Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients
This study is currently recruiting participants.
Verified March 2013 by University of Arkansas
Sponsor:
University of Arkansas
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01530373
First received: February 7, 2012
Last updated: March 7, 2013
Last verified: March 2013
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Hot Flashes Breast Cancer |
Drug: solifenacin Drug: Clonidine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | A Phase II Randomized Study of Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients Receiving Adjuvant Hormonal Therapy |
Resource links provided by NLM:
Further study details as provided by University of Arkansas:
Primary Outcome Measures:
- hot flash composite and frequency scores (daily diary) [ Time Frame: from baseline to end of treatment (3 weeks) ] [ Designated as safety issue: No ]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
- changes in number of clinician-rated adverse events [ Time Frame: from baseline to end of treatment (3 weeks) ] [ Designated as safety issue: Yes ]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) [ Time Frame: from baseline to end of treatment (3 weeks) ] [ Designated as safety issue: No ]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) [ Time Frame: from baseline to end of treatment (3 weeks) ] [ Designated as safety issue: No ]To evaluate changes in sleep
- quality of life (Illness Cognition Questionnaire, SF-12) [ Time Frame: from baseline to end of treatment (3 weeks) ] [ Designated as safety issue: No ]to evaluate changes in health-related quality of life. (Additional analyses will be observational, exploring associations between quality of life and meaning-making.)
| Estimated Enrollment: | 110 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | September 2016 |
| Estimated Primary Completion Date: | July 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: solifenacin
oral solifenacin 5.0 mg daily for 3 weeks
|
Drug: solifenacin
oral solifenacin 5.0 mg daily for 3 weeks
Other Name: Vesicare
|
|
Active Comparator: clonidine
oral clonidine 0.1 mg daily for 3 weeks
|
Drug: Clonidine
oral clonidine 0.1 mg daily for 3 weeks
Other Name: Catapres, Dixarit
|
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| Ages Eligible for Study: | 18 Years to 95 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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 greater than seven times per week
- Self-reported hot flashes for at least one month
Exclusion Criteria:
- Receiving any other treatment for hot flashes within the past month, including estrogens, progestins, androgens, gabapentin, or antidepressants such as venlafaxine, paroxetine, citalopram , sertraline, etc.
- 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 monoamine oxidase inhibitors, L-dopa, piribedil, barbiturates, moxifloxacin, pimozide, or antihypertensive treatment
- 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., clarithromycin, chloramphenicol, erythromycin, imatinib mesylate, Indinavir sulfate, itraconazole, ketoconazole, nefazodone, nelfinavir mesylate, ritonavir, telithromycin, troleandomycin).
- Uncontrolled or poorly controlled closed-angle glaucoma, urinary retention, gastric retention (evaluated from history & physical exam and medical record)
- Hypotension (systolic BP < 80)
- 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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01530373
Contacts
| Contact: Allen C Sherman, PhD | 501-686-8700 | shermanallenc@uams.edu |
| Contact: Suzanne Klimberg, MD | 501-536-6990 | klimbergsuzanne@uams.edu |
Locations
| United States, Arkansas | |
| Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical Sciences | Recruiting |
| Little Rock, Arkansas, United States, 722205 | |
| Contact: Laura L Adkins, MAP, CCRP 501-526-6990 lladkins@uams.edu | |
| Contact: Allen C Sherman, PhD 501-686-8700 shermanallenc@uams.edu | |
| Sub-Investigator: Suzanne Klimberg, MD | |
| Sub-Investigator: Maureen A McCarthy, RNP | |
| Sub-Investigator: Brian Badgwell, MD | |
| Sub-Investigator: Susan Kadlubar, PhD | |
Sponsors and Collaborators
University of Arkansas
Investigators
| Principal Investigator: | Allen C Sherman, PhD | Universitiy of Arkansas for Medical Sciences |
More Information
No publications provided
| Responsible Party: | University of Arkansas |
| ClinicalTrials.gov Identifier: | NCT01530373 History of Changes |
| Other Study ID Numbers: | 132500 |
| Study First Received: | February 7, 2012 |
| Last Updated: | March 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Arkansas:
|
hot flashes breast cancer aromatase inhibitors |
solifenacin clonidine quality of life |
Additional relevant MeSH terms:
|
Breast Neoplasms Hot Flashes Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Signs and Symptoms Clonidine Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate Aromatase Inhibitors Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Sympatholytics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Central Nervous System Agents Enzyme Inhibitors Muscarinic Antagonists Cholinergic Antagonists |
ClinicalTrials.gov processed this record on June 18, 2013