The MePFAC study has been designed in response to a commissioning brief from the National Institute for Health Research - Health Technology Assessment Programme and will run from 2017 to 2022
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 may have some benefit, but the evidence is not clear.
The study aims to estimate clinical effectiveness of methylphenidate versus placebo in the treatment of cancer-related fatigue in patients receiving specialist palliative care.
Using a randomised controlled trial design, the MePFAC study aims to recruit 230 patients across ten sites in England between 2018 and 2022. Feasibility of recruitment strategy, randomisation and follow-up will be evaluated during a pilot phase at four sites during the first nine months of recruitment.
We will recruit adult patients with advanced incurable cancer of all tumour types, with moderate or severe fatigue. These patients will receive nine weeks' treatment with methylphenidate or placebo. Patients will start at a dose of 5mg twice daily and depending on response and side effects, the dose will be adjusted over the telephone or at outpatient appointments.
The primary outcome is fatigue at 6 weeks measured by the fatigue subscale of Functional Assessment of Chronic Illness Therapy (FACIT-F). Secondary outcomes include other measures of quality of life, adverse events, activities of daily living, appetite, satisfaction of patients and carers, survival, and need for other medication.