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

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 safely of a 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 it 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 relayed 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 to should be considered. J Pain Symptom Manage 2009;38:650-662. (C) 2009 U.S. Cancer Pain. Relief Committee. Published by Elsevier Inc. All rights reserved.