Methylphenidate for fatigue in ambulatory men with prostate cancer

Cancer. 2010 Nov 1;116(21):5102-10. doi: 10.1002/cncr.25424.


Background: Fatigue is a highly prevalent and clinically significant symptom of advanced prostate cancer. To date, however, there are no published controlled trials of interventions for fatigue in men with prostate cancer.

Methods: This 6-week, randomized, double-blind, placebo-controlled design evaluated the efficacy of methylphenidate to treat fatigue in prostate cancer patients. Inclusion criteria included men with advanced prostate cancer and the presence of moderate to severe fatigue. Patients with major depression, hypothyroidism, uncontrolled hypertension, arrhythmia, or anemia were excluded. Fatigue levels, blood pressure, pulse, and other safety concerns were monitored regularly.

Results: Thirty-two subjects were randomized to methylphenidate (n=16) or placebo (n=16). Brief Fatigue Inventory total scores significantly decreased for both groups; however, the methylphenidate group, as compared with placebo, reported greater decrease on Brief Fatigue Inventory severity scores (P=.03) and a trend toward greater decrease on Brief Fatigue Inventory total scores (P=.07). A significantly greater number of subjects in the methylphenidate group versus the placebo group demonstrated clinically significant improvement in fatigue on total Brief Fatigue Inventory scores (7 of 10 vs 3 of 13) and Brief Fatigue Inventory severity scores (8 of 10 vs 3 of 13). Importantly, 6 subjects in the methylphenidate group discontinued because of increased blood pressure or tachycardia. There were no serious adverse events.

Conclusions: Methylphenidate is effective in treating fatigue in men with prostate cancer; however, oncologists need to monitor for possible pulse and blood pressure elevations.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Ambulatory Care
  • Blood Pressure / drug effects
  • Central Nervous System Stimulants / therapeutic use*
  • Double-Blind Method
  • Fatigue / complications*
  • Fatigue / drug therapy*
  • Heart Rate / drug effects
  • Humans
  • Male
  • Methylphenidate / adverse effects
  • Methylphenidate / therapeutic use*
  • Middle Aged
  • Placebos
  • Prostatic Neoplasms / complications*
  • Prostatic Neoplasms / drug therapy


  • Central Nervous System Stimulants
  • Placebos
  • Methylphenidate