Methylphenidate in Treating Patients With Fatigue Caused by Cancer

OBJECTIVES: Primary * Test the efficacy of long-acting methylphenidate in patients with cancer-related fatigue as measured using an item of the Brief Fatigue Inventory. Secondary * Evaluate the tolerability and adverse events associated with this drug in these patients. * Study the effect of this drug on quality of life (QOL)-related variables (vitality, sleep quality, overall QOL, QOL domains, other fatigue measures, and perceived treatment efficacy) in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease stage (0, I, or II vs III or IV), level of fatigue at baseline (4-7 vs 8-10), concurrent biological therapy (yes vs no), concurrent chemotherapy (yes vs no), and concurrent radiotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral methylphenidate daily on days 1-28. * Arm II: Patients receive oral placebo daily on days 1-28. Patients in both arms complete questionnaires to assess their symptoms of fatigue, overall mood, quality of life, sleep quality, and adverse effects from treatment at baseline and once weekly for 4 weeks. Patients also complete a Symptom Experience Diary. McNeil Consumer \& Specialty Pharmaceuticals provided medication support for NCCTG N05C7. PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study.