Mint5
Research type
Research Study
Full title
A phase II RCT of topical menthol gel versus placebo in the treatment of chemotherapy induced peripheral neuropathic pain
IRAS ID
139424
Contact name
Marie Fallon
Contact email
Sponsor organisation
University of Edinburgh (ACCORD)
Eudract number
2013-003968-31
ISRCTN Number
ISRCTN69917256
Duration of Study in the UK
1 years, 3 months, 0 days
Research summary
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 we 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 and has the same texture as menthol but has no active drug. The gel will be applied twice a day for 4 weeks. Participants will be assessed for pain and its impact on function, mood and quality of life along with an fMRI scan before starting menthol treatment and after 4 weeks of treatment.
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, we 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 we conduct any future larger clinical trial.
REC name
Scotland B REC
REC reference
13/SS/0201
Date of REC Opinion
2 Dec 2013
REC opinion
Further Information Favourable Opinion