Solifenacin vs Clonidine for Breast Cancer Hot Flashes

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

Recruiting Phase 2 Interventional Study
Hot Flashes Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Supportive Care
Participants needed
110 (estimated)
Sponsor
University of Arkansas · Other
Who this trial is looking for

This trial is looking for women with a history of breast cancer who have hot flashes. Participants will take either solifenacin or clonidine to see which is more effective in reducing their symptoms.

Are You a Good Fit for This Trial?
Must be taking Aromatase inhibitorsTamoxifen
Must not be taking ClonidineSolifenacin
Rules you out Severe renal impairmentModerate or severe hepatic impairmentNarrow-angle glaucomaUncontrolled hypertensionSevere coronary insufficiency

You may be able to join if

  • I am a woman with a history of invasive breast cancer or DCIS.
  • I am currently taking aromatase inhibitors or tamoxifen.
  • I have not received hormone replacement therapy for at least one month.
  • I am 18 years or older.
  • I have hot flashes at least fourteen times per week.
  • I have been experiencing hot flashes for at least one month.
  • I have not changed my non-tricyclic antidepressants or gabapentin regimen in the past 4 weeks.

You may not be able to join if

  • I have received treatment for hot flashes in the past month.
  • I am currently using clonidine or solifenacin.
  • I have a history of severe renal or moderate or severe liver problems.
  • I am receiving or planning to receive chemotherapy or radiotherapy within the next 3 months.
  • I am currently using tricyclic antidepressants or certain other specific medications.
  • I have uncontrolled or poorly controlled narrow-angle glaucoma, urinary or gastric retention.
  • I have low blood pressure or high blood pressure.
  • I have serious heart problems, recent heart attack, or stroke issues.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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).

Trial Locations
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Eligibility 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 at least fourteen times per week * Self-reported…
Contacts

Allen C Sherman, PhD

501-686-8700

shermanallenc@uams.edu

CONTACT