Comparing solifenacin and clonidine for treating hot flashes in breast cancer patients
A Phase II Randomized Study of Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients Receiving Adjuvant Hormonal Therapy
This study tests whether solifenacin can help reduce hot flashes in women with breast cancer undergoing hormonal therapy, comparing it to clonidine to see which works better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Arkansas Academic / other |
| Drugs / interventions | imatinib, chemotherapy |
| Locations | 1 site (Little Rock, Arkansas) |
| Trial ID | NCT01530373 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with a history of invasive breast cancer or DCIS, currently taking aromatase inhibitors or tamoxifen, and experiencing frequent hot flashes.
Not a fit: Patients currently receiving other treatments for hot flashes or those with severe renal or hepatic impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new treatment option for breast cancer patients suffering from debilitating hot flashes.
How similar studies have performed: While there is ongoing interest in managing hot flashes in breast cancer patients, this specific comparison of solifenacin and clonidine is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Little Rock, Arkansas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.