A phase II randomized, placebo-controlled, double blind trial of a eugeroic agent in 642 cancer patients reporting fatigue during chemotherapy: A URCC CCOP study

Carolyn Vachani, RN, MSN, AOCN
The Abramson Cancer Center of the University of Pennsylvania
Last Modified: June 23, 2008

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A phase II randomized, placebo-controlled, double blind trial of a eugeroic agent in 642 cancer patients reporting fatigue during chemotherapy: A URCC CCOP study

Cancer-related fatigue (CRF) is one of the most common side effects of cancer and its treatment, and has been shown to affect nearly 70-100% of cancer patients in previous studies. This study evaluated the effect of modafanil, an agent used in the treatment of narcolepsy, on cancer related fatigue.

642 participants were randomly assigned to receive modafanil or placebo from the second cycle of chemotherapy through the fourth. The drug had a positive effect on fatigue, but only for those patients who rated their fatigue as severe. The group receiving modafanil also reported less sleepiness.

Unfortunately, the researchers did not report on the side effects of the drug, so it is difficult to know how well tolerated it was among the participants. The scale used to measure fatigue may not have been the best choice. More data may have been gained from evaluating functional status or time spent sleeping during the day. Although some questions remained unanswered, this data may help to further study this or other drugs in the treatment of fatigue.


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