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TRPM8 Activators for Peripheral Neuropathy

NCT07583797 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-15

No results posted yet for this study

Summary

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).

Conditions

  • CIPN - Chemotherapy-Induced Peripheral Neuropathy
  • Diabetic Peripheral Neuropathy (DPN)

Interventions

COMBINATION_PRODUCT

Hand and Foot Mask

Daily topical application for 5 minutes over 7 days

Sponsors & Collaborators

  • SHIANG-SUO HUANG

    lead OTHER

Principal Investigators

  • Shiang-Suo Huang, PhD · Chung Shan Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-03
Primary Completion
2026-04-07
Completion
2026-06-01

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07583797 on ClinicalTrials.gov