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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
52
Application of gel for 6 weeks.
Western General Hospital
Edinburgh, United Kingdom
Western General Hospital
Edinburgh, United Kingdom
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.
Time frame: 6 weeks
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)
Time frame: 6 weeks
Treatment effect on quality of life functions
Changes in EORTC QLC-c30 scores (30 symptoms on same scale as CIPN)
Time frame: 6 weeks
Treatment effect on pain scores
Changes in Brief Pain Inventory - Short Form scores (13 symptoms rated from 0 None to 10 Worst)
Time frame: 6 weeks
Treatment effect on anxiety and depression
Changes in Hospital Anxiety and Depression Scale (HADS) scores
Time frame: 6 weeks (14 symptoms rated from 0 to 3 in severity)
Treatment effect on pain catastrophisation
Changes in Pain Catastrophising Scale (PCS) scores
Time frame: 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)
Time frame: 6 weeks
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Treatment effect on physical activity
Changes in Actigraph data (measures of step counts, amount of moderate/vigorous activity and sleep times/efficiency)
Time frame: 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)
Time frame: 6 weeks