Active — Not RecruitingPhase 2

Topical Herbal Medicine for Chemotherapy-Induced Peripheral Neuropathy

Taiwan40 participantsStarted 2025-05-12

Plain-language 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.

Who can participate

Age range

20 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Numeric Rating Scale (NRS) of hypoesthesia

Timeframe: The NRS of hypoesthesia will be assessed at Baseline (Day 1), Day 14 (end of intervention), Day 21, and Day 28 (end of study).

Trial details

NCT IDNCT07693387

SponsorTaiwan Municipal An-Nan Hospital-China Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-31

View on ClinicalTrials.gov More Chemotherapy-induced Peripheral Neuropathy (CIPN) trials