Cooper, M. R., Bird, H. M., & Steinberg, M. (2009). Efficacy and safety of modafinil in the treatment of cancer-related fatigue. Annals of Pharmacotherapy, 43, 721–725.

To review the efficacy and safety of modafinil for the treatment of cancer-related fatigue (CRF).

Databases searched were MEDLINE, International Pharmaceutical Abstracts, and Google Scholar (1950–November 2008).

Search keywords were modafinil, cancer, and fatigue.

Studies were included in the review if they were written in English.

No exclusion criteria were specified.

Articles were identified using the keywords, and publications were analyzed for significance. References from the identified articles were also reviewed for pertinence.

• Four studies were reviewed in detail, comprising a total of 805 patients.
• Two studies reported patients with breast cancer, one reported patients with cerebral tumors, and one reported that the diagnoses were unknown.

• One open-label trial demonstrated the effectiveness of 200 mg of modafinil daily, given for one month, in reducing fatigue and improving patient-reported global effectiveness.  Fifty-one percent of participants reported improvement in sleep and less daytime drowsiness.
• One open-label trial in women with breast cancer reported that 90% of participants reported improvement in fatigue with 200 mg of modafinil daily for one month.
• One randomized, dose-controlled trial was conducted in patients with cerebral tumors who had neurobehavioral dysfunction and/or fatigue posttreatment. Improvements in fatigue scores were seen eight weeks after baseline. Adverse effects included headache, insomnia, dizziness, dry mouth, depressed consciousness, and nausea.  The authors concluded that modafinil was effective in improving fatigue, with a low incidence of adverse reactions.
• One phase III, randomized, placebo-controlled, double-blind trial was conducted in 642 patients with cancer who reported fatigue while receiving chemotherapy. Those receiving modafinil had a significant decrease in fatigue levels compared with patients receiving placebo.

This review discussed the strengths and weaknesses of four relevant studies. The authors concluded that the preliminary findings demonstrated the benefits of modafinil use with minimal toxicity and that modafinil can be considered a treatment option for patients with CRF. Additional long-term placebo-controlled trials are needed in this area.

• Some of the evidence reviewed in this study was taken only from abstracts.
• The literature evaluated and selected were not clearly outlined.
•  No inclusion and exclusion criteria were specified other than language.