Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Arkansas
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
solifenacin
Drugoral solifenacin 5.0 mg daily for 3 weeks
Clonidine
Drugoral clonidine 0.1 mg daily for 3 weeks
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: solifenacinExperimental treatment 1 intervention
Group B: clonidineActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Efficacy: hot flash composite and frequency scores (daily diary)
to evaluate changes in hot flash composite and frequency scores for women receiving 3 weeks of oral solifenacin compared to those receiving 3 weeks of oral clonidine
Time frame
from baseline to end of treatment (3 weeks)2
Safety: number of clinician-rated adverse events
to evaluate changes in number of adverse events for women receiving 3 weeks of oral solifenacin compared to those receiving 3 weeks of oral clonidine
Time frame
from consent until end of study (approximately 9 weeks)Secondary outcomes
1
daily functioning (Hot Flash-Related Daily Interference score)
to evaluate changes in daily functioning (Hot Flash-Related Daily Interference Score) for women receiving 3 weeks of oral solifenacin compared to those receiving 3 weeks of oral clonidine
Time frame
from baseline to end of treatment (3 weeks)2
sleep (Insomnia Severity Index)
To evaluate changes in sleep
Time frame
from baseline to end of treatment (3 weeks)3
quality of life (Illness Cognition Questionnaire, SF-12)
to evaluate changes in health-related quality of life. (Additional analyses will be observational, exploring associations between quality of life and meaning-making.)
Time frame
from baseline to end of treatment (3 weeks)Sponsors and contacts
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Source ClinicalTrials.gov