Oxybutynin vs Placebo for Hot Flashes in Women With or Without Breast Cancer: A Randomized, Double-Blind Clinical Trial (ACCRU SC-1603)
| Autor: | Eric G. Wolfe, Charles L. Loprinzi, Daniel Flora, Mark L Graham, Roberto A. Leon-Ferre, Stephanie S. Faubion, Kathryn J. Ruddy, Christopher S R Dakhil, Kendrith M. Rowland, Nguyet A. Le-Lindqwister, Paul J. Novotny, Thomas J. Smith |
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| Rok vydání: | 2019 |
| Předmět: |
Cancer Research
medicine.medical_specialty 030219 obstetrics & reproductive medicine Aromatase inhibitor medicine.drug_class business.industry Urology medicine.disease Placebo Article Discontinuation Clinical trial 03 medical and health sciences 0302 clinical medicine Breast cancer Oncology 030220 oncology & carcinogenesis medicine Clinical endpoint Oxybutynin Adverse effect business medicine.drug |
| Zdroj: | JNCI Cancer Spectrum |
| ISSN: | 2515-5091 |
| Popis: | Background Hot flashes (HFs) negatively affect quality of life among perimenopausal and postmenopausal women. This study investigated the efficacy of oxybutynin vs placebo in decreasing HFs. Methods In this randomized, multicenter, double-blind study, women with and without breast cancer with 28 or more HFs per week, lasting longer than 30 days, who were not candidates for estrogen-based therapy, were assigned to oral oxybutynin (2.5 mg twice a day or 5 mg twice a day) or placebo for 6 weeks. The primary endpoint was the intrapatient change from baseline in weekly HF score between each oxybutynin dose and placebo using a repeated-measures mixed model. Secondary endpoints included changes in weekly HF frequency, HF-related daily interference scale questionnaires, and self-reported symptoms. Results We enrolled 150 women. Baseline characteristics were well balanced. Mean (SD) age was 57 (8.2) years. Two-thirds (65%) were taking tamoxifen or an aromatase inhibitor. Patients on both oxybutynin doses reported greater reductions in the weekly HF score (5 mg twice a day: −16.9 [SD 15.6], 2.5 mg twice a day: −10.6 [SD 7.7]), placebo −5.7 (SD 10.2); P Conclusion Oxybutynin is an effective and relatively well-tolerated treatment option for women with HFs. |
| Databáze: | OpenAIRE |
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