Chemotherapy-induced Peripheral Neuropathy (CIPN)Phase 2NCT07693387
Topical Herbal Medicine for Chemotherapy-Induced Peripheral Neuropathy
A Phase 2 study testing menthol-based hand and foot gloves in people with Chemotherapy-induced Peripheral Neuropathy (CIPN), run by Taiwan Municipal An-Nan Hospital-China Medical University at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy (CIPN)
- What is being tested?
- menthol-based hand and foot gloves
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 May 2025to 31 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- menthol-based hand and foot gloves, Sham menthol-based hand and foot gloves
- Keywords
- Chemotherapy-induced peripheral neuropathy, Menthol, Neuropathic pain, small extracellular vesicles
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
menthol-based hand and foot glovesDrug
Participants will undergo a two-week intervention, wearing the menthol gloves for five minutes once daily.
Sham menthol-based hand and foot glovesDrug
Participants will undergo a two-week intervention, wearing the sham menthol gloves for five minutes once daily.
| Study group | Role | What they receive |
|---|---|---|
| 8% menthol group | Experimental | Participants will undergo a two-week intervention, wearing the menthol gloves for five minutes once daily. Receives: 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. Receives: Drug: Sham menthol-based hand and foot gloves |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Numeric Rating Scale (NRS) of hypoesthesia
Measured: 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
Measured: 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
Measured: 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
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).
Measured: 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 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.
Measured: 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)
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.
Measured: FACT-G will be assessed at Baseline (Day 1), Day 14 (end of intervention), and Day 28 (end of follow-up).
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT-Ntx) Subscale
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.
Measured: FACT-Ntx will be assessed at Baseline (Day 1), Day 14 (end of intervention), and Day 28 (end of follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start12 May 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Peripheral Neuropathy (CIPN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taiwan Municipal An-Nan Hospital-China Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- China Medical University, Taiwan
- Responsible party
- Principal investigator, Chien-Chen Huang, Taiwan Municipal An-Nan Hospital-China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693387
- Sponsor's protocol ID
- TMANH113-REC021(AR-2)
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31008843Smith 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.
PubMed 23549581Park 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.
PubMed 24590861
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Topical Herbal Medicine to Alleviate Chemotherapy-Induced Peripheral Neuropathy: Basic Research and Clinical Trials
- ClinicalTrials.gov ID
- NCT07693387
- Acronym / sponsor ID
- TMANH113-REC021(AR-2)
- Keywords
- Chemotherapy-induced peripheral neuropathy, Menthol, Neuropathic pain, small extracellular vesicles
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Taiwan Municipal An-Nan Hospital-China Medical UniversityUniversity, hospital or other
- Collaborators
- China Medical University, Taiwan
- Study start
- 12 May 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 8% menthol group | Experimental | Drug: menthol-based hand and foot glovesParticipants will undergo a two-week intervention, wearing the menthol gloves for five minutes once daily. |
| sham menthol group | Sham comparator | Drug: Sham menthol-based hand and foot glovesParticipants will undergo a two-week intervention, wearing the sham menthol gloves for five minutes once daily. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| menthol-based hand and foot glovesParticipants will undergo a two-week intervention, wearing the menthol gloves for five minutes once daily. | Drug | 8% menthol group |
| Sham menthol-based hand and foot glovesParticipants will undergo a two-week intervention, wearing the sham menthol gloves for five minutes once daily. | Drug | sham menthol group |
Primary outcome
The Numeric Rating Scale (NRS) of hypoesthesia
Time frame: The NRS of hypoesthesia will be assessed at Baseline (Day 1), Day 14 (end of intervention), Day 21, and Day 28 (end of study).
6 secondary outcomes
The Numeric Rating Scale (NRS) of dysesthesia
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: FACT-G will be assessed at Baseline (Day 1), Day 14 (end of intervention), and Day 28 (end of follow-up).
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT-Ntx) Subscale
Time frame: FACT-Ntx will be assessed at Baseline (Day 1), Day 14 (end of intervention), and Day 28 (end of follow-up).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Background: PubMed 31008843Colvin 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.
- Background: PubMed 23549581Smith 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.
- Background: PubMed 24590861Park 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing menthol-based hand and foot gloves in people with Chemotherapy-induced Peripheral Neuropathy (CIPN), run by Taiwan Municipal An-Nan Hospital-China Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Numeric Rating Scale (NRS) of hypoesthesia (time frame: The NRS of hypoesthesia will be assessed at Baseline (Day 1), Day 14 (end of intervention), Day 21, and Day 28 (end of study).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07693387, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.