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TRPM8 Activators for Peripheral Neuropathy

12. maj 2026 opdateret af: SHIANG-SUO HUANG

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).

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Taichung
      • Taichung, Taichung, Taiwan, 402306
        • Chung Shan Medical University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. 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).
  2. Diabetic patients aged 20 years or older who have clinical features of diabetic peripheral neuropathy (DPN).
  3. Patients who meet criteria 1 or 2, are willing to participate, and are able to sign an informed consent form.

Exclusion Criteria:

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: behandling
Daily topical application for 5 minutes over 7 days

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Norfolk Quality of Life Questionnaire-Diabetic Neuropathy (Norfolk QOL-DN) Score
Tidsramme: 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
Tidsramme: 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).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Shiang-Suo Huang, PhD, Chung Shan Medical University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

3. november 2025

Primær færdiggørelse (Faktiske)

7. april 2026

Studieafslutning (Anslået)

1. juni 2026

Datoer for studieregistrering

Først indsendt

7. maj 2026

Først indsendt, der opfyldte QC-kriterier

7. maj 2026

Først opslået (Faktiske)

13. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2026

Sidst verificeret

1. maj 2026

Mere information

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