title: Efficacy and safety of modafinil in the treatment of cancer-related fatigue.
abstract: OBJECTIVE
  To review the efficacy and safety of modafinil in the treatment of cancer-related fatigue (CRF). DATA SOUCES: Literature was accessed via MEDLINE (1950-week 3, November 2008), International Pharmaceutical Abstracts, and Google Scholar using the terms modafinil, cancer, and fatigue. Reference citations from articles identified were reviewed.
  
  
  METHODS
  All English-language publications identified were analyzed for significance. Studies relevant to the objective were used, including 2 prospective open-label studies, one randomized double-blind, dose-controlled trial with an open-label extension, and one Phase 3 randomized, placebo-controlled, double-blind trial.
  
  
  RESULTS
  Fatigue is a nearly universal adverse effect of cancer and its treatment that is unrelated to physical exertion, is not relieved by sleep or rest, and negatively affects quality of life. Modafinil is a central nervous system stimulant with minimal toxicity and a low propensity for abuse. Clinical data demonstrate that modafinil significantly reduces fatigue in patients who have received cancer treatment or are currently undergoing chemotherapy. Additional benefits include improvement in cognitive function, mood, general activity, walking ability, normal work ability, relations with other people, and enjoyment of life. Limitations of the available data include open-label design in 3 of the 4 studies; the absence of numerical results of fatigue assessments in the abstract of 1 trial, preventing the determination of clinical significance; and the full inclusion/exclusion criteria, which were not included in the published abstracts. These limitations leave readers without a clear picture of the study populations. Finally, different patient populations at different points in treatment with varying durations of therapy were used, which makes extrapolation of data to the general population challenging.
  
  
  CONCLUSIONS
  Further randomized placebo-controlled trials are necessary to amass evidence for the effective and safe use of modafinil for CRF; however, if traditional therapies have failed or are intolerable, modafinil can be considered a treatment option.
authors.affiliation: Massachusetts College of Pharmacy and Health Sciences, Worcester, Manchester, NH 03101, USA. maryann.cooper@mcphs.edu
authors.forename: Maryann R
authors.initials: MR
authors.lastname: Cooper
authors.forename: Heather M
authors.initials: HM
authors.lastname: Bird
authors.forename: Michael
authors.initials: M
authors.lastname: Steinberg