Back to resultsSolifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients
Primary Purpose
Hot Flashes, Breast Cancer
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
solifenacin
Clonidine
Sponsored by
About this trial
This is an interventional supportive care trial for Hot Flashes focused on measuring hot flashes, breast cancer, aromatase inhibitors, solifenacin, clonidine, quality of life
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)
Sites / Locations
- Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
solifenacin
clonidine
Arm Description
oral solifenacin 5.0 mg daily for 3 weeks
oral clonidine 0.1 mg daily for 3 weeks
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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
sleep (Insomnia Severity Index)
To evaluate changes in sleep
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.)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01530373
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2012 (undefined)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
September 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes, Breast Cancer
Keywords
hot flashes, breast cancer, aromatase inhibitors, solifenacin, clonidine, quality of life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
solifenacin
Arm Type
Experimental
Arm Description
oral solifenacin 5.0 mg daily for 3 weeks
Arm Title
clonidine
Arm Type
Active Comparator
Arm Description
oral clonidine 0.1 mg daily for 3 weeks
Intervention Type
Drug
Intervention Name(s)
solifenacin
Other Intervention Name(s)
Vesicare
Intervention Description
oral solifenacin 5.0 mg daily for 3 weeks
Intervention Type
Drug
Intervention Name(s)
Clonidine
Other Intervention Name(s)
Catapres, Dixarit
Intervention Description
oral clonidine 0.1 mg daily for 3 weeks
Primary Outcome Measure Information:
Title
Efficacy: hot flash composite and frequency scores (daily diary)
Description
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)
Title
Safety: number of clinician-rated adverse events
Description
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 Outcome Measure Information:
Title
daily functioning (Hot Flash-Related Daily Interference score)
Description
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)
Title
sleep (Insomnia Severity Index)
Description
To evaluate changes in sleep
Time Frame
from baseline to end of treatment (3 weeks)
Title
quality of life (Illness Cognition Questionnaire, SF-12)
Description
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)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allen C Sherman, PhD
Organizational Affiliation
Universitiy of Arkansas for Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
722205
Country
United States
12. IPD Sharing Statement
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Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients
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