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Modafinil Appears to Improve Fatigue, Mental Well-Being of Patients With Brain Tumors: Presented at ASCO

By Ed Susman

ATLANTA, G.A. -- June 6, 2006 -- Patients battling primary brain tumors appear to improve cognition and decrease depression and fatigue by taking the drug modafinil, a medication used in some sleep disorders, researchers said here at the American Society of Clinical Oncology 2006 Annual Meeting (ASCO).

"Statistically significant and clinically meaningful outcomes were found at 8, 10, and 12 weeks postmodafinil initiation in this therapeutic trial," said Thomas Kaleita, PhD, assistant professor of psychiatry, University of California, Los Angeles, California, in an oral presentation on June 5^th.

The study enrolled 30 patients with a variety of brain tumors, including 10 patients with anaplastic gliomas and 8 with glioblastomas. The average age of the patients was 45.3 years and 19 were men.

Patients were evaluated using several psychological tests, including tests of cognition, as well as self-reports of fatigue and depression. Patients were started on 50 mg of modafinil and titrated up to 600 mg a day.

Statistically significant improvements were seen across the board -- on the cognitive trail-making tests, the standard Hamilton Depression Scale, and on fatigue tests. Cognitive abilities increased by 21%, mood improved by 35%, and fatigue decreased by 47%, Dr. Kaleita said. All changes from baseline were highly statistically significant.

At baseline, the patients scored a mean of 17.8 on the Hamilton scale, a level that showed true depression, Dr. Kaleita said. But after 8 weeks of treatment on modafinil, the average score decreased by 43% to 7.6 points, a finding that reached statistical significance at the P <.0001 level. The improvement in the depression scores was sustained through 12 weeks in this study, although the scores increased 2.1 points in that time. Even so, the overall 5.5 decline in scores was still significant at the P =.004 level.

"This study shows there is hope for people with brain cancer, and that there are interventions that can improve quality of life," Dr. Kaleita said.

"These changes aren't just statistically significant, they are clinically meaningful," said Jeff Sloan, PhD, researcher in oncology, Mayo Clinic Comprehensive Cancer Center, Rochester, Minnesota. "They are huge."

Dr. Sloan said the studies show that cancer is not just about treatment, but that there is a complex system involved, in brain cancer especially, and that fatigue may play a major role in a patient's well-being.


[Presentation title: Pilot Study of Modafinil for Treatment of Neurobehavioral Dysfunction and Fatigue in Adult Patients With Brain Tumors. Abstract 1503]

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