TRPM8 Activators for Peripheral Neuropathy

NCT07583797 | Active Not Recruiting Phase 2

• 1 other identifier: CS2-25059
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Peripheral Neuropathy; Chemotherapy; Diabetes; hand and foot mask; CIPN; DPN; TRPM8

Outcome Measures

Primary Outcomes (2)

• Change in Norfolk Quality of Life Questionnaire-Diabetic Neuropathy (Norfolk QOL-DN) Score

  The Norfolk QOL-DN is a validated instrument to assess the quality of life in patients with diabetic neuropathy. Scores range from 0 to 4 for each item, where 0 indicates "not at all" and 4 indicates "very much." A change in the total score will be calculated to measure the impact of the intervention.

  From baseline (Day 1) to the end of the treatment (Day 7).

• Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CIPN20) Score

  The EORTC QLQ-CIPN20 is a specialized module for assessing chemotherapy-induced peripheral neuropathy symptoms. Scores range from 0 to 3 for each item, where 0 indicates "not at all" and 3 indicates "very much." A change in the total score will be calculated to measure the impact of the intervention.

  From baseline (Day 1) to the end of the treatment (Day 7).

Study Arms (1)

treatment

EXPERIMENTAL

Combination Product: Hand and Foot Mask

Interventions

Hand and Foot Mask COMBINATION_PRODUCT

Daily topical application for 5 minutes over 7 days

treatment

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 20 years or older who are currently receiving or have previously received chemotherapy and have clinical features of chemotherapy-induced peripheral neuropathy (CIPN).
• Diabetic patients aged 20 years or older who have clinical features of diabetic peripheral neuropathy (DPN).
• Patients who meet criteria 1 or 2, are willing to participate, and are able to sign an informed consent form.

You may not qualify if:

• Poorly controlled diabetes (HbA1c \> 8%).
• Peripheral vascular disease.
• Chronic kidney disease (eGFR \< 30 ml/min/m²).
• Depression, history of surgery on the hands, feet, or back.
• Skin conditions such as leprosy and connective tissue disorders, familial neuropathy.
• Pregnant or breastfeeding women.
• Individuals with allergic symptoms.
• Individuals with a history of convulsions.
• Individuals with G6PD deficiency (favism).

Sponsors & Collaborators

• SHIANG-SUO HUANG: lead

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, Taichung, 402306, Taiwan

Location

Related Publications (10)

• Wesam S. A., S. A. A., Afnan M. I. K., Amal H. A., Amirah S. A., Areej M. A., Hessa H. A. (2023). Exploring Chemotherapy-Induced Peripheral Neuropathy (CIPN) in Cancer Patients at a Tertiary-Care Hospital: Incidence, Symptoms and Risk Factors. INT J MED RES HEALTH, 17(7), 1-15.

  BACKGROUND

• Wang J, Xu W, Wang Q, Yang P, Kan Y, Huang C, Lin F. Efficacy and Safety of Ultrasound-Guided Pulsed Radiofrequency Therapy of Stellate Ganglion on Refractory Painful Diabetic Peripheral Neuropathy. J Pain Res. 2024 Dec 25;17:4521-4531. doi: 10.2147/JPR.S497061. eCollection 2024.

  PMID: 39737247 BACKGROUND

• Vinik EJ, Hayes RP, Oglesby A, Bastyr E, Barlow P, Ford-Molvik SL, Vinik AI. The development and validation of the Norfolk QOL-DN, a new measure of patients' perception of the effects of diabetes and diabetic neuropathy. Diabetes Technol Ther. 2005 Jun;7(3):497-508. doi: 10.1089/dia.2005.7.497.

  PMID: 15929681 BACKGROUND

• Rastogi A, Uppula P, Saikia U, Bhansali A. Effect of Monochromatic Infrared Energy on Quality of Life and Intraepidermal Nerve Fiber Density in Painful Diabetic Neuropathy: A Randomized, Sham Control Study. Neurol India. 2021 Sep-Oct;69(5):1331-1337. doi: 10.4103/0028-3886.329614.

  PMID: 34747807 BACKGROUND

• Ramachandran R, Hyun E, Zhao L, Lapointe TK, Chapman K, Hirota CL, Ghosh S, McKemy DD, Vergnolle N, Beck PL, Altier C, Hollenberg MD. TRPM8 activation attenuates inflammatory responses in mouse models of colitis. Proc Natl Acad Sci U S A. 2013 Apr 30;110(18):7476-81. doi: 10.1073/pnas.1217431110. Epub 2013 Apr 17.

  PMID: 23596210 BACKGROUND

• Proudfoot CJ, Garry EM, Cottrell DF, Rosie R, Anderson H, Robertson DC, Fleetwood-Walker SM, Mitchell R. Analgesia mediated by the TRPM8 cold receptor in chronic neuropathic pain. Curr Biol. 2006 Aug 22;16(16):1591-605. doi: 10.1016/j.cub.2006.07.061.

  PMID: 16920620 BACKGROUND

• Postma TJ, Aaronson NK, Heimans JJ, Muller MJ, Hildebrand JG, Delattre JY, Hoang-Xuan K, Lanteri-Minet M, Grant R, Huddart R, Moynihan C, Maher J, Lucey R; EORTC Quality of Life Group. The development of an EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy: the QLQ-CIPN20. Eur J Cancer. 2005 May;41(8):1135-9. doi: 10.1016/j.ejca.2005.02.012. Epub 2005 Apr 14.

  PMID: 15911236 BACKGROUND

• Jensen MP, Gammaitoni AR, Olaleye DO, Oleka N, Nalamachu SR, Galer BS. The pain quality assessment scale: assessment of pain quality in carpal tunnel syndrome. J Pain. 2006 Nov;7(11):823-32. doi: 10.1016/j.jpain.2006.04.003.

  PMID: 17074624 BACKGROUND

• Hsieh YL, Chou LW, Hong SF, Chang FC, Tseng SW, Huang CC, Yang CH, Yang CC, Chiu WF. Laser acupuncture attenuates oxaliplatin-induced peripheral neuropathy in patients with gastrointestinal cancer: a pilot prospective cohort study. Acupunct Med. 2016 Oct;34(5):398-405. doi: 10.1136/acupmed-2016-011112. Epub 2016 Sep 9.

  PMID: 27613370 BACKGROUND

• Huang SS, Su HH, Chien SY, Chung HY, Luo ST, Chu YT, Wang YH, MacDonald IJ, Lee HH, Chen YH. Activation of peripheral TRPM8 mitigates ischemic stroke by topically applied menthol. J Neuroinflammation. 2022 Jul 27;19(1):192. doi: 10.1186/s12974-022-02553-4.

  PMID: 35897101 BACKGROUND

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Shiang-Suo Huang, PhD

  Chung Shan Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Pharmacology and Institute of Medicine, Chung Shan Medical University

Model Details: This is a single-group study where all participants receive the intervention. The study design employs a pre- and post-intervention assessment to evaluate changes within the same subjects over the 7-day study period.

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 13, 2026
• Study Start: November 3, 2025
• Primary Completion: April 7, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

TW (1)