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June 4, 2008 (Chicago) -- The narcolepsy drug Provigil may help to relieve the debilitating fatigue often experienced by cancer patients undergoing chemotherapy, new research suggests.
"A majority of cancer patients expect they will experience fatigue and unfortunately, they're right," says Gary Morrow, MD, director of the University of Rochester Cancer Center.
A recent survey showed that nearly nine in 10 people with cancer suffer from lethargy and low energy levels during chemotherapy treatment.
Provigil is a member of a class of drugs called eugeroic agents that are used to treat narcolepsy and other sleep-related disorders. "They are basically non-amphetamine-based stimulants that improve wakefulness without causing addiction," Morrow tells WebMD.
The new study, funded by the National Cancer Institute, involved 642 cancer patients who were undergoing chemotherapy for a variety of cancer types. About half were randomly assigned to take Provigil; the others got a placebo.
The patients were surveyed about fatigue, sleepiness, and depression at the time the trial started, when they were undergoing their second cycle of chemotherapy. They were surveyed again during the fourth cycle of chemotherapy.
Results showed that patients taking the drug who had the most severe fatigue at the beginning of the study demonstrated significant improvement, compared with those in the placebo group. Severe fatigue was defined as a rating of six or more on a 10-point scale, where 0 was no fatigue and 10 the worst possible fatigue imaginable.
Morrow says about 30% to 40% of cancer patients taking chemo report debilitating fatigue.
Patients with mild or moderate fatigue at the start of the study did not get the same relief from the drug.
The drug also had a significant benefit on sleepiness but had no effect on depression.
The findings were presented at the annual meeting of the American Society of Clinical Oncology.
"If the research is confirmed by other studies, Provigil may gain FDA approval for this use," Morrow says.
Nicholas Petrelli, MD, medical director of the Helen F. Graham Cancer Center in Wilmington, Del., says the findings are promising.
"There is a real need to find more agents that lessen fatigue and improve cancer patients' quality of life," he tells WebMD.