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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Arkansas
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01530373
First received: February 7, 2012
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Hot Flashes
Breast Cancer
Drug: solifenacin
Drug: Clonidine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • hot flash composite and frequency scores (daily diary) [ Time Frame: from baseline to end of treatment (3 weeks) ] [ Designated as safety issue: No ]
    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

  • number of clinician-rated adverse events [ Time Frame: from baseline to end of treatment (3 weeks) ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: from baseline to end of treatment (3 weeks) ] [ Designated as safety issue: No ]
    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) [ Time Frame: from baseline to end of treatment (3 weeks) ] [ Designated as safety issue: No ]
    To evaluate changes in sleep

  • quality of life (Illness Cognition Questionnaire, SF-12) [ Time Frame: from baseline to end of treatment (3 weeks) ] [ Designated as safety issue: No ]
    to evaluate changes in health-related quality of life. (Additional analyses will be observational, exploring associations between quality of life and meaning-making.)


Estimated Enrollment: 110
Study Start Date: February 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: solifenacin
oral solifenacin 5.0 mg daily for 3 weeks
Drug: solifenacin
oral solifenacin 5.0 mg daily for 3 weeks
Other Name: 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 Name: Catapres, Dixarit

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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530373

Contacts
Contact: Allen C Sherman, PhD 501-686-8700 shermanallenc@uams.edu
Contact: Suzanne Klimberg, MD 501-536-6990 klimbergsuzanne@uams.edu

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

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01530373     History of Changes
Other Study ID Numbers: 132500
Study First Received: February 7, 2012
Last Updated: May 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Arkansas:
hot flashes
breast cancer
aromatase inhibitors
solifenacin
clonidine
quality of life

Additional relevant MeSH terms:
Breast Neoplasms
Hot Flashes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms
Clonidine
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Aromatase Inhibitors
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Central Nervous System Agents
Enzyme Inhibitors
Muscarinic Antagonists
Cholinergic Antagonists

ClinicalTrials.gov processed this record on July 29, 2014