A Phase II Randomized Study of Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients Receiving Adjuvant Hormonal Therapy
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).
Detailed 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.
Arms & interventions
- Drugsolifenacin
oral solifenacin 5.0 mg daily for 3 weeks
- DrugClonidine
oral clonidine 0.1 mg daily for 3 weeks
Outcome measures
Primary
Efficacy: hot flash composite and frequency scores (daily diary)
to evaluate changes in hot flash composite and frequency scores for women receiving 3 weeks of oral solifenacin compared to those receiving 3 weeks of oral clonidine
Time frame: from baseline to end of treatment (3 weeks)
Safety: number of clinician-rated adverse events
to evaluate changes in number of adverse events for women receiving 3 weeks of oral solifenacin compared to those receiving 3 weeks of oral clonidine
Time frame: from consent until end of study (approximately 9 weeks)
Secondary
daily functioning (Hot Flash-Related Daily Interference score)
Time frame: from baseline to end of treatment (3 weeks)
sleep (Insomnia Severity Index)
Time frame: from baseline to end of treatment (3 weeks)
quality of life (Illness Cognition Questionnaire, SF-12)
Time frame: from baseline to end of treatment (3 weeks)
Eligibility criteria
Study locations (1)
Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical Sciences
Little Rock, Arkansas, 722205