Methylphenidate Versus Placebo for Treating Fatigue in Patients With Advanced Cancer: Randomized, Double-Blind, Multicenter, Placebo-Controlled Trial

Author:

Stone Patrick Charles1ORCID,Minton Ollie2,Richardson Alison3ORCID,Buckle Peter1ORCID,Enayat Zinat E.1,Marston Louise4ORCID,Freemantle Nick5

Affiliation:

1. Marie Curie Palliative Care Research Department, Division of Psychiatry, University College London (UCL), London, United Kingdom

2. University Hospitals Sussex NHS Foundation Trust, Worthing Hospital, Lyndhurst Road, Worthing, West Sussex, United Kingdom

3. University of Southampton & University Hospital Southampton NHS Foundation Trust, Southampton General Hospital, Southampton, United Kingdom

4. Department of Primary Care & Population Health, Institute of Epidemiology & Health Care, Faculty of Population Health Sciences, University College London (UCL), London, United Kingdom

5. Comprehensive Clinical Trials Unit, University College London (UCL), London, United Kingdom

Abstract

PURPOSE To compare effects and side effects of 6 weeks of individually dose-titrated methylphenidate or placebo on fatigue in palliative care patients with advanced cancer. METHODS This is a randomized, double-blind, placebo-controlled, multicenter trial. Eligible patients had advanced incurable cancer and fatigue >3/10. Principal exclusions were hypertension; psychiatric, cardiovascular, cerebrovascular, renal, liver, or blood disorders; substance dependency; and epilepsy. Patients were randomly assigned 1:1 methylphenidate or placebo starting at 5 mg twice daily. Dose of methylphenidate/placebo was titrated once per week, over 6 weeks, up to a maximum of 20 mg three times daily. Trial ended at 10 weeks. Primary outcome was the difference in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) scores between groups at 6 ± 2 weeks. Secondary outcomes included adverse effects, quality of life, and mood. RESULTS One hundred sixty-two patients (73 men; mean, 65.8; standard deviation [SD], 10.3 years) were randomly assigned, and three were excluded from analysis. Seventy-seven were allocated placebo (baseline FACIT-F = 22 [SD, 10]); 82 were allocated methylphenidate (FACIT-F = 20 [SD, 9]). After 6 ± 2 weeks, FACIT-F scores were 1.97 points (95% CI, –0.95 to 4.90; P = .186) higher (better) on methylphenidate than placebo. Across 10 weeks of the study, FACIT-F was nominally higher in the methylphenidate group versus placebo (Diff, 2.20 [95% CI, 0.39 to 4.01]), but this did not reach the minimally clinically important difference (5-points). At 6 weeks, there were no differences between groups in quality-of-life or symptom domains except for depression scores (nominally reduced in the methylphenidate group: Diff, –1.35 [95% CI, –2.41 to –0.30]). There were no differences in mortality or serious adverse events. CONCLUSION After 6 ± 2 weeks of treatment, methylphenidate was not superior to placebo for treating fatigue in advanced cancer. Methylphenidate was safe and well-tolerated.

Publisher

American Society of Clinical Oncology (ASCO)

Cited by 1 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

1. Putting Methylphenidate for Cancer-Related Fatigue to Rest?;Journal of Clinical Oncology;2024-07-10

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