Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients
NCT ID: NCT01530373
Last Updated: 2025-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
110 participants
INTERVENTIONAL
2012-02-29
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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solifenacin
oral solifenacin 5.0 mg daily for 3 weeks
solifenacin
oral solifenacin 5.0 mg daily for 3 weeks
clonidine
oral clonidine 0.1 mg daily for 3 weeks
Clonidine
oral clonidine 0.1 mg daily for 3 weeks
Interventions
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solifenacin
oral solifenacin 5.0 mg daily for 3 weeks
Clonidine
oral clonidine 0.1 mg daily for 3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
FEMALE
No
Sponsors
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University of Arkansas
OTHER
Responsible Party
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Principal Investigators
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Allen C Sherman, PhD
Role: PRINCIPAL_INVESTIGATOR
Universitiy of Arkansas for Medical Sciences
Locations
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Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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132500
Identifier Type: -
Identifier Source: org_study_id
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