Phase III Evaluation of Fluoxetine for Treatment of Hot Flashes

• DOI: 10.1200/jco.2002.20.6.1578
• Publication Date: 2017-02-24T08:46:10Z
• Authors: Charles L. Loprinzi; Jeff A. Sloan; Edith A. Perez; Susan K. Quella; Phillip J. Stella; James A. Mailliard; Michele Y. Halyard; Sandhya Pruthi; Paul J. Novotny; Teresa A. Rummans
• Keywords: Hot flash

PURPOSE: Hot flashes can be a prominent problem in women with history of breast cancer. Given concerns regarding the use hormonal therapies such patients, other nonhormonal means for treating hot are required. Based on anecdotal information efficacy fluoxetine and newer antidepressants flashes, present trial was developed. PATIENTS AND METHODS: This used double-blinded, randomized, two-period (4 weeks per period), cross-over methodology to study (20 mg/d) cancer or concern estrogen (because risk). Eligible patients had have reported that they averaged at least 14 week; could received tamoxifen raloxifene as long were stable dose. The major outcome measure bivariate construct representing flash frequency score, analyzed by classic sums differences analysis. RESULTS: Eighty-one randomized began protocol therapy. By end first treatment period, scores (frequency × average severity) decreased 50% arm versus 36% placebo arm. Cross-over analysis demonstrated significantly greater marked score improvement than (P = .02). results not adjusted potential confounding influences, including age use. well tolerated. CONCLUSION: dose resulted modest flashes.