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

NCT01530373 | Recruiting Phase 2 DMC

• 1 other identifier: 132500
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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).

Conditions

Hot Flashes; Breast Cancer

Keywords

hot flashes; breast cancer; aromatase inhibitors; solifenacin; clonidine; quality of life

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (3)

• daily functioning (Hot Flash-Related Daily Interference score)

  from baseline to end of treatment (3 weeks)

• sleep (Insomnia Severity Index)

  from baseline to end of treatment (3 weeks)

• quality of life (Illness Cognition Questionnaire, SF-12)

  from baseline to end of treatment (3 weeks)

Study Arms (2)

solifenacin

EXPERIMENTAL

oral solifenacin 5.0 mg daily for 3 weeks

Drug: solifenacin

clonidine

ACTIVE COMPARATOR

oral clonidine 0.1 mg daily for 3 weeks

Drug: Clonidine

Interventions

solifenacin DRUG

oral solifenacin 5.0 mg daily for 3 weeks

Also known as: Vesicare

solifenacin

Clonidine DRUG

oral clonidine 0.1 mg daily for 3 weeks

Also known as: Catapres, Dixarit

clonidine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical Sciences

Little Rock, Arkansas, 722205, United States

RECRUITING

MeSH Terms

Conditions

Hot Flashes; Breast Neoplasms

Interventions

Solifenacin Succinate; Clonidine

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Allen C Sherman, PhD

  Universitiy of Arkansas for Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allen C Sherman, PhD

CONTACT

501-686-8700; shermanallenc@uams.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2012
• First Posted: February 9, 2012
• Study Start: February 1, 2012
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (1)