Topical Herbal Medicine for Chemotherapy-Induced Peripheral Neuropathy

Summary

The goal of this clinical trial is to learn if menthol works to relieve chronic neuropathic pain and chemotherapy-induced peripheral neuropathy (CIPN). The primary objectives are to evaluate the safety and clinical efficacy of menthol-containing gloves and foot-covers, specifically whether they can improve patient-reported hypoesthesia (numbness). Secondary objectives include assessing the sustained effects on pain, dysesthesia (abnormal sensations), allodynia (touch-induced pain), and overall quality of life. Additionally, this study will include an exploratory lab analysis using blood samples to investigate potential biological markers (small extracellular vesicles and microRNA) associated with treatment responses. Participants will be asked to: Wear menthol-containing gloves and foot-covers (or shams) daily for 5 minutes per session over a 14-day period. Attend clinic visits on Days 1, 14, 21, and 28 for evaluations and tests.

Timeline

Start

2025-05-12

Primary completion

2027-01-31

Completion

2027-01-31

Publications

• Background Colvin LA. Chemotherapy-induced peripheral neuropathy: where are we now? Pain. 2019 May;160 Suppl 1(Suppl 1):S1-S10. doi: 10.1097/j.pain.0000000000001540.
• Background Smith EM, Pang H, Cirrincione C, Fleishman S, Paskett ED, Ahles T, Bressler LR, Fadul CE, Knox C, Le-Lindqwister N, Gilman PB, Shapiro CL; Alliance for Clinical Trials in Oncology. Effect of duloxetine on pain, function, and quality of life among patients with chemotherapy-induced painful peripheral neuropathy: a randomized clinical trial. JAMA. 2013 Apr 3;309(13):1359-67. doi: 10.1001/jama.2013.2813.
• Background Park SB, Goldstein D, Krishnan AV, Lin CS, Friedlander ML, Cassidy J, Koltzenburg M, Kiernan MC. Chemotherapy-induced peripheral neurotoxicity: a critical analysis. CA Cancer J Clin. 2013 Nov-Dec;63(6):419-37. doi: 10.3322/caac.21204.

Drugs

Indications