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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01530373
Recruitment Status : Active, not recruiting
First Posted : February 9, 2012
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Hot Flashes Breast Cancer Drug: solifenacin Drug: Clonidine Phase 2

Detailed Description:
There has been considerable interest in developing new treatment strategies for managing hot flashes among women with breast cancer, in view of the limitations associated with currently available treatments. This randomized study evaluates the safety and efficacy of 3 weeks of solifenacin compared to 3 weeks of clonidine, for women receiving adjuvant hormonal therapy (aromatase inhibitors or tamoxifen) for breast cancer.
Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: solifenacin
oral solifenacin 5.0 mg daily for 3 weeks
 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
 Drug: Clonidine
oral clonidine 0.1 mg daily for 3 weeks
Other Name: Catapres, Dixarit


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. sleep (Insomnia Severity Index) [ Time Frame: from baseline to end of treatment (3 weeks) ]
    To evaluate changes in sleep

  3. 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.)


Eligibility Criteria
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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
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Arkansas
Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 722205
Sponsors and Collaborators
University of Arkansas
Investigators
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Principal Investigator: Allen C Sherman, PhD Universitiy of Arkansas for Medical Sciences
More Information
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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
Keywords provided by University of Arkansas:
hot flashes
breast cancer
aromatase inhibitors
 solifenacin
clonidine
quality of life
Additional relevant MeSH terms:
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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