Jean-Pierre, P., Morrow, G. R., Roscoe, J. A., Heckler, C., Mohile, S., Janelsins, M., . . . Hopkins, J. O. (2010). A phase 3 randomized, placebo-controlled, double-blind, clinical trial of the effect of modafinil on cancer-related fatigue among 631 patients receiving chemotherapy: a University of Rochester Cancer Center Community Clinical Oncology Program Research base study. Cancer, 116, 3513–3520.
To examine the effect of modafinil on patient-reported fatigue in patients with cancer who were undergoing chemotherapy.
Assessments were conducted at baseline after randomization and shortly after cycle two of therapy. Modafinil or placebo was started at 100 mg on day 10 or day five of study cycle two, then increased to a full dose of 200 mg after three days. This regimen then was continued until day seven of treatment cycle four, at which time all patients discontinued medication.
This multisite study was set in 23 geographical areas across the United States among University of Rochester Cancer Center Community Clinical Oncology Program (URCC CCOP) affiliates.
This was a randomized, placebo-controlled, double-blind trial.
ANCOVA for BFI fatigue score showed an interaction between treatment effects and baseline BFI score (p = 0.017). A significant difference existed between the study groups for those who had severe fatigue at baseline (BFI of 7 or greater), with average score in the modafinil group. No differences in fatigue were observed between the study groups for those who had mild or moderate baseline fatigue. Daytime sleepiness on ESS showed significant improvement in the modafinil group (p = 0.002). No significant differences existed in depression outcomes between the groups. In the modafinil group, 11% of patients experienced adverse events, and in the placebo group, 9% had adverse events. Only three adverse events were judged to be definitely associated with treatment with modafinil: allergic reaction, dyspnea, and headaches.
The findings supported the use of 200 mg of modafinil as an effective treatment for severe cancer-related fatigue in patients undergoing chemotherapy. Modfinil was not effective for patients with less severe fatigue.