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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01530373
• Other study ID #: 132500
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 2012
• Est. completion date: September 2027

Study information

• Verified date: May 2024
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: September 2027
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Hot Flashes

Intervention

Drug:
• solifenacin
oral solifenacin 5.0 mg daily for 3 weeks
• Clonidine
oral clonidine 0.1 mg daily for 3 weeks

Locations

Country	Name	City	State
United States	Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: hot flash composite and frequency scores (daily diary)	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)
Primary	Safety: number of clinician-rated adverse events	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	daily functioning (Hot Flash-Related Daily Interference score)	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)
Secondary	sleep (Insomnia Severity Index)	To evaluate changes in sleep	from baseline to end of treatment (3 weeks)
Secondary	quality of life (Illness Cognition Questionnaire, SF-12)	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)