[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657128":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":58,"studyPopulation":47,"armGroups":59,"interventions":80,"overallOfficials":89,"centralContacts":94,"locations":103,"responsibleParty":121,"collaborators":47,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":47,"eligibilityCriteria":129,"healthyVolunteers":125,"sex":130,"minAge":131,"maxAge":132,"enrollmentInfo":133,"targetDuration":47,"studyType":136,"phases":137,"briefSummary":139,"conditions":140,"keywords":143,"overallStatus":146,"whyStopped":47,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"Case Comprehensive Cancer Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":47},[9],{"measure":10,"description":11,"timeFrame":12},"Change in taxane-induced peripheral neuropathy due to HCCP patch","Change in taxane-induced peripheral neuropathy is measured by the incidence of grade ≥2 neuropathy (Common Terminology Criteria for Adverse Events, CTCAE v5.0).","Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52",[14,17,20,23,26,29,32,35,38,41,44],{"measure":15,"description":16,"timeFrame":12},"Change in FACT-GOG-Ntx scores","The Functional Assessment of Cancer Therapy\u002FGynecologic Oncology Group - Neurotoxicity (FACT\u002FGOG-NTX) is a 13-item questionnaire that asks participants to rank symptoms of daily function on a 5-point Likert scale from Not at all (0) to Very much (4). Higher scores indicate greater quality of life.",{"measure":18,"description":19,"timeFrame":12},"Change in PROMIS Pain Interference scores","The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference questionnaire is a 8-item questionnaire that assesses the daily impacts of pain. Each item is answered on a 5-point Likert scale from Not at all (1) to Very much (5). Higher scores indicate greater pain interference.",{"measure":21,"description":22,"timeFrame":12},"Change in PROMIS Physical Function scores","The Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function questionnaire is a 8-item questionnaire that assesses daily physical functioning. Four questions are answered on a 5-point Likert scale from Without any difficulty (5) to Unable to do (1), and the other 4 questions answered on a 5-point Likert scale from Not at all (5) to Cannot do (1). Higher scores indicate greater physical functioning.",{"measure":24,"description":25,"timeFrame":12},"Change in PROMIS Sleep Disturbance scores","The Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance questionnaire is a 8-item questionnaire that assesses sleep disturbance. One question asks participants to ran their sleep quality on a 5-point scale from \"Very poor\" to \"Very good.\" Seven questions are answered on a 5-point Likert scale from Not at all (5) to Very much (1). Higher scores indicate worse sleep disturbance.",{"measure":27,"description":28,"timeFrame":12},"Change in EQ-5D-5L scores","The EuroQol 5-Dimension, 5-Level (EQ-5D-5L) questionnaire has 5 dimensions: mobility, self-care, usual activities, pain\u002Fdiscomfort and anxiety\u002Fdepression. Each dimension has 5 levels that the participant can choose from: no problems, slight problems, moderate problems, severe problems and extreme problems. These numbers are combined for a 5-digit number that describes the participant's health status.",{"measure":30,"description":31,"timeFrame":12},"Change in Patient Global Impression of Change (PGIC) scores","Patient Global Impression of Change (PGIC) questionnaire contains one question that asks the participant to rank their overall health status on a 7-point Likert scale from (1) Very much improved to (7) Very much worse. Higher scores indicate worse health status.",{"measure":33,"description":34,"timeFrame":12},"Change in EORTC QLQ-CIPN20 scores","The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20-Item Scale (EORTC QLQ-CIPN20) questionnaire is a 20-item questionnaire that assess symptoms of chemotherapy-induced peripheral neuropathy (CIPN). Participants answer questions on a 4-point Likert scale from Not at all (1) to Very much (4). Higher scores indicate greater symptoms of CIPN.",{"measure":36,"description":37,"timeFrame":12},"Change in Numeric Rating Scale for pain (NRS) scores","The Numeric Rating Scale (NRS) for pain is a one-item question that asks participants to rank their pain on a scale of 0 to 10 from None (0) to Severe (10). Higher rankings indicate more severe pain.",{"measure":39,"description":40,"timeFrame":12},"Time-to-onset of paclitaxel-induced peripheral neuropathy (PIPN)","Time-to-onset of PIPN will be measured as the days from start of treatment (Week 1) to the first reported day of PIPN. This question will be asked at Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52.",{"measure":42,"description":43,"timeFrame":12},"Cumulative paclitaxel dose","Cumulative paclitaxel dose will be measured as the amount of paclitaxel a participant receives in total (from Week 0 and up to Week 52). This question will be asked at Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52.",{"measure":45,"description":46,"timeFrame":12},"Dose