Comparing solifenacin and clonidine for treating hot flashes in breast cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of solifenacin, a muscarinic acetylcholine receptor antagonist, in reducing hot flashes among women with breast cancer who are undergoing hormonal therapy. It compares the safety and efficacy of solifenacin to clonidine, a medication commonly used for hot flashes. Participants will receive either treatment for three weeks, and their hot flash frequency will be monitored. The study aims to provide new insights into managing this common side effect of breast cancer treatment.

Why it matters

Who can join: the full rules

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 hot flashes for at least one month
* If receiving non-tricyclic antidepressants (venlafaxine, paroxetine, citalopram, sertraline, etc.) or gabapentin, no change in regimen in past 4 weeks.

Exclusion Criteria:

* Receiving any other treatment for hot flashes within the past month, including estrogens, progestins, androgens, or gabapentin.
* 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 tricyclic antidepressants, monoamine oxidase inhibitors, barbiturates, pimozide.
* 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).
* Uncontrolled or poorly controlled narrow-angle glaucoma, urinary retention, gastric retention (evaluated from history \& physical exam and medical record)
* Hypotension or uncontrolled hypertension (160/95 \> BP \< 100/60)
* 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)

Where it's running

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

Study contacts

• Principal investigator: Allen C Sherman, PhD — Universitiy of Arkansas for Medical Sciences
• Study coordinator: Allen C Sherman, PhD
• Email: shermanallenc@uams.edu
• Phone: 501-686-8700

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.