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

May 12, 2023 updated by: University of Arkansas

A Phase II Randomized Study of Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients Receiving Adjuvant Hormonal Therapy

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 722205
        • Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Catapres, Dixarit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy: 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
from baseline to end of treatment (3 weeks)
Safety: number of clinician-rated adverse events
Time Frame: from 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
from consent until end of study (approximately 9 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from baseline to end of treatment (3 weeks)
sleep (Insomnia Severity Index)
Time Frame: from baseline to end of treatment (3 weeks)
To evaluate changes in sleep
from baseline to end of treatment (3 weeks)
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.)
from baseline to end of treatment (3 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arkansas

Investigators

  • Principal Investigator: Allen C Sherman, PhD, Universitiy of Arkansas for Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Anticipated)

July 1, 2025

Study Completion (Anticipated)

September 1, 2026

Study Registration Dates

First Submitted

February 7, 2012

First Submitted That Met QC Criteria

February 7, 2012

First Posted (Estimate)

February 9, 2012

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 12, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 132500

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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