[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06744816":3,"trial-entities:NCT06744816":86,"trial-summary:NCT06744816":90},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":39,"sex":40,"minimum_age":41,"maximum_age":42,"healthy_volunteers":43,"eligibility_criteria":44,"std_ages":57,"locations":60,"central_contacts":78,"overall_officials":80,"references":82,"see_also_links":83},"NCT06744816","2024-1601","Exploring the Benefit of Topical Capsaicin in Treating Pain From Chemo-induced Peripheral Neuropathy: a Longitudinal Single Center Pilot Study","RECRUITING","2027-11-30","2026-06","2026-06-26","2025-12-11","M.D. Anderson Cancer Center","OTHER",true,"To learn if topical capsaicin can help relieve pain from CIPN and improve gait (the pattern of walking) in patients.","Primary Objectives\n\n• To assess changes in Gait (specifically looking at velocity) before and after use of topical capsaicin.\n\nSecondary Objectives\n\n* To assess Pain intensity numerical rating scale (NRS) scores in chemotherapy induced peripheral neuropathy (CIPN) participants before and after use of capsaicin 8% topical patch.\n* To assess changes in quantitative sensory testing (QST) before and after use of topical capsaicin.\n* To assess skin punch biopsy to compare the integrity of epidermal nerve fibers and Meissner's corpuscles (MC) in CIPN patients before and after use of topical capsaicin (optional).\n* To assess pain tumor related neuropathy assessment scale (TNAS) before and after topical capsaicin\n* To assess pain interference using the Brief Pain Inventory (BPI), before and after topical capsaicin\n* To assess Patient Global Impression of Change (PGIC)\n* To assess the rate of adverse events and tolerability of topical capsaicin as reported by participants",[18],"Peripheral Neuropathy Due to Chemotherapy",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[23],"EARLY_PHASE1",{"count":25,"type":26},20,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DRUG","Qutenza Patch","Given topical",[33],"Treatment with Qutenza Patch (Topical Capsaicin)",[35],{"measure":36,"description":37,"timeFrame":38},"Safety and adverse events (AE)s","Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0","Through study completion; an average of 1 year",[],"ALL","18 Years",null,false,{"inclusion":45,"exclusion":50,"raw_text":56},[46,47,48,49],"Participants diagnosed with pain of the lower extremity from chronic (\\>90 days duration) CIPN (due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds), seen at MD Anderson Cancer Center","Participants reporting baseline pain ≥ 4 (0-10 scale, NRS)","Participants age 18+","Participants who have completed chemotherapy within the last year at the time of enrollment.",[51,52,53,54,55],"Participants with cognitive dysfunction","Participants with recent history (\\\u003C6 months) of drug or alcohol abuse","Participants with open skin lesion or undergoing antibiotic therapy for local for systemic infection","Participants with allergies to capsaicin or adhesives","Pregnant participants","Inclusion Criteria:\n\n* Participants diagnosed with pain of the lower extremity from chronic (\\>90 days duration) CIPN (due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds), seen at MD Anderson Cancer Center\n* Participants reporting baseline pain ≥ 4 (0-10 scale, NRS)\n* Participants age 18+\n* Participants who have completed chemotherapy within the last year at the time of enrollment.\n\nExclusion Criteria:\n\n* Participants with cognitive dysfunction\n* Participants with recent history (\\\u003C6 months) of drug or alcohol abuse\n* Participants with open skin lesion or undergoing antibiotic therapy for local for systemic infection\n* Participants with allergies to capsaicin or adhesives\n* Pregnant participants",[58,59],"ADULT","OLDER_ADULT",[61],{"facility":62,"status":7,"city":63,"state":64,"zip":65,"country":66,"contacts":67,"geoPoint":75},"MD Anderson Cancer Center","Houston","Texas","77030","United States",[68,73],{"name":69,"role":70,"phone":71,"email":72},"Saba Javed, MD","CONTACT","713-792-9530","sjaved@mdanderson.org",{"name":69,"role":74},"PRINCIPAL_INVESTIGATOR",{"lat":76,"lon":77},29.76328,-95.36327,[79],{"name":69,"role":70,"phone":71,"email":72},[81],{"name":69,"affiliation":12,"role":74},[],[84],{"label":62,"url":85},"http:\u002F\u002Fwww.mdanderson.org",{"nct_id":4,"conditions":87,"biomarkers":89},[88],"Peripheral Neuropathy",[],{"nct_id":4,"found":14,"summary":91,"prompt_version":101},{"design":92,"status":93,"heading":94,"summary":95,"follow_up":96,"word_count":97,"commitments":98,"compensation":99,"drugs_mentioned":100},"This is a single-center pilot study, meaning it's a small, initial study at one location. It is an interventional study, but the phase is not specified.","completed","Topical Capsaicin for Chemotherapy-Induced Peripheral Neuropathy Pain","This study is exploring if a topical patch called Qutenza (capsaicin) can help reduce pain from chemotherapy-induced peripheral neuropathy (CIPN) and improve walking. CIPN is nerve damage caused by chemotherapy, leading to pain. Researchers want to see how safe Qutenza is and if it helps with pain intensity and how people walk. You might be able to join if you are at least 18 years old, have chronic CIPN pain in your legs (lasting over 90 days) from certain chemotherapy drugs, and your pain is rated 4 or higher on a 0-10 scale. You must have finished chemotherapy within the last year and be seen at MD Anderson Cancer Center. The study aims to enroll 20 participants.","Your safety and side effects will be monitored throughout the study, for an average of one year.",117,"The study will assess changes in your walking, pain intensity, and sensation before and after using topical capsaicin. Some optional tests include skin biopsies.","Not stated in the trial record.",[],"v2"]