Chemotherapy-induced Peripheral NeuropathyPhase 2MINTNCT04276727
Menthol In Neuropathy Trial
A Phase 2 study testing MINT study IMP in people with Chemotherapy-induced Peripheral Neuropathy, run by University of Edinburgh at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- MINT study IMP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 4 Nov 2019to 24 Mar 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Western General Hospital
Edinburgh, EH4 2XR
Western General Hospital
Edinburgh, EH4 2XU
About this study
Official title: A Phase II RCT of Topical Menthol Gel Versus Placebo in the Treatment of Chemotherapy Induced Peripheral Neuropathic Pain
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.
Read the detailed description
Modern cancer treatments, while more effective at prolonging life, are associated with some long lasting effects, especially nerve pain. This occurs in up to 90% of patients and 50% of patients still experience nerve pain a year after treatment. Not only is this distressing in itself but the investigators now understand that this treatment-related pain is exacerbating other pains, making cancer pain more difficult to control. The problem with managing nerve pain caused by treatment is that there is no predictable and effective treatment.
Our team has discovered that menthol cream or gel applied to the skin in the area of nerve pain can be effective. This trial seeks to provide better evidence of using this simple, cheap, non-toxic treatment. Participants will be given either menthol gel to the affected area or a placebo gel which smells, looks like and has the same texture as menthol but has no active drug. The gel will be applied twice a day for 6 weeks.
Participants will initially be assessed for pain and its impact on function, mood and quality of life and, if possible, will also have an fMRI scan immediately before starting menthol treatment and after 6 weeks of treatment. They will also have some assessments a further 6 weeks after treatment finishes. As part of impact on function assessment, participants will be asked to wear a physical activity monitor for a few days prior to each of the three main assessment points.
Our group has used special scans of the brain called fMRI to help identify if a treatment has real potential for patients. Sometimes, in early studies of a new treatment, patients can believe that the treatment has a real effect, but in fact it is a placebo effect. FMRI scans in this study will help to identify if menthol gel is having a true pain relieving effect, by comparing the patient's reports of pain with their scan findings. This will be very helpful in aiding the decision of how the research team conduct any future larger clinical trial.
- Being tested
- MINT study IMP
- Keywords
- CIPN, Peripheral neuropathy, Chemotherapy, Neuropathic pain
- Medical subject headings
- Peripheral Nervous System Diseases, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MINT study IMPDrug
Application of gel for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: MINT study IMP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (8)
Treatment effect on Chemotherapy Induced Peripheral Neuropathy
Changes in EORTC QLQ (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires) CIPN-20 (severity of 20 symptoms rated on 4 point scale from Not at all to Very much)
Measured: 6 weeks
Treatment effect on quality of life functions
Changes in EORTC QLC-c30 scores (30 symptoms on same scale as CIPN)
Measured: 6 weeks
Treatment effect on pain scores
Changes in Brief Pain Inventory - Short Form scores (13 symptoms rated from 0 None to 10 Worst)
Measured: 6 weeks
Treatment effect on anxiety and depression
Changes in Hospital Anxiety and Depression Scale (HADS) scores
Measured: 6 weeks (14 symptoms rated from 0 to 3 in severity)
Treatment effect on pain catastrophisation
Changes in Pain Catastrophising Scale (PCS) scores
Measured: 6 weeks (13 questions rated from 0-4 in severity)
Treatment effect on side effects
Changes in side effects (Yes/No to any SEs, description of SE to be given)
Measured: 6 weeks
Treatment effect on physical activity
Changes in Actigraph data (measures of step counts, amount of moderate/vigorous activity and sleep times/efficiency)
Measured: 6 weeks
Perceived effects of IMP
Changes in perceived effects questions (How long participant thinks treatment takes to take effect and how long it lasts for)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start4 Nov 2019
- Primary completion24 Mar 2022
- Study completion24 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies 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
- Model description
- Randomised, double-blind placebo controlled
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276727
- Sponsor's protocol ID
- MINT
- Acronym
- MINT
- Status last verified
- Sep 2022
- First submitted
- 8 Nov 2019
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anyone interested in secondary analysis of the data should contact the Chief Investigator in the first instance.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II RCT of Topical Menthol Gel Versus Placebo in the Treatment of Chemotherapy Induced Peripheral Neuropathic Pain
- ClinicalTrials.gov ID
- NCT04276727
- Acronym / sponsor ID
- MINT / MINT
- Keywords
- CIPN, Peripheral neuropathy, Chemotherapy, Neuropathic pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 24 Mar 2022 (actual)
- Study completion
- 24 Mar 2022 (actual)
- First posted
- 19 Feb 2020 (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.
