MePFAC
Research type
Research Study
Full title
Methylphenidate versus placebo for fatigue in advanced cancer (MePFAC)
IRAS ID
215297
Contact name
Patrick Stone
Contact email
Sponsor organisation
UCL Priment Clinical Trials Unit
Eudract number
2017-001950-33
Duration of Study in the UK
3 years, 5 months, 31 days
Research summary
Research summary
Patients with cancer often experience fatigue which can affect their ability to look after themselves and reduce their quality of life. Previous studies have suggested that the drug methylphenidate [MPH] may have some benefits, but the evidence is not clear.Patients with secondary cancer and fatigue will be invited to participate. If they agree they will receive nine weeks’ treatment with MPH or placebo (an inactive “dummy” pill). Which treatment people receive will be determined randomly by computer to ensure that our study is a “fair test”. The tablets will be made to appear identical so that neither the patient nor the staff knows which treatment is being used. Patients will be telephoned by a research nurse every week to advise them about which dose of study medication to take. At the start of the study, after three, six and nine weeks, patients will be seen face-to-face at an outpatient appointment, reassessed and asked to complete some questionnaires about their fatigue, their quality of life, a blood pressure check and to be re-supplied with medication.
Everyone will start on the lowest dose of the study medication. The dose will be adjusted over the telephone or at outpatient appointments, depending on response and side effects. All participants will be seen at the end of the study to ask how fatigued they feel, about their quality of life and about any side-effects. This will allow us to quantify the longer term benefits and side-effects of treatment.
After nine weeks the study will be finished. At that point usual clinical care will be resumed. Medical staff will be at liberty to use methylphenidate or any other treatment to help with fatigue dependent upon clinical circumstances.
Summary of results
Fatigue is a common and distressing symptom experienced by patients with advanced cancer receiving palliative care, for which there are very few treatments available. Methylphenidate is a stimulant medicine which some previous studies suggested might help cancer-related fatigue. We undertook a randomized controlled trial to compare the effects of methylphenidate or placebo (an inactive dummy pill) on cancer-related fatigue and the frequency of side-effects. We enrolled 162 patients with advanced cancer and fatigue at 17 different centres (hospital, hospices and community services) to participate in the trial. They were randomly allocated to receive either methylphenidate or placebo tablets. The number of tablets was adjusted each week over the first six weeks of the trial (depending on response and/or the presence of side-effects). Each week participants were either contacted by telephone or seen at face-to-face appointments to check on their well-being, response to treatment and side-effects. After six weeks the dose remained the same for a further two weeks, then was reduced for a further week then stopped altogether for the final week of the trial. After 6 (± 2) weeks of treatment we found that people given methylphenidate had a small improvement in fatigue that was not statistically important and that was too small to be considered helpful. Participants given methylphenidate reported some improvements in fatigue at other times (weeks 2-6 and week 8) that may not be explained by chance, but which were nonetheless still not large enough to be considered clinically important. There was no difference in the frequency of serious (life-threatening) side-effects or death in the two groups. Nor were there any major differences in the frequency of other (mild, moderate or severe) side-effects. On the basis of this trial, methylphenidate is not recommended for use as a treatment of fatigue in patients with advanced cancer.REC name
London - City & East Research Ethics Committee
REC reference
17/LO/0871
Date of REC Opinion
19 Jul 2017
REC opinion
Further Information Favourable Opinion