Phase III, randomized, double-blind, placebo-controlled study of long-acting
methylphenidate for cancer-related fatigue: North Central Cancer Treatment Group
NCCTG-N05C7 trial.
Author(s): Moraska AR, Sood A, Dakhil SR, Sloan JA, Barton D, Atherton PJ, Suh JJ, Griffin
PC, Johnson DB, Ali A, Silberstein PT, Duane SF, Loprinzi CL.
Affiliation(s): Mayo Clinic, Rochester, MN 55905, USA.
Publication date & source: 2010, J Clin Oncol. , 28(23):3673-9
PURPOSE: Fatigue is one of the most common symptoms experienced by patients with
cancer. This trial was developed to evaluate the efficacy of long-acting
methylphenidate for improving cancer-related fatigue and to assess its
toxicities.
PATIENTS AND METHODS: Adults with cancer were randomly assigned in a
double-blinded manner to receive methylphenidate (target dose, 54 mg/d) or
placebo for 4 weeks. The Brief Fatigue Inventory was the primary outcome measure,
while secondary outcome measures included a Symptom Experience Diary (SED), the
Short Form-36 (SF-36) Vitality Subscale, a linear analog self-assessment, the
Pittsburgh Sleep Quality Index, and the Subject Global Impression of Change.
RESULTS: In total, 148 patients were enrolled. Using an area under the serum
concentration-time curve analysis, there was no evidence that methylphenidate, as
compared with placebo, improved the primary end point of cancer-related fatigue
in this patient population (P = .35). Comparisons of secondary end points,
including clinically significant changes in quality-of-life variables and
cancer-related fatigue change from baseline, were similarly negative. However, a
subset analysis suggested that patients with more severe fatigue and/or with more
advanced disease did have some fatigue improvement with methylphenidate (eg, in
patients with stage III or IV disease, the mean improvement in usual fatigue was
19.7 with methylphenidate v 2.1 with placebo; P = .02). There was a significant
difference in self-reported toxicities (SED), with increased levels of
nervousness and appetite loss in the methylphenidate arm.
CONCLUSION: This clinical trial was unable to support the primary prestudy
hypothesis that the chosen long-acting methylphenidate product would decrease
cancer-related fatigue.
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