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).

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.

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).