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Methylphenidate vs Placebo for Treating Fatigue in Patients With Advanced Cancer
abstract
This abstract is available on the publisher's site.
Access this abstract nowPURPOSE
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.
Additional Info
Disclosure statements are available on the authors' profiles:
Methylphenidate Versus Placebo for Treating Fatigue in Patients With Advanced Cancer: Randomized, Double-Blind, Multicenter, Placebo-Controlled Trial
J. Clin. Oncol 2024 May 17;[EPub Ahead of Print], PC Stone, O Minton, A Richardson, P Buckle, ZE Enayat, L Marston, N FreemantleFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
Fatigue is a common and sometimes debilitating symptom related to metastatic cancer, and it can also be a side effect of the therapies administered. Although exercise is known to improve fatigue, it is generally not feasible for patients with chronic illness. Anecdotally, some patients have experienced improvements with methylphenidate therapy; however, these benefits were not shown in this randomized trial. Further efforts should be made to develop strategies to help with this extremely common symptom.