A Phase II Randomized Study of Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients Receiving Adjuvant Hormonal Therapy
University of Arkansas
Summary
Hot flashes present a considerable problem for many breast cancer patients; these symptoms may be intensified by hormonal therapies, such as aromatase inhibitors or tamoxifen. This study examines the value of solifenacin (a muscarinic acetylcholine receptor antagonist) in reducing hot flashes, compared with clonidine (a medication often used for treating hot flashes).
Description
There has been considerable interest in developing new treatment strategies for managing hot flashes among women with breast cancer, in view of the limitations associated with currently available treatments. This randomized study evaluates the safety and efficacy of 3 weeks of solifenacin compared to 3 weeks of clonidine, for women receiving adjuvant hormonal therapy (aromatase inhibitors or tamoxifen) for breast cancer.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Women with a history of invasive breast cancer or DCIS * Currently taking aromatase inhibitors or tamoxifen * Not receiving hormone replacement therapy for minimum of one month * Age 18 years or older * Self-reported hot flashes at least fourteen times per week * Self-reported hot flashes for at least one month * If receiving non-tricyclic antidepressants (venlafaxine, paroxetine, citalopram, sertraline, etc.) or gabapentin, no change in regimen in past 4 weeks. Exclusion Criteria: * Receiving any other treatment for hot flashes within the past month, including estroge…
Interventions
- Drugsolifenacin
oral solifenacin 5.0 mg daily for 3 weeks
- DrugClonidine
oral clonidine 0.1 mg daily for 3 weeks
Location
- Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical SciencesLittle Rock, Arkansas