 years old who has been treated for cancer.\n* The participant has undergone breast cancer surgery but has not received any radiotherapy (yet).\n* Participant has a history of treatment with platinum- or taxane-based chemotherapeutic agents, and this treatment has been terminated no later than 6 weeks before the first session.\n\nHealthy control group:\n\n* No history of cancer or chemotherapy treatment\n* Sex and age-matched to patient sample\n\nExclusion Criteria:\n\nGeneral (applies to all participants):\n\n* Participant has a history of mental or physical disorders or neurological disease beyond those related to cancer treatments.\n* Participant uses any prescription or non-prescription drugs on a regular basis which, in the investigator's opinion, might confound the results of the study.\n* Participant is currently participating or has been involved in testing an investigational drug in another clinical study within the last 4 weeks which, in the investigator's opinion, might confound the results of the study.\n* Participant suffered from peripheral neuropathy prior to the chemotherapeutic treatment (Only for patients).\n* Participant has (a history of) a lesion in the central nervous system that is known to possibly cause neuropathic pain: e.g. spinal cord injury, infarction localized in the brainstem or thalamus, syringomyelia, multiple sclerosis, or any other disorder of the CNS that, in the investigator's opinion, may cause neuropathic pain.\n* If applicable: Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive",true,{"count":132,"type":20},145,"OBSERVATIONAL","Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most prevalent side-effects of chemotherapy, causing sensory and motor symptoms in patients. CIPN development is especially prevalent in chemotherapy treatment involving platinum- and taxane-based agents. The accompanying pain and deficits greatly impact the quality of life of these patients. Currently, patients are assessed for altered somatosensory using quantitative sensory testing (QST). The German Research Network on Neuropathic Pain (DFNS) has developed a standardized protocol which has been internationally recognized as approach for performing the QST. However, for proprioception the QST is limited to vibration assessments, making it limited as the only test to measure proprioception. Therefore, a comprehensive assessment of the proprioceptive functions is needed to better understand the influence CIPN has on the proprioception of patients, and thereby their quality of life.\n\nIn this project the effects of chemotherapy on somatosensory and proprioceptive functioning of breast cancer patients will be assessed in a cross-sectional study. This will be tested by comparing two groups of breast cancer patients and a healthy control group. Both patient groups will have undergone surgery for breast cancer, however, only one group will be tested after undergoing additional chemotherapy treatment. Thereby, the effects of chemotherapy between the surgery-only patient group and the chemotherapy patient group can tested. Furthermore, the investigators will compare both patient groups to sex- and age-matched healthy controls.",[27,136,137],"Chemotherapy-Induced Peripheral Neuropathy","Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer",[139,140,83,108,136,141,142,143,144,145,146],"Proprioception","Position Sense","Motor Control","Motion Capture","Marker-less","QST","Quantitative Sensory Testing","Robotic Assessment","2026-01-19",{"date":149,"type":34},"2026-01-26",{"date":151,"type":20},"2026-02",{"date":153,"type":20},"2027-11",{"name":155,"class":41},"KU Leuven",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":21,"phases":164,"briefSummary":165,"conditions":166,"keywords":168,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":42},"100586375","phase-2-scrambler-therapy-with-duloxetine-based-usual-care-vs-duloxetine-based-usual-care-for-chemotherapy-induced-peripheral-neuropathy-100586375","NCT06914557","Scrambler Therapy With Duloxetine-based Usual Care vs Duloxetine-based Usual Care for Chemotherapy-induced Peripheral Neuropathy.","Scrambler Therapy With Duloxetine-based Usual Care vs Duloxetine-based Usual Care for Chemotherapy-induced Peripheral Neuropathy: A Randomized Phase II Pilot Trial.","Inclusion Criteria:\n\n1. Persons aged 18 years or older with cancer\n2. Eastern Cooperative Oncology Group 0-2\n3. At least a 4\u002F10 average pain score prior to treatment\n4. At least CTCAE version 5.0 grade 2 neuropathies.\n5. Diagnosed CIPN based on chart review or oncologist diagnosis; will allow pre-existing diabetic neuropathy if symptoms are changing or worsening after chemotherapy.