CHICAGO — The wakefulness-promoting drug modafinil (Provigil) reduced self-reported severe fatigue, according to a study of more than 600 cancer patients undergoing chemotherapy that was presented at the annual meeting of the American Society of Clinical Oncology.
Gary R. Morrow, Ph.D., of the University of Rochester (N.Y.) and his colleagues randomized 631 patients undergoing four cycles of chemotherapy to receive either 200 mg modafinil daily or placebo. Among those with severe fatigue at baseline, patients on modafinil had significantly greater reductions in fatigue, compared with those on placebo.
Participants were asked to rate their level of fatigue at baseline (during the second cycle of chemotherapy) and during the final cycle. They rated fatigue on a 10-point scale: mild (1-4), moderate (5-6), and severe (7-10). A total of 67 patients reported mild fatigue at baseline; 106 and 458 reported moderate and severe fatigue, respectively.
Among patients with mild and moderate fatigue, modafinil also reduced fatigue, compared with placebo, but the differences were not significant. This was not surprising, Dr. Morrow said during a press briefing. “With side effects, quite often the potency of the effect is somewhat dependent on where you began,” he said.
Modafinil—a nonamphetamine stimulant—is currently indicated for the treatment of excessive sleepiness resulting from obstructive sleep apnea, shift-work sleep disorder, and narcolepsy.
Last year, researchers also at the University of Rochester reported success with modafinil in treating “chemo brain,” a reduction in cognitive function that has been associated with chemotherapy.
There may be some overlap between chemo brain and fatigue, Dr. Morrow said in an interview. Problems with executive function are commonly described in chemo brain. Cancer-related fatigue appears to particularly affect tasks associated with executive function. Cancer patients complain of not being able to “get around” to doing things they know they should do.
Cephalon Inc. provided modafinil and placebo for the trial. Dr. Morrow reported that he has no relevant financial relationships.