RECRUITING

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

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Conditions

Hot FlashesBreast Canceraromatase inhibitorssolifenacinclonidinequality of life

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2012-02
Study Completion:2027-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01530373

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women with a history of invasive breast cancer or DCIS
  2. * Currently taking aromatase inhibitors or tamoxifen
  3. * Not receiving hormone replacement therapy for minimum of one month
  4. * Age 18 years or older
  5. * Self-reported hot flashes at least fourteen times per week
  6. * Self-reported hot flashes for at least one month
  7. * If receiving non-tricyclic antidepressants (venlafaxine, paroxetine, citalopram, sertraline, etc.) or gabapentin, no change in regimen in past 4 weeks.
  1. * Receiving any other treatment for hot flashes within the past month, including estrogens, progestins, androgens, or gabapentin.
  2. * Current use of clonidine or solifenacin. (If patients have been off of these for one month, then they are eligible)
  3. * History of severe renal or moderate or severe hepatic impairment, as indicated by physical exam and medical record
  4. * Concurrent or planned chemotherapy or radiotherapy (within next 3 months)
  5. * Currently receiving tricyclic antidepressants, monoamine oxidase inhibitors, barbiturates, pimozide.
  6. * 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).
  7. * Uncontrolled or poorly controlled narrow-angle glaucoma, urinary retention, gastric retention (evaluated from history \& physical exam and medical record)
  8. * Hypotension or uncontrolled hypertension (160/95 \> BP \< 100/60)
  9. * Severe coronary insufficiency, conduction disturbances, recent myocardial infarction (within past 3 months), cerebrovascular disease, syncope (evaluated from history \& physical and medical record)
  10. * History of allergy or adverse reactions to clonidine or solifenacin
  11. * ECOG status \> 2 (in bed more than 50% of day)

Contacts and Locations

Study Contact

Allen C Sherman, PhD
CONTACT
501-686-8700
shermanallenc@uams.edu

Principal Investigator

Allen C Sherman, PhD
PRINCIPAL_INVESTIGATOR
Universitiy of Arkansas for Medical Sciences

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Arkansas

  • Allen C Sherman, PhD, PRINCIPAL_INVESTIGATOR, Universitiy of Arkansas for Medical Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2012-02
Study Completion Date2027-09

Study Record Updates

Study Start Date2012-02
Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Hot Flashes
  • Breast Cancer