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

Sponsor

University of Arkansas (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01530373

Collaborator

(none)

Enrollment

Location

Arms

151

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Feb 1, 2012

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Efficacy: hot flash composite and frequency scores (daily diary) [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
Safety: number of clinician-rated adverse events [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

Secondary Outcome Measures

daily functioning (Hot Flash-Related Daily Interference score) [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) [from baseline to end of treatment (3 weeks)]
To evaluate changes in sleep
quality of life (Illness Cognition Questionnaire, SF-12) [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)