Topical Herbal Medicine for Chemotherapy-Induced Peripheral Neuropathy
NCT07693387 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-07-09
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.
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.
Sponsors & Collaborators
-
China Medical University, Taiwan
collaborator OTHER -
Taiwan Municipal An-Nan Hospital-China Medical University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-12
- Primary Completion
- 2027-01-31
- Completion
- 2027-01-31
Countries
- Taiwan
Study Locations
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