Actively Recruiting
Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients
Led by University of Arkansas · Updated on 2026-03-05
110
Participants Needed
1
Research Sites
865 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with a history of invasive breast cancer or DCIS
- Currently taking aromatase inhibitors or tamoxifen
- Not receiving hormone replacement therapy for a 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.
You will not qualify if you...
- Receiving any other treatment for hot flashes within the past month, including estrogens, progestins, androgens, or gabapentin
- Current use of clonidine or solifenacin (patients off these for one month are eligible)
- History of severe renal or moderate/severe hepatic impairment
- Concurrent or planned chemotherapy or radiotherapy within next 3 months
- Currently receiving tricyclic antidepressants, monoamine oxidase inhibitors, barbiturates, or pimozide
- Currently using CYP3A4 inducers or potent CYP3A4 inhibitors
- Uncontrolled or poorly controlled narrow-angle glaucoma, urinary retention, or gastric retention
- Hypotension or uncontrolled hypertension (BP outside 100/60 to 160/95 range)
- Severe coronary insufficiency, conduction disturbances, recent myocardial infarction (within past 3 months), cerebrovascular disease, or syncope
- History of allergy or adverse reactions to clonidine or solifenacin
- ECOG status greater than 2 (in bed more than 50% of the day)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 722205
Actively Recruiting
Research Team
A
Allen C Sherman, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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