Clinical trial NCT01530373: Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients
Official title: A Phase II Randomized Study of Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients Receiving Adjuvant Hormonal Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hot Flashes
Breast Cancer
Keywords: hot flashes
breast cancer
aromatase inhibitors
solifenacin
clonidine
quality of life
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2012-02-09
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Detailed description: There has been considerable interest in developing new treatment strategies for managing hot flashes among women with breast cancer, in view of the limitations associated with currently available treatments. This randomized study evaluates the safety and efficacy of 3 weeks of solifenacin compared to 3 weeks of clonidine, for women receiving adjuvant hormonal therapy (aromatase inhibitors or tamoxifen) for breast cancer.

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)

Primary outcomes:
measure: Efficacy: hot flash composite and frequency scores (daily diary)
timeFrame: from baseline to end of treatment (3 weeks)
measure: Safety: number of clinician-rated adverse events
timeFrame: from consent until end of study (approximately 9 weeks)
Secondary outcomes:
measure: daily functioning (Hot Flash-Related Daily Interference score)
timeFrame: from baseline to end of treatment (3 weeks)
measure: sleep (Insomnia Severity Index)
timeFrame: from baseline to end of treatment (3 weeks)
measure: quality of life (Illness Cognition Questionnaire, SF-12)
timeFrame: from baseline to end of treatment (3 weeks)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: Universitiy of Arkansas for Medical Sciences
name: Allen C Sherman, PhD
role: PRINCIPAL_INVESTIGATOR
References: