Menthol In Neuropathy Trial

NCT04276727 | Completed Phase 2 DMC

• 1 other identifier: MINT
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

Patients will be recruited who have peripheral neuropathy due to chemotherapy. They will be given a blinded treatment of gel containing either menthol (3%) or placebo to be applied for 6 weeks, twice a day. Assessments of pain, neuropathic symptoms and impact on quality of life will be done at baseline, 6 weeks and 12 weeks. Functional magnetic resonance imaging (fMRI) scans will be done at baseline and 6 weeks. Physical activity data will also be collected to be analysed in conjunction with pain assessments.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Keywords

CIPN; Peripheral neuropathy; Chemotherapy; Neuropathic pain

Outcome Measures

Primary Outcomes (1)

• Reduction in CIPN symptoms

  A clinically significant reduction in pain (at least a 30% decrease in total BPI SF score as relates to the index neuropathic pain) between baseline and 6 weeks.

  6 weeks

Secondary Outcomes (8)

• Treatment effect on Chemotherapy Induced Peripheral Neuropathy

  6 weeks

• Treatment effect on quality of life functions

  6 weeks

• Treatment effect on pain scores

  6 weeks

• Treatment effect on anxiety and depression

  6 weeks (14 symptoms rated from 0 to 3 in severity)

• Treatment effect on pain catastrophisation

  6 weeks (13 questions rated from 0-4 in severity)

Other Outcomes (9)

• Changes in Functional Magnetic Imaging data

  6 weeks

• Post treatment changes in CIPN

  12 weeks (from baseline)

• Post treatment changes in quality of life measures

  12 weeks (from baseline)

Study Arms (2)

Menthol

ACTIVE COMPARATOR

Menthol gel to be applied twice a day for 6 weeks - toes to knees, fingertips to elbows, top and base of spine.

Drug: MINT study IMP

Placebo

PLACEBO COMPARATOR

Placebo gel to be applied twice a day for 6 weeks - toes to knees, fingertips to elbows, top and base of spine.

Drug: MINT study IMP

Interventions

MINT study IMP DRUG

Application of gel for 6 weeks.

Menthol; Placebo

Eligibility Criteria

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

You may qualify if:

• Patients have received any neurotoxic chemotherapy.
• Patients have experienced post treatment Chemotherapy Induced Peripheral Neuropathy (CIPN) pain for a minimum of 3 months after completing chemotherapy.
• Patients reporting a distressing or uncomfortable neuropathic symptom (such as pain or tingling) with an average score in the last 24 hours of ≥5 on a scale of 0-10 with 0 being none, according to the Numeric Rating Scale for pain.
• Aged 18 years or over at study entry.
• Patient's Oncology team agrees to their taking part in the study.
• Patients are able to provide written informed consent to participation in the study after explanation of the study protocol.
• In the opinion of the investigator, the patient is able to complete the various assessments.
• Neuropathy must be confined to the distal extremities (distal to elbows and/or knees).

You may not qualify if:

• Pre-existing or history of peripheral neuropathy due to any cause other than chemotherapy (diabetes, alcohol, toxin, hereditary, etc.).
• Patients with any contraindication to the use of topical therapy or menthol.
• Neurological conditions which may influence findings (such as Multiple Sclerosis or residual signs/symptoms from a previous stroke).
• Skin conditions which prevent assessment of the relevant areas affected by peripheral neuropathy.
• Suffering from significant psychiatric illness, which would hinder their completion of the study in the opinion of the investigator.
• General medical condition is unstable or rapidly deteriorating, such that they are unlikely to be able to contribute to the study.
• In the opinion of the Research Team or their usual medical team, would be unable to complete the study protocol for any other reason.
• Current treatment of ≤ 30 days duration with topical lidocaine patch/gel or anticonvulsants, tricyclic antidepressants, MAO inhibitor, or other neuropathic pain medication agents such as carbamazepine, phenytoin, valproic acid, gabapentin/pregabalin, lamotrigine or amifostine. (If on the same dose of any of these medications for \>31 days, patients will be asked to continue these for the duration of the study. Analgesic agents such as acetaminophen, nonsteroidal anti-inflammatory agents, or opioids, are allowed if on the same doses for \>31 days).
• Application of capsaicin cream or patch (to the limb extremities) currently or within the last 30 days (as this would interfere with application of the menthol gel and potentially study outcome).
• Patients with significant pain other than CIPN (ie pain worse than the CIPN).
• Other medical conditions, which in the opinion of the treating physician/allied health professional would make this protocol unreasonably hazardous for the patient.
• Participants previously randomised into this study.
• Participants not prepared to stop using any other physical activity meter.
• Co-enrolment in any other pain treatment studies.

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (2)

Western General Hospital

Edinburgh, EH4 2XR, United Kingdom

Location

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Neuralgia

Condition Hierarchy (Ancestors)

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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Gel tubes will be supplied with similar labelling, identified by blinded drug pack numbers which can be linked to the treatment allocation if an emergency need arises. The menthol and placebo gels have a similar blue colour and both have a minty odour.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, double-blind placebo controlled

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: February 19, 2020
• Study Start: November 4, 2019
• Primary Completion: March 24, 2022
• Study Completion: March 24, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)