Hovey, E., de Souza, P., Marx, G., Parente, P., Rapke, T., Hill, A., . . . Lloyd, A. (2014). Phase III, randomized, double-blind, placebo-controlled study of modafinil for fatigue in patients treated with docetaxel-based chemotherapy. Supportive Care in Cancer, 22, 1233-1242.
To determine whether modafinil could reduce fatigue related to docetaxel chemotherapy
Patients with metastatic breast or prostate cancer receiving docetaxel chemotherapy and experiencing significant fatigue were randomized to receive modafinil or placebo for 15 days beginning with their third cycle of treatment and repeated for 2–4 subsequent chemotherapy cycles.
The goal was a 10% or greater relative difference between the two treatment groups.
The primary endpoint of reduced fatigue during docetaxel chemotherapy was not statistically different between the two treatment arms.
Features a trend in docetaxel-related fatigue. Effectiveness was not established for the broader cancer-related fatigue treatment.