A phase II study of methylphenidate for the treatment of fatigue

Background: Cancer-related fatigue (CRF) is one of the most distressing symptoms patients experience and is seen well after the completion of treatment. Methylphenidate (Ritalin) use includes the treatment of opiate-induced somnolence, depression, and reduced cognition. This phase II study was performed to evaluate the effects of methylphenidate on CRF. Patients and methods: The criteria for the eligibility of patients included the following: a history of breast cancer, absence of disease for greater than 6 months but less than 5 years, a hemoglobin level of > 12 g%, less than moderate depression on the Brief Zung Self-administered Depression Scale, and a score of >= 4 on the Brief Fatigue Inventory (BFI). Patients received methylphenidate, 5 mg, orally, twice daily, for 6 weeks, with a dose escalation on week 2 if the BFI score remained >= 4 and no significant toxicities were reported. A response was defined as a decrease in the BFI score of at least two points on weeks 4 and 6 as compared to baseline. Results: Between May 2001 and May 2003, 37 patients were entered and treated. On weeks 4 and 6, 20 of 37 (54%) responded with a decreased BFI score greater than two points, averaging a decrease of 3.5. Although six patients (19%) withdrew due to adverse events, these were reported as grade 1. Conclusion: This study suggests that women with breast cancer who are suffering from moderate to severe fatigue may benefit from methylphenidate.