Patient-controlled methylphenidate for the management of fatigue in patients with advanced cancer: A preliminary report

Purpose: To assess the effects of patient-controlled methylphenidate for cancer-related fatigue. Patients and Methods: In this prospective open study, 31 patients with advanced cancer and fatigue who scored greater than or equal to 4 on a scale of 0 to 10 received methylphenidate 5 mg by mouth every 2 hours as needed for 7 days (maximum, 20 mg/d). Multiple symptoms were assessed daily; the primary end point, fatigue, was measured using the 0 to 10 scale, and the Functional Assessment for Chronic Illness Therapy-Fatigue (FACIT-F) was performed at baseline, day 7, and day 28. Results: The following mean (+/- standard deviation) scores for 30 assessable patients improved significantly between baseline and day 7: fatigue (0 to 10 scale), 7.2 +/- 1.6 v 3.0 +/- 1.9 (P <.001); overall well-being (0 to 10 scale), 4.5 +/- 2.2 v 2.8 +/- 2.1 (P <.001); fatigue (FACIT-F) subscore, 17.5 +/- 11.3 v 34.7 +/- 10.0 (P <.001); functional well-being, 14.4 +/- 5.9 v 18.3 +/- 6.6 (P <.001); and physical well-being, 13.5 +/- 6.4 v 21.4 +/- 5.0 (P <.001). Anxiety, appetite, pain, nausea, depression, and drowsiness all improved significantly (P <.05). All patients took afternoon or evening doses, and 28 patients (93%) took three or more doses daily. All patients chose to continue taking methylphenidate after 7 days of treatment. No serious side effects were reported. Conclusion: These preliminary results suggest that patient-controlled methylphenidate administration rapidly improved fatigue and other symptoms. Randomized controlled trials are justified. (C) 2003 by American Society of Clinical Oncology.