Researchers from the University of Rochester have reported that the eugeroic drug Provigil® (modafinil) is useful for the treatment of cancer-related fatigue. The details of this study were presented at the 2008 meeting of the American Society of Clinical Oncology in Chicago, May 30-June 2.¹

Eugeroic agents are a relatively new class of drugs that reduce the need for sleep. It is claimed that these agents enhance an alert and wakeful state without the side effects of earlier stimulants. These agents are approved by the FDA for the treatment of sleep disorders such as narcolepsy, sleep apnea, and other sleep-related problems. Provigil has also been used to treat attention deficit hyperactive disorder. These agents have also been utilized in the military and by airline flight crews to promote alertness. Provigil is eliminated from the body in 12 hours and is reported to be non-addicting.

The current randomized trial included 642 patients with cancer-related fatigue who were undergoing chemotherapy for a variety of cancers. Patients were randomized to receive Provigil (n=320) or placebo (n=322) and were evaluated for fatigue, sleepiness, and depression at two different time points. These authors reported that patients with severe baseline fatigue had significant improvement on Provigil compared with placebo (p=0.017). However, patients with mild to moderate fatigue did not show improvement. All patients in the study appeared to have less “sleepiness” than in the control group (p=0.002). Provigil had no effect on depression. These authors concluded that Provigil could be of benefit in treating severe cancer-related fatigue.

Comments: These are interesting findings that will probably be pursued in further studies to better define the role of Provigil in treating cancer-related fatigue and other side effects of cancer and treatments for cancer.

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Reference:

¹ Morrow GR, Jean-Pierre P, Roscoe JA, et al. A phase III randomized, placebo-controlled, double-blind trial of a eugeroic agent in 642 cancer patients reporting fatigue during chemotherapy: a URCC CCOP Study. Journal of Clinical Oncology. 2008;26:abstract 9512