- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07583797
TRPM8 Activators for Peripheral Neuropathy
The Effect of Innovative TRPM8 Activators Membrane-Based Delivery System on 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).
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
Peripheral neuropathy (PN) is a condition characterized by damage or dysfunction of the peripheral nerves, leading to sensory, motor, or autonomic impairments. Symptoms often include numbness, tingling, burning sensations, muscle weakness, and paresthesia. Chemotherapy-induced peripheral neuropathy (CIPN) and diabetic peripheral neuropathy (DPN) are two of the most prevalent causes of PN. Current pharmacological treatments, such as analgesics, anticonvulsants, antidepressants, and opioids, often provide limited efficacy and are frequently associated with significant adverse effects.
Study Rationale and Mechanism of Action:
The "Speedell" hand and foot mask is a novel product formulated to act primarily as a TRPM8 activator. TRPM8 is a non-selective cation channel with six transmembrane domains, widely expressed in human nerve cells. Upon activation by temperatures between 8-28°C or by specific agonists, TRPM8 generates cold signals that are transmitted to the somatosensory cortex.
Scientific literature suggests that the activation of TRPM8-whether by agonists or moderate cooling-induces the release of glutamate at central synapses. This glutamate subsequently activates inhibitory group II/III metabotropic glutamate receptors (mGluRs) located on injured nociceptive afferent neurons or postsynaptic receptors in the dorsal horn, thereby attenuating neuropathic hypersensitivity.
Furthermore, Speedell is designed to deliver natural cooling agents efficiently to the extremities, where they interact with TRPM8 receptors to provide immediate sensory relief. Evidence suggests that these components may contribute to the reduction of tissue damage caused by cellular inflammation. This pilot study aims to clinically validate the efficacy of the Speedell hand and foot mask in alleviating neuropathic discomfort and improving quality of life in patients suffering from chemotherapy-induced or diabetic peripheral neuropathy.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 2
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Taichung
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Taichung, Taichung, Tajwan, 402306
- Chung Shan Medical University Hospital
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: leczenie
|
Daily topical application for 5 minutes over 7 days
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Norfolk Quality of Life Questionnaire-Diabetic Neuropathy (Norfolk QOL-DN) Score
Ramy czasowe: From baseline (Day 1) to the end of the treatment (Day 7).
|
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
Ramy czasowe: From baseline (Day 1) to the end of the treatment (Day 7).
|
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).
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Shiang-Suo Huang, PhD, Chung Shan Medical University
Publikacje i pomocne linki
Publikacje ogólne
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- CS2-25059
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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