NCT01530373 Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients
| NCT ID | NCT01530373 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Arkansas |
| Condition | Hot Flashes |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2012-02 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 110 participants in total. It began in 2012-02 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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 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)
Contact & Investigator
Allen C Sherman, PhD
PRINCIPAL INVESTIGATOR
Universitiy of Arkansas for Medical Sciences
Frequently Asked Questions
Who can join the NCT01530373 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Hot Flashes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT01530373 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT01530373 currently recruiting?
Yes, NCT01530373 is actively recruiting participants. Contact the research team at shermanallenc@uams.edu for enrollment information.
Where is the NCT01530373 trial being conducted?
This trial is being conducted at Little Rock, United States.
Who is sponsoring the NCT01530373 clinical trial?
NCT01530373 is sponsored by University of Arkansas. The principal investigator is Allen C Sherman, PhD at Universitiy of Arkansas for Medical Sciences. The trial plans to enroll 110 participants.