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High-concentration Capsaicin Patch for the Prevention of Paclitaxel-induced Peripheral Neuropathy

StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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/or 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.
Trial Details
NCT Number NCT07834281
Lead Sponsor Case Comprehensive Cancer Center
Conditions
(from sponsor)
Chemotherapy-induced Peripheral Neuropathy, CIPN - Chemotherapy-Induced Peripheral Neuropathy
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov