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Solifenacin vs. Clonidine for Hot Flashes in Breast Cancer Patients

This study is comparing two medications, solifenacin and clonidine, to see how well they reduce hot flashes in women who have had breast cancer. Hot flashes can be a big problem, especially for those taking hormone therapies like aromatase inhibitors or tamoxifen. You might be able to join if you are a woman aged 18 or older with a history of invasive breast cancer or DCIS, are currently taking aromatase inhibitors or tamoxifen, and experience at least 14 hot flashes per week. The study will measure how much your hot flashes improve and also track any side effects. The current status of this study is unclear, and it plans to enroll about 110 participants.

Study design
This is an interventional study comparing two different medications. It plans to enroll about 110 women.
What's involved
You would take either oral solifenacin 5.0 mg daily or oral clonidine 0.1 mg daily for 3 weeks.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured from consent until the end of the study, which is approximately 9 weeks.

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NCT01530373

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

Recruiting
PHASE2Ages 18+InterventionalSupportive care
University of Arkansas
~110 participants
Updated 2026-03-05 on ClinicalTrials.gov
What's tested:solifenacinClonidine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy: hot flash composite and frequency scores (daily diary)
Measured over from baseline to end of treatment (3 weeks)
+1 more outcome measured

Conditions

Hot Flashes
Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Arkansas1

Study leadership

  • Allen C Sherman, PhD · PRINCIPAL_INVESTIGATOR · Universitiy of Arkansas for Medical Sciences

Who to contact

Allen C Sherman, PhD
[email protected]
501-686-8700
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 severe hepatic impairment, as indicated by physical exam and medical record
Concurrent or planned chemotherapy or radiotherapy (within next 3 months)
Currently receiving tricyclic antidepressants, monoamine oxidase inhibitors, barbiturates, pimozide.
Currently using CYP3A4 inducers (i.e., aminoglutethimide, carbamazepine, dexamethasone, efavirenz, ethosuximide, griseofulvin, modafinil, nafcillin, nevirapine, oxcarbazepine, phenobarbital, phenylbutazone, phenytoin, primidone, rifabutin, rifampin, rifapentine, St. John's Wort, sulfadimidine, sulfinpyrazone, troglitazone) or potent CYP3A4 inhibitors (i.e., chloramphenicol, clarithromycin, erythromycin, imatinib mesylate, indinavir sulfate, itraconazole, ketoconazole, nefazoldone, nelfinavir mesylate, ritonavir, telithromycin, troleandomycin).
Uncontrolled or poorly controlled narrow-angle glaucoma, urinary retention, gastric retention (evaluated from history \& physical exam and medical record)
Hypotension or uncontrolled hypertension (160/95 \> BP \< 100/60)
Severe coronary insufficiency, conduction disturbances, recent myocardial infarction (within past 3 months), cerebrovascular disease, syncope (evaluated from history \& physical and medical record)
History of allergy or adverse reactions to clonidine or solifenacin
ECOG status \> 2 (in bed more than 50% of day)

What this trial measures

  • Efficacy: hot flash composite and frequency scores (daily diary)from baseline to end of treatment (3 weeks)

    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

  • Safety: number of clinician-rated adverse eventsfrom consent until end of study (approximately 9 weeks)

    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