Topical Herbal Medicine for Chemotherapy-Induced Peripheral Neuropathy
2026년 7월 3일 업데이트: Chien-Chen Huang, Taiwan Municipal An-Nan Hospital-China Medical University
Development of Topical Herbal Medicine to Alleviate Chemotherapy-Induced Peripheral Neuropathy: Basic Research and Clinical Trials
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.
연구 개요
상태
모집하지 않고 적극적으로
상세 설명
Our laboratory previously discovered a unique and simple-to-apply neuroprotective method involving topical menthol treatment.
In an animal model, this approach demonstrated prominent anti-inflammatory effects and improved behavioral outcomes (published in the Journal of Neuroinflammation, 2022).
Based on these findings, we hypothesize that topical menthol can alleviate chemotherapy-induced peripheral neuropathy (CIPN).To test this hypothesis, our team conducted a preliminary open-label clinical study (IRB: TMANH112-REC025) evaluating menthol-based gloves and foot-covers.
The pilot results revealed that the 8% menthol concentration significantly improved tactile sensation sensitivity via von Frey monofilament testing.
Notably, after a 14-day intervention, the therapeutic effects appeared to persist for up to 21 days.While the small sample size in the pilot stage limited the statistical power to detect significant differences in subjective symptoms like numbness (NRS) or overall quality of life, the trending improvements in physical tactile sensation warrant a rigorous validation.
Therefore, this expanded, randomized, double-blind, placebo-controlled trial is scientifically designed to provide adequate statistical power to confirm the sustained clinical efficacy and safety of 8% topical menthol treatment, while exploring underlying biological mechanisms through plasma-derived small extracellular vesicle biomarker analysis in CIPN patients.
연구 유형
중재적
등록 (추정된)
40
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Taiwan
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Tainan, Taiwan, 대만, 709
- An Nan Hospital, China Medical University
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 8% menthol group
Participants will undergo a two-week intervention, wearing the menthol gloves for five minutes once daily.
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Participants will undergo a two-week intervention, wearing the menthol gloves for five minutes once daily.
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가짜 비교기: sham menthol group
Participants will undergo a two-week intervention, wearing the sham menthol gloves for five minutes once daily.
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Participants will undergo a two-week intervention, wearing the sham menthol gloves for five minutes once daily.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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The Numeric Rating Scale (NRS) of hypoesthesia
기간: The NRS of hypoesthesia will be assessed at Baseline (Day 1), Day 14 (end of intervention), Day 21, and Day 28 (end of study).
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The NRS of hypoesthesia will be assessed at Baseline (Day 1), Day 14 (end of intervention), Day 21, and Day 28 (end of study).
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The Numeric Rating Scale (NRS) of dysesthesia
기간: The NRS of dysesthesia will be assessed at Baseline (Day 1), Day 14 (end of intervention), Day 21, and Day 28 (end of study).
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The NRS of dysesthesia will be assessed at Baseline (Day 1), Day 14 (end of intervention), Day 21, and Day 28 (end of study).
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The Numeric Rating Scale (NRS) of allodynia
기간: The NRS of allodynia will be assessed at Baseline (Day 1), Day 14 (end of intervention), Day 21, and Day 28 (end of study).
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The NRS of allodynia will be assessed at Baseline (Day 1), Day 14 (end of intervention), Day 21, and Day 28 (end of study).
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BPI-SF;the Brief Pain Inventory-Short Form
기간: BPI-SF will be assessed at Baseline (Day 1), Day 14 (end of intervention), and Day 28 (end of follow-up).
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Change from baseline in average pain severity and pain interference scores, as assessed by the Brief Pain Inventory-Short Form (BPI-SF).
The BPI-SF average pain severity score utilizes a 0-10 numeric rating scale, ranging from 0 (no pain) to 10 (worst pain), where higher scores indicate a greater degree of pain.
The BPI-SF also measures pain interference across seven daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life), with each item scored from 0 (no interference) to 10 (interferes completely).
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BPI-SF will be assessed at Baseline (Day 1), Day 14 (end of intervention), and Day 28 (end of follow-up).
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Von Frey Monofilament Test
기간: Von Frey Monofilament Test will be assessed at Baseline (Day 1), Day 14 (end of intervention), Day 21, and Day 28 (end of study).
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Von Frey monofilaments (Semmes-Weinstein von Frey Aesthesiometer, Stoelting Co., Wood Dale, IL, USA):a set of 20 von Frey monofilaments with evaluator size/target forces ranging from 1.65/0.008
g to 6.65/300 g.
Each monofilament was calibrated to a target force in grams (g) within a 5% standard deviation.
Measurement sites included the sole, tip of the big toe, palm, and tip of the middle finger.
All tests were performed by an independent assessor who was blinded to the allocation of randomization.
All the procedures followed the operation manual provided by the filament manufacturer.
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Von Frey Monofilament Test will be assessed at Baseline (Day 1), Day 14 (end of intervention), Day 21, and Day 28 (end of study).
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Functional Assessment of Cancer Therapy-General (FACT-G)
기간: FACT-G will be assessed at Baseline (Day 1), Day 14 (end of intervention), and Day 28 (end of follow-up).
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Change from baseline in health-related quality of life, as assessed by the 27-item FACT-G questionnaire.
Scoring and proration for missing items will be performed according to the official FACIT scoring guidelines.
The scale covers four primary domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being.
Each item is scored on a 5-point Likert scale ranging from 0 to 4, with higher total adjusted scores indicating better quality of life.
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FACT-G will be assessed at Baseline (Day 1), Day 14 (end of intervention), and Day 28 (end of follow-up).
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Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT-Ntx) Subscale
기간: FACT-Ntx will be assessed at Baseline (Day 1), Day 14 (end of intervention), and Day 28 (end of follow-up).
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Change from baseline in chemotherapy-induced peripheral neurotoxicity symptoms, as assessed by the 13-item FACT-Ntx subscale (part of the FACT/GOG-NTX-13 evaluation).
Scoring and proration for missing items will be performed according to the official FACIT scoring guidelines.
Each item is scored on a 5-point Likert scale ranging from 0 to 4, with higher total adjusted scores indicating fewer neurotoxicity symptoms and better neurological function.
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FACT-Ntx will be assessed at Baseline (Day 1), Day 14 (end of intervention), and Day 28 (end of follow-up).
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
- 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.
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 5월 12일
기본 완료 (추정된)
2027년 1월 31일
연구 완료 (추정된)
2027년 1월 31일
연구 등록 날짜
최초 제출
2026년 7월 3일
QC 기준을 충족하는 최초 제출
2026년 7월 3일
처음 게시됨 (실제)
2026년 7월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 3일
마지막으로 확인됨
2026년 7월 1일
추가 정보
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