Phase II Study of Solifenacin Versus Clonidine to Reduce Hot Flashes in Women With Breast Cancer Receiving Hormonal Therapy

What this Trial Is About

Researchers are evaluating solifenacin, a muscarinic acetylcholine receptor antagonist, compared to clonidine, a medication commonly used to treat hot flashes, in women with breast cancer who are experiencing hot flashes. The study focuses on women receiving adjuvant hormonal therapy, such as aromatase inhibitors or tamoxifen, who report frequent hot flashes. The goal is to assess the safety and effectiveness of these treatments in reducing hot flashes over a short period. Participants are randomly assigned to one of two groups one group receives oral solifenacin 5.0 mg daily for three weeks, and the other receives oral clonidine 0.1 mg daily for the same duration. This phase II study involves a triple-blind design to compare these two treatments directly. The treatment period lasts three weeks, during which the effects on hot flashes are closely monitored. Throughout the study, participants keep daily diaries to track hot flash frequency and severity. Researchers also assess safety by recording adverse events from consent through approximately nine weeks. Secondary measures include evaluations of daily functioning, sleep quality, and overall quality of life during the treatment period. This comprehensive monitoring helps determine how these medications impact symptoms and well-being in women undergoing hormonal therapy for breast cancer.

Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients