Loprinzi, C.L., Sloan, J.A., Perez, E.A., Quella, S.K., Stella, P.J., Mailliard, J.A., … Rummans, T.A. (2002). Phase III evaluation of fluoxetine for treatment of hot flashes. Journal of Clinical Oncology, 20, 1578–1583.doi:10.1200/JCO.20.6.1578
The study sought to assess the efficacy of fluoxetine for treatment of hot flashes in women with a history of breast cancer or a concern regarding the use of estrogen because of a breast cancer risk.
Patients received four weeks of fluoxetine (20 mg/day orally) versus an identical-appearing placebo. For the next four weeks, patients were crossed over to the alternative arm.
The study enrolled 81 women with a history of breast cancer or a perceived increased risk of breast cancer. Sevent-two patients completed the study. Their mean age was older than 50 years.
This was a placebo-controlled, double-blind, cross-over clinical trial.
At the end of the first treatment period (four weeks), hot flash scores (frequency x average severity) decreased 50% inthe fluoxetine arm versus 36% in the placebo arm. Cross-over analysis showed a significantly greater improvement in hot flash scores with fluoxetine than placebo (p = .02). More than half (54%) of the patients reported depressive symptoms of at least mild severity at baseline compared with only 30% of patients after the first treatment period and 21% after the second treatment period. After five weeks of treatment, QOL did not differ between groups. After cross-over, QOL showed a relative improvement trend for fluoxetine compared to placebo.
Age and tamoxifen use were not adjusted for as potential confounding factors.