RecruitingPhase 2NCT01530373

Solifenacin Compared to Clonidine for Reducing Hot Flashes Among 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

Sponsor

University of Arkansas

Enrollment

110 participants

Start Date

Feb 1, 2012

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Hot Flashes

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria7

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 Criteria11

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)