This clinical trial tests how well topical capsaicin patches work in treating pain and improving gait (the pattern of walking) in patients with chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a challenging complication of many chemotherapeutic regimens. It is most commonly associated with three types of cancer treatment: vinca alkaloid, such as vincristine; taxanes, such as taxol; and bortezomib. CIPN is characterized by numbness, tingling sensations, persistent shooting, stabbing, or burning pain, loss of skin sensation, muscle weakness in the arms or legs, and impaired balance. Capsaicin is a chili pepper extract with analgesic properties and works as a neuropeptide releasing agent selective for primary sensory peripheral neurons. Used topically, capsaicin aids in controlling peripheral nerve pain. Giving capsaicin patches topically may be effective in treating patients with chemotherapy-induced peripheral neuropathy.
Additional locations may be listed on ClinicalTrials.gov for NCT06744816.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Approved
Contact: Saba Javed
Phone: 713-745-2933
PRIMARY OBJECTIVE:
I. To assess changes in gait (specifically looking at velocity) before and after use of topical capsaicin.
SECONDARY OBJECTIVES:
I. To assess pain intensity numerical rating scale (NRS) scores in chemotherapy induced peripheral neuropathy (CIPN) patients before and after use of capsaicin 8% topical patch.
II. To assess changes in quantitative sensory testing (QST) before and after use of topical capsaicin.
III. 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).
IV. To assess pain tumor related neuropathy assessment scale (TNAS) before and after topical capsaicin.
V. To assess pain interference using the Brief Pain Inventory (BPI), before and after topical capsaicin.
VI. To assess Patient Global Impression of Change (PGIC).
VII. To assess the rate of adverse events and tolerability of topical capsaicin as reported by patients.
OUTLINE:
Patients receive capsaicin patches topically to their feet over 30 minutes on study. Patients also undergo skin biopsies at baseline and follow-up.
After completion of study treatment, patients are followed up on days 30, 60, and 90.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorSaba Javed
