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.

Background: Cancer-related fatigue is a debilitating symptom affecting psychosocial functioning and quality of life in 70% to 100% of cancer patients during and after treatment. The authors examined the effect of 200 mg of modafinil daily on the severity of cancer-related fatigue.

Methods: The authors conducted a multicenter, randomized, double-blind, placebo-controlled, phase 3, clinical trial to examine the effect of modafinil on patient-reported fatigue in cancer patients undergoing chemotherapy.