Topical Herbal Medicine for Chemotherapy-Induced Peripheral Neuropathy
3 luglio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Attivo, non reclutante
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
40
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Taiwan
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Tainan, Taiwan, Taiwan, 709
- An Nan Hospital, China Medical University
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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).
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Comparatore fittizio: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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The Numeric Rating Scale (NRS) of hypoesthesia
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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The Numeric Rating Scale (NRS) of dysesthesia
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
12 maggio 2025
Completamento primario (Stimato)
31 gennaio 2027
Completamento dello studio (Stimato)
31 gennaio 2027
Date di iscrizione allo studio
Primo inviato
3 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
3 luglio 2026
Primo Inserito (Effettivo)
9 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
9 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
3 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- TMANH113-REC021(AR-2)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .