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

Information source: University of Arkansas
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hot Flashes; Breast Cancer

Intervention: solifenacin (Drug); Clonidine (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Arkansas

Official(s) and/or principal investigator(s):
Allen C Sherman, PhD, Principal Investigator, Affiliation: Universitiy of Arkansas for Medical Sciences

Overall contact:
Allen C Sherman, PhD, Phone: 501-686-8700, Email: shermanallenc@uams.edu


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).

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Primary outcome:

hot flash composite and frequency scores (daily diary)

number of clinician-rated adverse events

Secondary outcome:

daily functioning (Hot Flash-Related Daily Interference score)

sleep (Insomnia Severity Index)

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

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.


Minimum age: 18 Years. Maximum age: 95 Years. Gender(s): Female.


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 greater than seven times per week

- Self-reported hot flashes for at least one month

Exclusion Criteria:

- Receiving any other treatment for hot flashes within the past month, including

estrogens, progestins, androgens, gabapentin, or antidepressants such as venlafaxine, paroxetine, citalopram , sertraline, etc.

- 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 monoamine oxidase inhibitors, L-dopa, piribedil, barbiturates,

moxifloxacin, pimozide, or antihypertensive treatment

- 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., clarithromycin, chloramphenicol, erythromycin, imatinib mesylate, Indinavir sulfate, itraconazole, ketoconazole, nefazodone, nelfinavir mesylate, ritonavir, telithromycin, troleandomycin).

- Uncontrolled or poorly controlled closed-angle glaucoma, urinary retention, gastric

retention (evaluated from history & physical exam and medical record)

- Hypotension (systolic BP < 80)

- 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)

Locations and Contacts

Allen C Sherman, PhD, Phone: 501-686-8700, Email: shermanallenc@uams.edu

Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical Sciences, Little Rock, Arkansas 722205, United States; Recruiting
Laura L Adkins, MAP, CCRP, Phone: 501-526-6990, Email: lladkins@uams.edu
Allen C Sherman, PhD, Phone: 501-686-8700, Email: shermanallenc@uams.edu
Suzanne Klimberg, MD, Sub-Investigator
Maureen A McCarthy, RNP, Sub-Investigator
Susan Kadlubar, PhD, Sub-Investigator
Issam Makhoul, MD, Sub-Investigator
Laura Hutchins, MD, Sub-Investigator
Additional Information

Starting date: February 2012
Last updated: May 26, 2015

Page last updated: August 23, 2015

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