reductions or delays due to neuropathy","The number of instances of dose reductions or delays due to neuropathy will be measured as the incidence in total (from Week 0 and up to Week 52). This question will be asked at Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52.",null,{"allocation":49,"interventionModel":50,"interventionModelDescription":47,"primaryPurpose":51,"observationalModel":47,"timePerspective":47,"maskingInfo":52},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":53,"maskingDescription":47,"whoMasked":54},"TRIPLE",[55,56,57],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","Chemotherapy-induced peripheral neuropathy (CIPN) is a common, serious side effect of drugs used to treat cancer, such as taxanes. CIPN affects up to 80% of people receiving chemotherapy cancer treatment, and the incidence of CIPN is expected to increase as cancer survival increases. CIPN can cause sensory loss, neuropathic (nerve-related) pain, gait instability (problems with balance), and fine motor impairment. These symptoms can often continue for years after treatment is completed. These symptoms may also cause doctors to lower or stop chemotherapy, which may affect the outcomes of cancer treatment. CIPN is a leading cause of poor quality of life for millions of cancer survivors.\n\nDespite how common and serious CIPN is, there are no FDA-approved preventive therapies for CIPN. The high-concentration capsaicin patch (HCCP, 8%) is an FDA-approved topical therapy for peripheral neuropathic pain that acts by prolonged activation and reversible \"defunctionalization\" of nerve cells called Transient Receptor Potential Vanilloid 1 (TRPV1)-expressing sensory neurons. TRPV1 plays an important role in how pain is felt by acting as a receptor on sensory neurons. This means that it detects and relays painful stimuli to the central nervous system. Damaging TRPV1 by using the topical HCCP patch leads to temporary relief without permanent nerve injury or systemic side effects. HCCP has demonstrated clinical efficacy in treating established CIPN; however, its use as a preventive intervention has not been reported. Preclinical and translational data indicate that early modulation of TRPV1-calcium signaling may prevent maladaptive neuronal hyperexcitability and epigenetic changes that underlie chronic neuropathy. Thus, repurposing HCCP to preemptively modulate this pathway represents a novel, mechanism-based opportunity to prevent CIPN before irreversible neurodegeneration occurs.\n\nThis project directly addresses a high-impact unmet need by testing whether pretreatment with HCCP reduces the incidence and severity of CIPN. By integrating a randomized, placebo-controlled clinical trial with multimodal neurophysiological, participant-reported, and molecular assessments, this work will generate rigorous clinical and mechanistic evidence supporting a scalable, non-invasive, and rapidly translatable prevention strategy. If successful, these findings will shift the CIPN management paradigm from reactive symptom control to proactive prevention, improving treatment adherence, functional outcomes, and survivorship quality.",[60,66,70,76],{"label":61,"type":62,"description":63,"interventionNames":64},"HCCP 30-minute application","EXPERIMENTAL","The 8% High Concentration Capsaicin Patch (HCCP) patch will be administered in an outpatient setting one week prior to the initiation of standard of care chemotherapy. The patch will be administered either on the hand or foot. It will be applied for 30 minutes. If the participant is expected to receive standard of care chemotherapy at Week 12, then they will receive a second HCCP patch on Week 11.",[65],"Other: High Concentration Capsaicin Patch (HCCP)",{"label":67,"type":62,"description":68,"interventionNames":69},"HCCP 60-minute application","The 8% High Concentration Capsaicin Patch (HCCP) patch will be administered in an outpatient setting one week prior to the initiation of standard of care chemotherapy. The patch will be administered either on the hand or foot. It will be applied for 60 minutes. If the participant is expected to receive standard of care chemotherapy at Week 12, then they will receive a second HCCP patch on Week 11.",[65],{"label":71,"type":72,"description":73,"interventionNames":74},"Placebo 30-minute application","PLACEBO_COMPARATOR","This arm will receive a matched placebo patch containing 0.025% capsaicin. The patch will be administered in an outpatient setting one week prior to the initiation of standard of care chemotherapy. The patch will be administered either on the hand or foot. It will be applied for 30 minutes. If the participant is expected to receive standard of care chemotherapy at Week 12, then they will receive a second HCCP patch on Week 11.",[75],"Other: Placebo patch",{"label":77,"type":72,"description":78,"interventionNames":79},"Placebo 60-minute application","This arm will receive a matched placebo patch containing 0.025% capsaicin. The patch will be