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

Who is this study for? Patients with Breast Cancer
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arkansas
Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical Sciences
RECRUITING
Little Rock
Contact Information
Primary
Allen C Sherman, PhD
shermanallenc@uams.edu
501-686-8700
Time Frame
Start Date: 2012-02
Estimated Completion Date: 2027-09
Participants
Target number of participants: 110
Treatments
Experimental: solifenacin
oral solifenacin 5.0 mg daily for 3 weeks
Active_comparator: clonidine
oral clonidine 0.1 mg daily for 3 weeks
Authors
Susan Kadlubar, Laura Hutchins
Related Therapeutic Areas
Sponsors
Leads: University of Arkansas

This content was sourced from clinicaltrials.gov

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