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ACTIVE NOT RECRUITING

NCT07693387

PHASE2

Topical Herbal Medicine for Chemotherapy-Induced Peripheral Neuropathy

Sponsor: Taiwan Municipal An-Nan Hospital-China Medical University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if menthol works to relieve chronic neuropathic pain and chemotherapy-induced peripheral neuropathy (CIPN). The primary objectives are to evaluate the safety and clinical efficacy of menthol-containing gloves and foot-covers, specifically whether they can improve patient-reported hypoesthesia (numbness). Secondary objectives include assessing the sustained effects on pain, dysesthesia (abnormal sensations), allodynia (touch-induced pain), and overall quality of life. Additionally, this study will include an exploratory lab analysis using blood samples to investigate potential biological markers (small extracellular vesicles and microRNA) associated with treatment responses. Participants will be asked to: Wear menthol-containing gloves and foot-covers (or shams) daily for 5 minutes per session over a 14-day period. Attend clinic visits on Days 1, 14, 21, and 28 for evaluations and tests.

Official title: Development of Topical Herbal Medicine to Alleviate Chemotherapy-Induced Peripheral Neuropathy: Basic Research and Clinical Trials

Key Details

Gender

All

Age Range

20 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-05-12

Completion Date

2027-01-31

Last Updated

2026-07-09

Healthy Volunteers

Conditions

Chemotherapy-induced Peripheral Neuropathy (CIPN)

Interventions

DRUG

menthol-based hand and foot gloves

Participants will undergo a two-week intervention, wearing the menthol gloves for five minutes once daily.

DRUG

Sham menthol-based hand and foot gloves

Participants will undergo a two-week intervention, wearing the sham menthol gloves for five minutes once daily.

Inclusion Criteria: * 1\. All adult cancer patients (Age≧20-year-old) who received chemotherapy regimens, including adjuvant and neoadjuvant therapy. * 2\. Stage I-IV cancer patients. * 3\. Who received chemotherapy regimens, including Taxanes (paclitaxel or docetaxel), platinum (cisplatin, oxaliplatin, carboplatin). * 4\. Who have received two cycle or have completed the neurotoxic chemotherapy regimen(24). * 5\. Baseline von Frey Monofilament test (Target force at hand) ≧ 0.07gms. * 6\. Baseline von Frey Monofilament test (Target force at foot) ≧ 0.4gms. * 7\. Eastern Cooperative Oncology Group (ECOG) performance status ≦3. * 8\. Grading of peripheral sensory neuropathy in National Cancer Institute- common terminology criteria for adverse events,v5.0 (NCI-CTCAE5) ≧1. * 9\. Written patient informed consent. * 10\. Discontinue analgesics or maintain the same dosage throughout the study period. (e.g., duloxetine, or another analgesia, including Pregabalin, Venlafaxine, Minocycline, Topical gel, Oxycodone, Naloxone, Cannabinoids). Exclusion Criteria: * 1\. Uncontrolled Diabetic Mellitus, HbA1c≧7% is inappropriate(25). * 2\. Diabetic neuropathy diagnosed before receiving chemotherapy. * 3\. Neuropathy from any type of nerve compression (e.g., carpal/tarsal tunnel syndrome, radiculopathy, spinal stenosis, brachial plexopathy). * 4\. Other diseases that cause peripheral neuropathy (e.g., Severe chronic kidney disease, hepatitis, thyroid disorders, vitamin B12 deficiency, viral infections such as HIV and syphilis, alcohol poisoning, inflammatory diseases such as chronic demyelinating polyneuropathy, heavy metal poisoning, hereditary neuropathies). * 5\. Limb trauma that has resulted in vascular and nerve damage. * 6\. Individuals with severe mental illness or cognitive impairments who are unable to provide informed consent. * 7\. Severe hemorrhagic coagulopathy or bleeding tendency. * 8\. Unstable cardiovascular disease. * 9\. Severe skin lesions around the treatment sites. * 10\. Pregnant and breastfeeding women. * 11\. Participants who are concurrently enrolled in additional clinical trials. * 12\. Individuals allergic to topical menthol. * 13\. Adults weighing less than 50 kilograms. * 14\. The researchers will exclude any participants considered to be inappropriate for the study. * 15\. Profound weight loss (\>5% to 10% of body weight).

Locations (1)

An Nan Hospital, China Medical University

Tainan, Taiwan, Taiwan