June 4, 2007 A drug described by some people as a "genius pill" for enhancing cognitive function provided relief to a small group of Rochester breast cancer survivors who were coping with a side effect known as "chemo-brain," according to a University of Rochester Medical Center study.
Sixty-eight women, who had completed treatment for breast cancer, participated in an eight-week clinical trial testing the effects of modafinil (Provigil). All women took the drug for the first four weeks. During the next month half of the women continued to receive the drug while the other half took an identical looking placebo pill. The women who took modafinil for all eight weeks reported major improvements in memory, concentration and learning.
"I am very enthusiastic about the potential we've demonstrated," said Sadhna Kohli, Ph.D., M.P.H., lead author of the study and a research assistant professor at the University of Rochester's James P. Wilmot Cancer Center. "This is a novel drug and after completing the trial, many of the women wanted to know how they could continue to get modafinil."
Kohli presents the research -- which is believed to be the first to examine the drug's use in breast cancer patients -- on June 3 at the American Society of Clinical Oncology meeting in Chicago. ASCO is honoring Kohli with a Merit Award.
Originally licensed to treat narcolepsy, modafinil promotes wakefulness and seems to boost brainpower without causing the jittery, restless feelings induced by amphetamines. Modafinil is part of a class of drugs called eugeroics, which stimulate the brain only when it is required. The effects of modafinil disappear in about 12 hours. For this reason, sleep-deprived college students, athletes, soldiers or others who want to gain an edge in a competitive environment sometimes seek out the drug, calling it a "genius pill."
The application for cancer care is unique and entirely appropriate, Kohli said. Although some in the scientific community doubt the existence of "chemo-brain," many cancer patients insist they are suffering from an impairment of brain function after chemotherapy and desire some form of relief. In a separate study last year, Kohli found that 82 percent of 595 cancer patients reported problems with memory and concentration. Importantly, the deficits can lead to job loss or social dysfunction.
Scientists have not yet discovered the precise cause of "chemo-brain." A separate research group at the University of Rochester is investigating the toxicity of cancer-killing drugs on healthy brain cells. In 2006 they showed that chemotherapy disrupts cell division in the hippocampus, the brain region essential for learning and memory.
Until now, cancer patients had few options. Some studies have tested Ritalin, which stimulates the central nervous system. But Ritalin has unwanted side effects like headaches, irritability and addiction, Kohli said. Since modafinil does not linger in the body, side effects are minimal, according to recent studies.
Initially, researchers looked at whether modafinil might help alleviate fatigue, another persistent side effect, given the drug's use in narcoleptic patients. Once researchers saw the drug's positive effect on fatigue, they conducted secondary analyses to assess whether modafinil could improve the breast cancer patients' memory and attention skills.
Results showed the women had a faster memory and could more accurately recognize words and pictures after four weeks on the drug. The ability to focus attention, however, did not change at first. But after taking modafinil for another four weeks, attention deficits improved and memory was even greater. Larger studies are still needed to confirm the results.
Cephalon Inc., the maker of modafinil, and the National Cancer Institute funded the research.
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