Methylphenidate and Exercise in Reducing Cancer-Related Fatigue in Patients With Prostate Cancer

PRIMARY OBJECTIVE: I. To determine if the combination of exercise (EX) plus methylphenidate (MP) is superior to exercise plus placebo in the treatment of cancer-related fatigue (CRF) in patients with prostate cancer scheduled to receive radiotherapy with androgen deprivation therapy for 12 weeks. SECONDARY OBJECTIVE: I. To determine the effects of combined exercise plus methylphenidate on quality-of-life, mood, physical, and cognitive measures. EXPLORATORY OBJECTIVES: I. To identify potential synergistic effects of exercise and methylphenidate in improvement of CRF. II. To explore changes in brain activity by electroencephalography (EEG) in responders (with 4 point or greater change in Functional Assessment of Chronic Illness Therapy-Fatigue \[FACIT-F\] scores) versus (vs) non-responders to the intervention. OUTLINE: Patients are randomized to 1 of 4 groups. GROUP I: Patients receive methylphenidate orally (PO) twice daily (BID) and undergo exercise program consisting of resistance training twice weekly (BIW) and walking 15- 40 minutes a day 4 days a week for 12 weeks. GROUP II: Patients receive a placebo PO BID and undergo exercise program consisting of resistance training BIW and walking 15-40 minutes a day for 4 days a week for 12 weeks. GROUP III: Patients receive methylphenidate PO BID and undergo stretching for 4 days a week for 12 weeks. GROUP IV: Patients receive a placebo PO BID and undergo stretching for 4 days a week for 12 weeks. After completion of study treatment, patients are followed up at 3 months.