Active, not recruiting
Phase 2
Topical Herbal Medicine for Chemotherapy-Induced Peripheral Neuropathy
Condition(s) studied
Chemotherapy-induced Peripheral Neuropathy (CIPN)
Investigational drug(s) / intervention(s)
menthol-based hand and foot glovesSham menthol-based hand and foot gloves
menthol-based hand and foot gloves: Participants will undergo a two-week intervention, wearing the menthol gloves for five minutes once daily.
Sham menthol-based hand and foot gloves: Participants will undergo a two-week intervention, wearing the sham menthol gloves for five minutes once daily.
Study 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.
Eligibility
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).
Primary outcome measure(s)
- 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).
Trial sites (1)
| Facility | City | Region | Status |
|---|
| An Nan Hospital, China Medical University |
Tainan |
Taiwan |
|
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