TRPM8 Activators for Peripheral Neuropathy

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).

Timeline

Start

2025-11-03

Primary completion

2026-04-07

Completion

2026-06-01

Publications

• Background 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

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