administered in an outpatient setting one week prior to the initiation of standard of care chemotherapy. The patch will be administered either on the hand or foot. It will be applied for 60 minutes. If the participant is expected to receive standard of care chemotherapy at Week 12, then they will receive a second HCCP patch on Week 11.",[75],[81,85],{"type":6,"name":82,"description":83,"armGroupLabels":84,"otherNames":47},"High Concentration Capsaicin Patch (HCCP)","Participants will receive 8% HCCP patch. It will be administered on the hand or foot for either 30 or 60 minutes, depending on which arm the participant is in. It will be administered at baseline (Week 0), just prior to starting standard of care chemotherapy. It will be administered again on Week 11, as long as the participant is expected to receive standard of care chemotherapy on Week 12.",[61,67],{"type":6,"name":86,"description":87,"armGroupLabels":88,"otherNames":47},"Placebo patch","Participants will receive the placebo patch containing 0.025% capsaicin. It will be administered on the hand or foot for either 30 or 60 minutes, depending on which arm the participant is in. It will be administered at baseline (Week 0), just prior to starting standard of care chemotherapy. It will be administered again on Week 11, as long as the participant is expected to receive standard of care chemotherapy on Week 12.",[71,77],[90],{"name":91,"affiliation":92,"role":93},"Jijun Xu, MD, PhD","Case Comprehensive Cancer Center, Cleveland Clinic","PRINCIPAL_INVESTIGATOR",[95,99],{"name":91,"role":96,"phone":97,"phoneExt":47,"email":98},"CONTACT","(216) 444-4080","Xuj3@ccf.org",{"name":100,"role":96,"phone":101,"phoneExt":47,"email":102},"Heather Rogers","(216) 444-1292","ROGERSH3@ccf.org",[104],{"facility":105,"status":47,"city":106,"state":107,"zip":108,"country":109,"countryCode":110,"cosmosGeoPoint":111,"geoPoint":116,"contacts":117},"Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center","Cleveland","Ohio","44195","United States","US",{"type":112,"coordinates":113},"Point",[114,115],-81.69541,41.4995,{"lat":115,"lon":114},[118,120],{"name":91,"role":96,"phone":119,"phoneExt":47,"email":98},"216-444-4080",{"name":91,"role":93,"phone":47,"phoneExt":47,"email":47},{"type":122,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR","100657128","phase-4-high-concentration-capsaicin-patch-for-the-prevention-of-paclitaxel-induced-peripheral-neuropathy-100657128",false,"NCT07834281","High-concentration Capsaicin Patch for the Prevention of Paclitaxel-induced Peripheral Neuropathy","High-concentration Capsaicin Patch for the Prevention of Paclitaxel-induced Peripheral Neuropathy- a Prospective, Double-blind, Randomized, Placebo-controlled Trial","Inclusion Criteria:\n\n* Adult participants (ages 18-65 years old)\n* Eligible participants must have intact skin in the areas to be treated (hands and feet)\n* Participants must have the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants with pre-existing peripheral neuropathy, concurrent use of other neurotoxic medications, palliative-intent chemotherapy, pregnancy, inability to provide informed consent or participate in follow-up visits, or any contraindications listed in the HCCP Summary of Product Characteristics (SmPC)8 will be excluded.\n* Pregnant or breastfeeding women are excluded from this study because Paclitaxel is a chemotherapy agent with the potential for teratogenic or abortifacient effects.\n* HIV-positive participants will not be excluded unless the participant has an established peripheral neuropathy related to HIV or its treatment. HIV testing is not required for this study.","ALL","18 Years","65 Years",{"count":134,"type":135},240,"ESTIMATED","INTERVENTIONAL",[138],"PHASE4","This research study is for participants who are receiving paclitaxel infusion as part of their cancer treatment. The purpose of this study is to test the effectiveness of the Food and Drug Administration (FDA) approved high-concentration (8%) capsaicin patch (HCCP) in prevention of taxane-induced peripheral neuropathy (nerve pain in hands and\u002For feet). Participants will be randomized, like flipping a coin, into one of four groups. Group one will receive the HCCP on one hand and one foot 60 minutes prior to each infusion. Group two will receive the HCCP on one hand and one foot 30 minutes prior to each infusion. Group three will receive a placebo patch on one hand and one foot containing a very low concentration of capsaicin (0.025%) for 60 minutes prior to infusion. Group four will receive a placebo patch on one hand and one foot for 30 minutes prior to infusion. Participants will have an equal chance of being placed in each of the four groups.",[141,142],"Chemotherapy-induced Peripheral Neuropathy","CIPN - Chemotherapy-Induced Peripheral Neuropathy",[144,145],"high-concentration capsaicin patch","HCCP","NOT_YET_RECRUITING","2026-09-17",{"date":149,"type":150},"2026-09-22","ACTUAL",{"date":152,"type":135},"2026-10-01",{"date":154,"type":135},"2028-06",{"name":5,"class":6},1]