A Pilot Study Evaluating the Safety and Efficacy of Modafinil for Cancer-Related Fatigue

Abstract Background: Fatigue is a common symptom that lowers the quality of life of patients with cancer, affecting between 60% and 90% of patients. Relatively few options are available for the treatment of this debilitating condition. Modafinil, a psychostimulant developed for the treatment of narcolepsy, has been used to treat fatigue in other diseases such as multiple sclerosis, but little data support its use in cancer patients. Objective and design: The primary objective of this open-label pilot study was to evaluate the safety, and efficacy of modafinil in improving cancer-related fatigue (CRF) as measured by the Brief Fatigue Inventory (BFI). The effect of this agent on depression, quality of life, functional status, and cognitive function was also assessed. Modafinil was self-administered at a dose of 100 mg/d during weeks 1–2, and 200 mg during weeks 3–4. Assessments were performed at baseline, 2, and 4 weeks. Results: BFI score was improved in 46% of patients at 2 weeks and 75% at 4 weeks (p = 0...