Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients
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ClinicalTrials.gov Identifier: NCT01530373 |
Recruitment Status :
Active, not recruiting
First Posted : February 9, 2012
Last Update Posted : March 31, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hot Flashes Breast Cancer | Drug: solifenacin Drug: Clonidine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Supportive Care |
Official Title: | A Phase II Randomized Study of Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients Receiving Adjuvant Hormonal Therapy |
Study Start Date : | February 2012 |
Estimated Primary Completion Date : | July 2021 |
Estimated Study Completion Date : | September 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: solifenacin
oral solifenacin 5.0 mg daily for 3 weeks
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Drug: solifenacin
oral solifenacin 5.0 mg daily for 3 weeks
Other Name: Vesicare |
Active Comparator: clonidine
oral clonidine 0.1 mg daily for 3 weeks
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Drug: Clonidine
oral clonidine 0.1 mg daily for 3 weeks
Other Name: Catapres, Dixarit |
- hot flash composite and frequency scores (daily diary) [ Time Frame: 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
- number of clinician-rated adverse events [ Time Frame: from baseline to end of treatment (3 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
- daily functioning (Hot Flash-Related Daily Interference score) [ Time Frame: from baseline to end of treatment (3 weeks) ]to evaluate changes in daily functioning (Hot Flash-Related Daily Interference Score) for women receiving 3 weeks of oral solifenacin compared to those receiving 3 weeks of oral clonidine
- sleep (Insomnia Severity Index) [ Time Frame: from baseline to end of treatment (3 weeks) ]To evaluate changes in sleep
- quality of life (Illness Cognition Questionnaire, SF-12) [ Time Frame: from baseline to end of treatment (3 weeks) ]to evaluate changes in health-related quality of life. (Additional analyses will be observational, exploring associations between quality of life and meaning-making.)

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Ages Eligible for Study: | 18 Years to 95 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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 greater than fourteen times per week
- Self-reported hot flashes for at least one month
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 monoamine oxidase inhibitors, L-dopa, piribedil, barbiturates, moxifloxacin, pimozide, or antihypertensive treatment
- 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., clarithromycin, chloramphenicol, erythromycin, imatinib mesylate, Indinavir sulfate, itraconazole, ketoconazole, nefazodone, nelfinavir mesylate, ritonavir, telithromycin, troleandomycin).
- Uncontrolled or poorly controlled closed-angle glaucoma, urinary retention, gastric retention (evaluated from history & physical exam and medical record)
- Hypotension (systolic BP < 80)
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530373
United States, Arkansas | |
Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical Sciences | |
Little Rock, Arkansas, United States, 722205 |
Principal Investigator: | Allen C Sherman, PhD | Universitiy of Arkansas for Medical Sciences |
Responsible Party: | University of Arkansas |
ClinicalTrials.gov Identifier: | NCT01530373 |
Other Study ID Numbers: |
132500 |
First Posted: | February 9, 2012 Key Record Dates |
Last Update Posted: | March 31, 2020 |
Last Verified: | March 2020 |
hot flashes breast cancer aromatase inhibitors |
solifenacin clonidine quality of life |
Breast Neoplasms Hot Flashes Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Clonidine Solifenacin Succinate Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antihypertensive Agents |
Sympatholytics Autonomic Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Urological Agents |