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UR Study: Seizure Drug Cools Cancer-Related Hot Flashes

Friday, September 02, 2005

Kishan Pandya, M.D.

Women with breast cancer who suffer hot flashes as a result of their treatment have a new option: the drug gabapentin at 900 milligrams daily was shown to offer significant relief with few side effects, according to a University of Rochester Medical Center study published in this week’s Lancet.

The gabapentin research is the latest in a long series of Rochester studies into hot flash relief. In 2000 a university neurologist treating a menopausal woman for migraines first observed that the seizure medication seemed to cure her hot flashes. Since then, a double-blind, placebo-controlled clinical trial confirmed those results in women suffering from hot flashes due to menopause. The current study shows that gabapentin provides control of hot flashes in women with breast cancer who suffer hot flashes as a result of their cancer treatment.

For thousands of breast cancer patients, gabapentin could improve the quality of life for anyone undergoing systemic therapy such as Tamoxifen, which induces hot flashes as a side effect, according to Kishan J. Pandya, M.D., professor of Medicine and Oncology at the UR’s James P. Wilmot Cancer Center and principal investigator of the study.

A total of 420 women with breast cancer who were having two or more hot flashes a day participated in the clinical trial. They either received placebo pills, 300 milligrams of gabapentin daily, or 900 milligrams of gabapentin daily. (Gabapentin was approved by the Food and Drug Administration to treat epileptic seizures, but it is also used to treat migraines, restless leg syndrome and bipolar disorder).

The women recorded their hot flashes (total number of mild, moderate, severe and very severe) and 10 other symptoms during the fourth and eighth weeks of their treatment.  Analysis showed a 46 percent decrease in hot flash severity for the group taking 900 milligrams of gabapentin, while the decrease was 31 percent for the 300 milligrams group, and 15 percent for the placebo group. There were no differences noted with respect to other symptoms among these groups, suggesting that gabapentin was well tolerated.

“Gabapentin is effective in the control of hot flashes at the dose of 900 milligrams/day, but not at the dose of 300 milligrams/day, and should be considered for the treatment of hot flashes in women with breast cancer,” the study concluded.

The National Cancer Institute funded the research, and Pfizer provided the drug for the clinical trial, which was based in Rochester but involved 18 medical centers, from June 2001 to July 2003.

In 2004,   the university signed a licensing agreement with Pfizer to market a non-hormonal hot flash treatment.

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