Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients
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 (
| Condition(s) | Hot Flashes, Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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). |
| Who can participate | 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 estrogens, progestins, androgens, or gabapentin. * Current use of clonidine or solifenacin. (If patients have been off of these for one month, then they are eligible) * History of severe renal or moderate or se |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | University of Arkansas |
| Locations | Little Rock, Arkansas, United States |
| Start date | 2012-02 |
| NCT ID | NCT01530373 |
| Official listing | https://clinicaltrials.gov/study/NCT01530373 |