Original Article
Efficacy of Dexmethylphenidate for the Treatment of Fatigue After Cancer Chemotherapy: A Randomized Clinical Trial

https://doi.org/10.1016/j.jpainsymman.2009.03.011Get rights and content
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Abstract

Cancer and its treatment can induce subjective and objective evidence of diminished functional capacity encompassing physical fatigue and cognitive impairment. Dexmethylphenidate (d-MPH; the d-isomer of methylphenidate) was evaluated for treatment of chemotherapy-related fatigue and cognitive impairment. A randomized, double-blind, placebo-controlled, parallel-group study evaluated the potential therapeutic effect and safety of d-MPH in the treatment of patients with chemotherapy-related fatigue. Change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue Subscale (FACIT-F) total score at Week 8 was the primary outcome measure. One hundred fifty-four patients (predominantly with breast and ovarian cancers) were randomized and treated. Compared with placebo, d-MPH-treated subjects demonstrated a significant improvement in fatigue symptoms at Week 8 in the FACIT-F (P = 0.02) and the Clinical Global Impression-Severity scores (P = 0.02), without clinically relevant changes in hemoglobin levels. Cognitive function was not significantly improved. There was a higher rate of study drug-related adverse events (AEs) (48 of 76 [63%] vs. 22 of 78 [28%]) and a higher discontinuation rate because of AEs (8 of 76 [11%] vs. 1 of 78 [1.3%]) in d-MPH-treated subjects compared with placebo-treated subjects. The most commonly reported AEs independent of study drug relationship in d-MPH-treated subjects were headache, nausea, and dry mouth, and in placebo-treated subjects were headache, diarrhea, and insomnia. d-MPH produced significant improvement in fatigue in subjects previously treated with cytotoxic chemotherapy. Further studies with d-MPH or other agents to explore treatment response in chemotherapy-associated fatigue should be considered.

Key Words

Dexmethylphenidate
chemobrain
chemotherapy-related fatigue

Cited by (0)

This study was supported by investigator grants to E. E. L. and S. F. from the sponsor, Celgene Corporation. Novartis Corporation, East Hanover, NJ, supplied the study drug.

Presented as an abstract (No. 8000) at the 2005 American Society of Clinical Oncology Annual Meeting, and as a poster presentation (No. 5026) at the 2005 San Antonio Breast Cancer Symposium Annual Meeting.