\n6. Score of at least 4 on the Douleur-Neuropathique-en-4 Questions (DN4) questionnaire\n7. Patients must have discontinued neurotoxic chemotherapy within the last 3 months with no additional therapy planned for the next 6 months after initiation of CIPN treatment.\n8. Patients must be on duloxetine at least 30 mg po daily for at least 4 weeks prior to study initiation\n9. Patients must be able to provide informed written consent.\n\nExclusion Criteria:\n\n1. Children or adolescents\n2. Pregnant or nursing patients\n3. Presence of an implantable life supporting medical device or implantable drug delivery system\n4. Patients with severe skin conditions preventing the proper application of electrodes\n5. Patients currently on monoamine oxidase inhibitors MAOIs.\n6. Patients currently receiving gabapentin who are unable to be weaned off for other medical reasons (ST requires tapering gabapentin).\n7. Patients with a symptomatic neuropathy from any type of nerve compression (e.g. carpal tunnel or tarsal tunnel, radiculopathy, spinal stenosis, or brachial plexopathy)\n8. Patients with leptomeningeal carcinomatosis- treated\u002Fstable brain metastases are allowed\n9. Patients with severe depression, suicidal ideation, bipolar disease, alcohol abuse, a major eating disorder\n10. Patients with uncontrolled epilepsy.\n11. Patients who have previously attempted or undergone Scrambler therapy.",{"count":76,"type":20},[104],"The investigators hypothesize that Scrambler therapy with duloxetine, compared to duloxetine-based usual care, will result in greater improvement in CIPN as measured by the BPI-Short Form. In addition, the investigators will further assess pain using the EORTC CIPN-20 and determine whether Scrambler therapy results in improved levels of function as measured with the PDQ, and a decreased need for opioid medications.\n\nOur primary objective is to investigate whether Scrambler therapy with duloxetine is superior to duloxetine-based usual care in achieving at least a 50% reduction in pain scores, when comparing the cross-sectionally measured \"average\" pain score at day 35 to the cross-sectionally measured \"average\" pain score at baseline.",[27,167],"Pain",[83,169,136,170,171],"neuropathy","Duloxetine","Scrambler Therapy","2025-04-07",{"date":174,"type":34},"2025-04-09",{"date":176,"type":34},"2025-03-03",{"date":178,"type":20},"2027-06-30",{"name":180,"class":41},"Fox Chase Cancer Center",{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":21,"phases":190,"briefSummary":191,"conditions":192,"keywords":194,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":42},"100571792","sensory-rehabilitation-in-chemo-induced-peripheral-neuropathy-100571792","NCT06724861","Sensory Rehabilitation in Chemo Induced Peripheral Neuropathy","Sensory Rehabilitation in CIPN","Inclusion Criteria:\n\n* CIPN by self-report (present or absent) \\> 3 months after last chemotherapy treatment\n* age \\> 18.\n\nExclusion Criteria:\n\n* Pre-chemotherapy neuropathy\u002F sensory impairment\n* recurrent falls prior to chemotherapy (more than 2 per year)\n* CNS involvement\n* not ambulatory before chemotherapy\n* Hebrew proficiency not meeting questionnaires' needs.",{"count":189,"type":20},27,[23],"This study is a cross-over RCT evaluating the effectiveness of 3 sessions a week apart of explicit sensory retraining to the lower extremities in individuals with CIPN versus usual care. The primary outcome measures are TNAS for subjective symptoms, VAS for pain and TUG for mobility. Additional outcome measures are FABS for balance, sensory assessments - monofilaments for touch threshold, LEPT for proprioception, a home exercise log and a satisfaction questionnaire.",[27,193,26],"Age Over 18",[195,196,197,198,199],"Neuropathic pain","Chemo Induced Peripheral Neuropathy (CIPN)","Sensory rehabilitation","Explicit Sensory Retraining","Lower extremity","2024-12-05",{"date":202,"type":34},"2024-12-09",{"date":204,"type":20},"2024-12-11",{"date":206,"type":20},"2026-12-11",{"name":208,"class":209},"Assaf-Harofeh Medical Center","OTHER_GOV",{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":16,"minAge":216,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":21,"phases":219,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":42},"100570802","comparison-of-the-efficacy-and-safety-of-mirogabalin-and-duloxetine-in-chemotherapy-induced-peripheral-neuropathy-in-a-randomized-controlled-trial-a-quality-of-life-study-in-cancer-survivors-100570802","NCT06711978","Comparison of the Efficacy and Safety of Mirogabalin and Duloxetine in Chemotherapy-induced Peripheral Neuropathy in a Randomized Controlled Trial: a Quality of Life Study in Cancer Survivors","Inclusion Criteria:\n\n* Cancer survivors aged 19 years or older.