TRPM8 Activators for Peripheral Neuropathy

The goal of this pilot prospective cohort study is to evaluate the efficacy of a novel hand and foot mask in alleviating symptoms of peripheral neuropathy caused by chemotherapy or diabetes. The study aims to determine whether regular use of these masks can improve patient comfort and quality of life. The primary questions this study aims to answer are: Does the use of the hand and foot mask reduce the severity of symptoms associated with chemotherapy-induced peripheral neuropathy (CIPN) or diabetic peripheral neuropathy (DPN)? Does the application of the masks improve patient quality of life and treatment compliance for those undergoing chemotherapy? Participants will: Complete an initial assessment questionnaire on Day 1. Apply hand and foot masks daily for 5 minutes, for 7 consecutive days. Complete a follow-up questionnaire on Day 7 to assess the effects of one week of use. Inclusion Criteria Individuals are eligible for the study if they meet the following criteria: Chemotherapy-Induced Peripheral Neuropathy (CIPN) group: Age 20 or older. Currently receiving or having previously received chemotherapy. Demonstrating clinical signs and symptoms of chemotherapy-induced peripheral neuropathy. Diabetic Peripheral Neuropathy (DPN) group: Age 20 or older. Diagnosed with diabetes mellitus. Demonstrating clinical signs and symptoms of diabetic peripheral neuropathy. General requirement: Participants must be willing to participate and capable of signing the Informed Consent Form (ICF).

NCT Number	NCT07583797
Lead Sponsor	SHIANG-SUO HUANG
Conditions	CIPN - Chemotherapy-Induced Peripheral Neuropathy, Diabetic Peripheral Neuropathy (DPN)
Enrollment	60 participants
Start Date	2025-11-03
Primary Completion	2026-04-07 (estimated)
Study Completion	2026-06-01 (estimated)
Updated on ClinicalTrials.gov	2026-05-15