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

Phase 2
18 Years
95 Years
Open (Enrolling)
Hot Flashes, Breast Cancer

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Trial Information

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

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.

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)

Type of Study:


Study Design:

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

Outcome Measure:

hot flash composite and frequency scores (daily diary)

Outcome Description:

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

Outcome Time Frame:

from baseline to end of treatment (3 weeks)

Safety Issue:


Principal Investigator

Allen C Sherman, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universitiy of Arkansas for Medical Sciences


United States: Food and Drug Administration

Study ID:




Start Date:

February 2012

Completion Date:

September 2016

Related Keywords:

  • Hot Flashes
  • Breast Cancer
  • hot flashes
  • breast cancer
  • aromatase inhibitors
  • solifenacin
  • clonidine
  • quality of life
  • Breast Neoplasms
  • Hot Flashes



Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical Sciences Little Rock, Arkansas  722205