OncoMatch/Clinical Trials/NCT01530373
Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients
Is NCT01530373 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including solifenacin and Clonidine for hot flashes.
Treatment: solifenacin · Clonidine — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: aromatase inhibitor
Currently taking aromatase inhibitors
Must have received: antiestrogen (tamoxifen)
Currently taking ... tamoxifen
Cannot have received: hormone replacement therapy
Exception: if not received for minimum of one month
Not receiving hormone replacement therapy for minimum of one month
Cannot have received: treatment for hot flashes (estrogens, progestins, androgens, gabapentin)
Exception: if not received within the past month
Receiving any other treatment for hot flashes within the past month, including estrogens, progestins, androgens, or gabapentin
Cannot have received: (clonidine, solifenacin)
Exception: if off for one month
Current use of clonidine or solifenacin. (If patients have been off of these for one month, then they are eligible)
Cannot have received: chemotherapy
Exception: if not concurrent or planned within next 3 months
Concurrent or planned chemotherapy (within next 3 months)
Cannot have received: radiation therapy
Exception: if not concurrent or planned within next 3 months
Concurrent or planned ... radiotherapy (within next 3 months)
Cannot have received: tricyclic antidepressant
Currently receiving tricyclic antidepressants
Cannot have received: monoamine oxidase inhibitor
Currently receiving ... monoamine oxidase inhibitors
Cannot have received: barbiturate
Currently receiving ... barbiturates
Cannot have received: (pimozide)
Currently receiving ... pimozide
Lab requirements
Kidney function
No severe renal impairment, as indicated by physical exam and medical record
Liver function
No moderate or severe hepatic impairment, as indicated by physical exam and medical record
Cardiac function
No severe coronary insufficiency, conduction disturbances, recent myocardial infarction (within past 3 months), cerebrovascular disease, syncope
History of severe renal or moderate or severe hepatic impairment, as indicated by physical exam and medical record; Severe coronary insufficiency, conduction disturbances, recent myocardial infarction (within past 3 months), cerebrovascular disease, syncope (evaluated from history & physical and medical record)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical Sciences · Little Rock, Arkansas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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