A phase II randomised, double blind controlled exploratory functional magnetic resonance imaging (fMRI) study of menthol gel versus placebo in the treatment of chemotherapy induced peripheral neuropathy (CIPN) 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. Chief Investigator: Professor Marie Fallon Number and location of participating sites / geographical scope (by region/ country) Single site, NHS Lothian EudraCT number 2013-003968-31 Funder: Marie Curie Cancer Care Start and End date Of grant award: 1 Sep 2018 - 31 Aug 2020 Of recruitment: Recruitment started November 2019 Current status: Completed Trial Unblinding Information: In circumstances where unblinding is necessary please refer to the protocol and follow instructions provided. Sponsor: ACCORD https://www.accord.scot/ Chief Investigator: Professor Marie Fallon Institute of Genetics and Molecular Medicine University of Edinburgh Crewe Road South Edinburgh EH4 2XR Email: marie.fallon@ed.ac.uk Trial Manager: Lucy Norris - Email lucy.norris@ed.ac.uk UK GDPR privacy statement: provided at recruitment ECTU Involvement: Statistics and Database Image This article was published on 2024-09-24
