Patient-controlled methylphenidate for cancer fatigue: a double-blind, randomized, placebo-controlled trial.
OBJECTIVE
To evaluate the effectiveness of patient-controlled methylphenidate as compared with placebo in cancer patients with fatigue, as measured by the Functional Assessment for Chronic Illness Therapy-Fatigue (FACIT-F).


METHODS
Patients with a fatigue score of at least 4 on a scale of 0 to 10 (0 = no fatigue, 10 = worst possible fatigue) and hemoglobin level of at least 10 g/dL were included. Patients were randomly assigned to receive 5 mg methylphenidate or placebo every 2 hours as needed (maximum of four capsules a day), for 7 days. Patients completed a daily diary including study drug record and fatigue intensity. A research nurse telephoned patients daily to assess toxicity and fatigue level. All patients were offered open-label methylphenidate for 4 weeks. FACIT-F and the Edmonton Symptom Assessment System (ESAS) were assessed at baseline, and days 8, 15, and 36. The FACIT-F fatigue subscore on day 8 was considered the primary end point.


RESULTS
Of 112 patients randomly assigned, 52 patients in the methylphenidate and 53 in the placebo group were assessable for analysis. Fatigue intensity improved significantly on day 8 in both the methylphenidate and placebo groups. However, there was no significant difference in fatigue improvement by FACIT-F (P = .31) or ESAS (P = .14) between groups. In open-label phase, fatigue intensity maintained low as compared with baseline. No significant toxicities were observed.


CONCLUSIONS
Both methylphenidate and placebo resulted in significant symptom improvement. Methylphenidate was not significantly superior to placebo after 1 week of treatment. Longer study duration is justified. The role of daily telephone calls from a research nurse should be explored as a palliative care intervention.
Bruera
Eduardo
E
Department of Palliative Care and Rehabilitation Medicine, Unit 0008, The University of Texas M.D. Anderson Cancer Center, Houston, TX 77030-4009, USA. ebruera@mail.mdanderson.org
Valero
Vicente
V
Driver
Larry
L
Shen
Loren
L
Willey
Jie
J
Zhang
Tao
T
Palmer
J Lynn
JL
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000697:Central Nervous System Stimulants / Q000627:therapeutic use*; D004311:Double-Blind Method; D005221:Fatigue / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000627:therapeutic use*; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications* / Q000188:drug therapy; D012646:Self Administration
D000697:Central Nervous System Stimulants; D008774:Methylphenidate