Methylphenidate for fatigue in ambulatory men with prostate cancer Journal Article


Authors: Roth, A. J.; Nelson, C.; Rosenfeld, B.; Scher, H.; Slovin, S.; Morris, M.; O'Shea, N.; Arauz, G.; Breitbart, W.
Article Title: Methylphenidate for fatigue in ambulatory men with prostate cancer
Abstract: 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. © 2010 American Cancer Society.
Keywords: adult; clinical article; controlled study; aged; middle aged; clinical trial; fatigue; placebo; advanced cancer; drug efficacy; drug withdrawal; side effect; quality of life; controlled clinical trial; randomized controlled trial; methylphenidate; patient monitoring; prostate cancer; prostatic neoplasms; disease severity; ambulatory care; blood pressure; drug dose titration; drug dose increase; trend study; double blind procedure; double-blind method; tachycardia; placebos; pulse rate; central nervous system stimulants; heart rate; symptom control
Journal Title: Cancer
Volume: 116
Issue: 21
ISSN: 0008-543X
Publisher: Wiley Blackwell  
Date Published: 2010-11-01
Start Page: 5102
End Page: 5110
Language: English
DOI: 10.1002/cncr.25424
PUBMED: 20665492
PROVIDER: scopus
PMCID: PMC3632439
DOI/URL:
Notes: --- - "Cited By (since 1996): 2" - "Export Date: 20 April 2011" - "CODEN: CANCA" - "Source: Scopus"
Altmetric Score
MSK Authors
  1. William S Breitbart
    343 Breitbart
  2. Susan Slovin
    184 Slovin
  3. Michael Morris
    277 Morris
  4. Andrew J Roth
    85 Roth
  5. Gabrielle Arauz
    7 Arauz
  6. Christian Nelson
    257 Nelson
  7. Howard Scher
    833 Scher