Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
150 participants
INTERVENTIONAL
2016-12-09
2018-04-27
Brief Summary
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ADAM-VTE
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Detailed Description
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I. To determine whether oxybutynin chloride (oxybutynin) can diminish hot-flash activity in women with a history of breast cancer or in women who have a concern about taking estrogen for fear of breast cancer.
SECONDARY OBJECTIVES:
I. To perform a dose-response evaluation of two oxybutynin doses. II. To determine the toxicity of oxybutynin in the study population. III. To assess the impact of hot-flash activity on overall quality of life and to examine whether oxybutynin can diminish this impact on quality of life.
OUTLINE: Patients are randomized into 1 of 4 groups.
GROUP I (LOW-DOSE OXUBUTYNIN CHLORIDE): Patients receive lower dose oxybutynin chloride orally (PO) twice a day (BID) on days 8-49 in the absence of unacceptable toxicity.
GROUP II (LOW-DOSE PLACEBO): Patients receive lower dose placebo PO BID on days 8-49 in the absence of unacceptable toxicity.
GROUP III (HIGH-DOSE OXUBUTYNIN CHLORIDE): Patients receive lower dose oxybutynin chloride PO BID on days 8-14 and higher dose oxybutynin chloride on days 15-49 in the absence of unacceptable toxicity.
GROUP IV (HIGH-DOSE PLACEBO): Patients receive lower dose placebo PO BID on days 8-14 and higher dose placebo on days 15-49 in the absence of unacceptable toxicity.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Group I (low-dose oxybutynin chloride)
Patients receive lower dose oxybutynin chloride PO BID on days 8-49 in the absence of unacceptable toxicity.
Oxybutynin Chloride
Given PO
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Group II (low-dose placebo)
Patients receive lower dose placebo PO BID on days 8-49 in the absence of unacceptable toxicity.
Placebo
Given PO
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Group III (high-dose oxybutynin chloride)
Patients receive lower dose oxybutynin chloride PO BID on days 8-14 and higher dose oxybutynin chloride on days 15-49 in the absence of unacceptable toxicity.
Oxybutynin Chloride
Given PO
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Group IV (high-dose placebo)
Patients receive lower dose placebo PO BID on days 8-14 and higher dose placebo on days 15-49 in the absence of unacceptable toxicity.
Placebo
Given PO
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Oxybutynin Chloride
Given PO
Placebo
Given PO
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Bothersome hot flashes (defined by their occurrence of \>= 28 times per week and of sufficient severity to prompt the patient to seek therapeutic intervention)
* Presence of hot flashes for \> 30 days prior to study entry
* Ability to complete questionnaire(s) by themselves or with assistance
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 0, 1
* Ability to provide informed written consent
* Life expectancy \>= 6 months
* Willing to work with the enrolling institution for follow-up (during the active monitoring phase of the study)
Exclusion Criteria
* Antineoplastic chemotherapy (anti-HER2 agents allowed)
* Androgens
* Estrogens (any delivery route)
* Progestogens
* Tamoxifen, raloxifene and aromatase inhibitors are allowed, but patient must have been on a constant dose for at least 28 days and must not be expected to stop the medication during the study period
* Selective serotonin reuptake inhibitors (SSRIs)/serotonin?norepinephrine reuptake inhibitors (SNRIs), when being used for hot flash management or other indications such as depression, is allowed, assuming the dose will remain unchanged for the study duration
* Gabapentin/pregabalin, when being used for hot flash management (use for other indications, such as pain, is allowed, assuming the dose will remain unchanged for the study duration)
* Clonidine
* Agents with known potent anticholinergic activity; agents with mild-moderate anticholinergic activity are allowed
* Prior use of oxybutynin during the period in which patient has had hot flashes
* Pregnant women
* Nursing women
* History of any of the following contraindications to oxybutynin:
* Uncontrolled gastroesophageal reflux disease (GERD) despite appropriate therapy; if patient has history of GERD, but symptoms are well-controlled with medical treatment, patient is eligible
* Ulcerative colitis
* Narrow-angle glaucoma
* Urinary retention
* Hypersensitivity to oxybutynin or any other components of the product
* Current uncontrolled hyperthyroidism
* Coronary heart disease (angina or prior myocardial infarction)
* Congestive heart failure
* Symptomatic cardiac arrhythmias
* Current uncontrolled hypertension
* Myasthenia gravis
* Dementia
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Academic and Community Cancer Research United
OTHER
Responsible Party
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Principal Investigators
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Charles Loprinzi
Role: PRINCIPAL_INVESTIGATOR
Academic and Community Cancer Research United
Locations
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Illinois CancerCare-Peoria
Peoria, Illinois, United States
Carle Cancer Center NCI Community Oncology Research Program
Urbana, Illinois, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States
Saint Elizabeth Medical Center South
Edgewood, Kentucky, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Waverly Hematology Oncology
Cary, North Carolina, United States
AnMed Health Cancer Center
Anderson, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Saint Vincent Hospital -Green Bay
Green Bay, Wisconsin, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2016-01603
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACCRU-SC-1603
Identifier Type: OTHER
Identifier Source: secondary_id
ACCRU-SC-1603
Identifier Type: -
Identifier Source: org_study_id
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