Topical Herbal Medicine for Chemotherapy-Induced Peripheral Neuropathy

NCT07693387 | Active Not Recruiting Phase 2

• 1 other identifier: TMANH113-REC021(AR-2)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Chemotherapy-induced peripheral neuropathy; Menthol; Neuropathic pain; small extracellular vesicles

Outcome Measures

Primary Outcomes (1)

• The Numeric Rating Scale (NRS) of hypoesthesia

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

Secondary Outcomes (6)

• The Numeric Rating Scale (NRS) of dysesthesia

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

• The Numeric Rating Scale (NRS) of allodynia

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

• BPI-SF;the Brief Pain Inventory-Short Form

  BPI-SF will be assessed at Baseline (Day 1), Day 14 (end of intervention), and Day 28 (end of follow-up).

• Von Frey Monofilament Test

  Von Frey Monofilament Test will be assessed at Baseline (Day 1), Day 14 (end of intervention), Day 21, and Day 28 (end of study).

• Functional Assessment of Cancer Therapy-General (FACT-G)

  FACT-G will be assessed at Baseline (Day 1), Day 14 (end of intervention), and Day 28 (end of follow-up).

Study Arms (2)

8% menthol group

EXPERIMENTAL

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

Drug: menthol-based hand and foot gloves

sham menthol group

SHAM COMPARATOR

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

Drug: Sham menthol-based hand and foot gloves

Interventions

menthol-based hand and foot gloves DRUG

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

8% menthol group

Sham menthol-based hand and foot gloves DRUG

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

sham menthol group

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. All adult cancer patients (Age≧20-year-old) who received chemotherapy regimens, including adjuvant and neoadjuvant therapy.
• \. Stage I-IV cancer patients.
• \. Who received chemotherapy regimens, including Taxanes (paclitaxel or docetaxel), platinum (cisplatin, oxaliplatin, carboplatin).
• \. Who have received two cycle or have completed the neurotoxic chemotherapy regimen(24).
• \. Baseline von Frey Monofilament test (Target force at hand) ≧ 0.07gms.
• \. Baseline von Frey Monofilament test (Target force at foot) ≧ 0.4gms.
• \. Eastern Cooperative Oncology Group (ECOG) performance status ≦3.
• \. Grading of peripheral sensory neuropathy in National Cancer Institute- common terminology criteria for adverse events,v5.0 (NCI-CTCAE5) ≧1.
• \. Written patient informed consent.
• \. 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).

You may not qualify if:

• \. Uncontrolled Diabetic Mellitus, HbA1c≧7% is inappropriate(25).
• \. Diabetic neuropathy diagnosed before receiving chemotherapy.
• \. Neuropathy from any type of nerve compression (e.g., carpal/tarsal tunnel syndrome, radiculopathy, spinal stenosis, brachial plexopathy).
• \. 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).
• \. Limb trauma that has resulted in vascular and nerve damage.
• \. Individuals with severe mental illness or cognitive impairments who are unable to provide informed consent.
• \. Severe hemorrhagic coagulopathy or bleeding tendency.
• \. Unstable cardiovascular disease.
• \. Severe skin lesions around the treatment sites.
• \. Pregnant and breastfeeding women.
• \. Participants who are concurrently enrolled in additional clinical trials.
• \. Individuals allergic to topical menthol.
• \. Adults weighing less than 50 kilograms.
• \. The researchers will exclude any participants considered to be inappropriate for the study.
• \. Profound weight loss (\>5% to 10% of body weight).

Sponsors & Collaborators

• Taiwan Municipal An-Nan Hospital-China Medical University: lead
• China Medical University, Taiwan: collaborator

Study Sites (1)

An Nan Hospital, China Medical University

Tainan, Taiwan, 709, Taiwan

Location

Related Publications (3)

• Colvin LA. Chemotherapy-induced peripheral neuropathy: where are we now? Pain. 2019 May;160 Suppl 1(Suppl 1):S1-S10. doi: 10.1097/j.pain.0000000000001540.

  PMID: 31008843 BACKGROUND

• Smith EM, Pang H, Cirrincione C, Fleishman S, Paskett ED, Ahles T, Bressler LR, Fadul CE, Knox C, Le-Lindqwister N, Gilman PB, Shapiro CL; Alliance for Clinical Trials in Oncology. Effect of duloxetine on pain, function, and quality of life among patients with chemotherapy-induced painful peripheral neuropathy: a randomized clinical trial. JAMA. 2013 Apr 3;309(13):1359-67. doi: 10.1001/jama.2013.2813.

  PMID: 23549581 BACKGROUND

• Park SB, Goldstein D, Krishnan AV, Lin CS, Friedlander ML, Cassidy J, Koltzenburg M, Kiernan MC. Chemotherapy-induced peripheral neurotoxicity: a critical analysis. CA Cancer J Clin. 2013 Nov-Dec;63(6):419-37. doi: 10.3322/caac.21204.

  PMID: 24590861 BACKGROUND

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., PhD

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 9, 2026
• Study Start: May 12, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: July 9, 2026

Record last verified: 2026-07

Locations

TW (1)