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.
Detailed description
Modern cancer treatments, while more effective at prolonging life, are associated with some long lasting effects, especially nerve pain. This occurs in up to 90% of patients and 50% of patients still experience nerve pain a year after treatment. Not only is this distressing in itself but the investigators now understand that this treatment-related pain is exacerbating other pains, making cancer pain more difficult to control. The problem with managing nerve pain caused by treatment is that there is no predictable and effective treatment.
Our team has discovered that menthol cream or gel applied to the skin in the area of nerve pain can be effective. This trial seeks to provide better evidence of using this simple, cheap, non-toxic treatment. Participants will be given either menthol gel to the affected area or a placebo gel which smells, looks like and has the same texture as menthol but has no active drug. The gel will be applied twice a day for 6 weeks.
Participants will initially be assessed for pain and its impact on function, mood and quality of life and, if possible, will also have an fMRI scan immediately before starting menthol treatment and after 6 weeks of treatment. They will also have some assessments a further 6 weeks after treatment finishes. As part of impact on function assessment, participants will be asked to wear a physical activity monitor for a few days prior to each of the three main assessment points.
Our group has used special scans of the brain called fMRI to help identify if a treatment has real potential for patients. Sometimes, in early studies of a new treatment, patients can believe that the treatment has a real effect, but in fact it is a placebo effect. FMRI scans in this study will help to identify if menthol gel is having a true pain relieving effect, by comparing the patient's reports of pain with their scan findings. This will be very helpful in aiding the decision of how the research team conduct any future larger clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised, double-blind placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Menthol | Active comparator | Drug: MINT study IMPMenthol gel to be applied twice a day for 6 weeks - toes to knees, fingertips to elbows, top and base of spine. |
| Placebo | Placebo comparator | Drug: MINT study IMPPlacebo gel to be applied twice a day for 6 weeks - toes to knees, fingertips to elbows, top and base of spine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
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 |
|---|---|---|
| MINT study IMPApplication of gel for 6 weeks. | Drug | Menthol, Placebo |
Primary outcome
Reduction in CIPN symptoms
Time frame: 6 weeks
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.
8 secondary outcomes
Treatment effect on Chemotherapy Induced Peripheral Neuropathy
Time frame: 6 weeks
Treatment effect on quality of life functions
Time frame: 6 weeks
Treatment effect on pain scores
Time frame: 6 weeks
Treatment effect on anxiety and depression
Time frame: 6 weeks (14 symptoms rated from 0 to 3 in severity)
Treatment effect on pain catastrophisation
Time frame: 6 weeks (13 questions rated from 0-4 in severity)
Treatment effect on side effects
Time frame: 6 weeks
Treatment effect on physical activity
Time frame: 6 weeks
Perceived effects of IMP
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Individual participant dataSharing planned: No. Anyone interested in secondary analysis of the data should contact the Chief Investigator in the first instance.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MINT study IMP in people with Chemotherapy-induced Peripheral Neuropathy, run by University of Edinburgh at 2 sites in United Kingdom.
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 8 inclusion and 14 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: finished, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction in CIPN symptoms (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2022.