\n* Peripheral, symmetrical pain in both feet occurring within 12 weeks of initiating chemotherapy with taxane or platinum agents (or their combination).\n* Patients experiencing at least grade 2 peripheral neuropathy as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, with an average pain intensity of 4 or higher on the Numerical Rating Scale (NRS) during the past week, following the completion of chemotherapy.\n* Concurrent use of selected analgesics (acetaminophen, nonsteroidal anti-inflammatory drugs \\[NSAIDs\\]) is permitted if the following conditions are met:\n\n  1. No new analgesics are introduced.\n  2. Current analgesics are not discontinued.\n  3. The total weekly 24-hour dose of analgesics does not vary by more than 10% during the 2 weeks prior to enrollment.\n* Ongoing treatment for peripheral neuropathy or neuropathic pain must be discontinued at least 7 days before randomization\n\nExclusion Criteria:\n\n* Patients with a prior diagnosis of peripheral neuropathy due to diabetes, trauma, alcohol abuse, compression, or other causes, or those with a previously diagnosed central nervous system disorder. (Patients with pre-existing diabetes or thyroid disease who had no symptoms of peripheral neuropathy, such as numbness or tingling in the hands or feet, before chemotherapy may be included.)\n* Patients with significant psychiatric disorders, such as severe depression, bipolar disorder, or suicidal ideation.\n* Pregnant or breastfeeding patients.\n* Patients with a history of prior treatment with other neurotoxic chemotherapeutic agents.\n* Patients with renal impairment (creatinine clearance \\\u003C 30 mL\u002Fmin) or hepatic dysfunction.\n* Patients with planned surgical procedures within 4 weeks of enrollment.","19 Years",{"count":218,"type":20},66,[23],"To conduct a two-arm, parallel, prospective, randomized controlled, open-label trial to compare the efficacy of the novel drug mirogabalin with the conventional treatment duloxetine in reducing pain associated with chemotherapy-induced peripheral neuropathy (CIPN).\n\nThere will be a difference in pain reduction after 4 weeks of treatment between the mirogabalin group and the duloxetine group in patients with chemotherapy-induced peripheral neuropathy (CIPN).\n\nParticipants will:\n\n* Take drug duloxetine or a mirogabalin every day for 4 weeks.\n* Visit the clinic once every 2 weeks for checkups and tests",[83,27,222,170,223],"CIPN in Adjuvant Breast Cancer Patients","Mirogabalin","2024-11-26",{"date":226,"type":34},"2024-12-02",{"date":228,"type":20},"2024-12-01",{"date":230,"type":20},"2025-06-30",{"name":232,"class":41},"Pusan National University Yangsan Hospital",{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":21,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":42},"100510591","effects-of-cryotherapy-on-taxane-induced-neuropathy-in-patients-with-breast-cancer-100510591","NCT05928429","Effects of Cryotherapy on Taxane-Induced Neuropathy in Patients With Breast Cancer","Effects of Cryotherapy on Objective and Subjective Symptoms of Taxane-Induced Neuropathy in Patients With Early Breast Cancer: A National, Multicenter, Prospective, Randomized, Controlled Trial","Inclusion Criteria:\n\nKey inclusion criteria; Patients with early breast cancer scheduled to receive weekly paclitaxel (80mg\u002Fm2 for one hour) 9 or 12 doses, PS 0-1\n\nExclusion Criteria:\n\nPeripheral sensory\u002Fmotor neuropathy, neuralgia or edema of the limb graded \\>=2 (CTCAE ver 5.0), Patient with Raynaud's symptoms; peripheral arterial ischemia; or any other reasons based on the primary physician's judgment.",{"count":241,"type":20},300,[23],"Due to well-proven survival benefit, paclitaxel and other taxane-based chemotherapies are first-line agents for both the adjuvant and neoadjuvant treatment of early stage breast cancer. Chemotherapy-induced peripheral neuropathy (CIPN) is a frequent and disabling side effect of taxane anticancer agents. No established strategy exists for CIPN prevention. This study is designed to assess the efficacy and safety of cryotherapy for the prevention of paclitaxel-induced peripheral neuropathy in patients with breast cancer in a prospective randomized controlled trial.",[27,108],"2023-06-23",{"date":247,"type":34},"2023-07-03",{"date":249,"type":34},"2021-01-15",{"date":251,"type":20},"2026-11-30",{"name":253,"class":41},"Maria Lendorf"]