Breast Cancer Clinical Trial
Testing the Effects of Oxybutynin for the Treatment of Hot Flashes in Men Receiving Hormone Therapy for Prostate Cancer
Summary
This phase II trial compares the effect of oxybutynin versus placebo for reducing hot flashes in men receiving androgen deprivation (hormone) therapy for the treatment of prostate cancer . Androgen deprivation therapy decreases testosterone and other androgens through medications or surgical removal of the testicles. Relative to placebo, low- or high-dose oxybutynin may reduce hot flashes in men receiving androgen deprivation therapy.
Full Description
The primary and secondary objectives of the study:
PRIMARY OBJECTIVE:
I. To assess the effects of two doses of oxybutynin chloride (oxybutynin) on hot flash scores relative to placebo.
SECONDARY OBJECTIVES:
I. To assess study accrual rates and compliance with the therapy. II. To characterize the safety and adverse event profile of two doses of oxybutynin in the study population.
III. To evaluate the consistency of the results across the various methods used to evaluate the efficacy of oxybutynin (i.e., hot flash scores versus hot flash frequencies, mean differences versus 50% or greater reduction since baseline, single day versus full week to define patients' baseline hot flash scores).
IV. To compare patient-reported quality of life and hot flash interference, as measured by the Hot Flash Related Daily Interference Scale (HFRDIS), across arms.
V. To compare other changes in patient symptoms, as measured by the Symptom Experience Questionnaire, across arms.
OUTLINE: Patients are randomized to 1 of 4 arms in a 2:2:1:1 ratio according to the dynamic allocation scheme.
Experimental Arm (low dose): Patients receive low-dose oxybutynin chloride orally (PO) twice daily (BID) on days 8-49 (6 weeks) in the absence of unacceptable toxicity.
Experimental Arm (high dose): Patients receive high-dose oxybutynin chloride PO BID on days 8-49 (6 weeks) in the absence of unacceptable toxicity.
Placebo Arm (low dose): Patients receive low-dose placebo PO BID on days 8-49 (6 weeks). After 6 weeks, patients may cross over to Experimental Arm (low dose) per physician discretion.
Placebo Arm (high dose): Patients receive high-dose placebo PO BID on days 8-49 (6 weeks). After 6 weeks, patients may cross over to Experimental Arm (high dose) per physician discretion.
There will be a 6-week follow-up for the Placebo Arm patients who participate in the optional crossover phase.
Eligibility Criteria
Inclusion Criteria:
Men who are currently receiving androgen deprivation therapy (ADT) for the treatment of prostate cancer. ADT is defined by a history of orchiectomy, or ongoing usage of gonadotropin-releasing hormone agonists or antagonists. Men receiving next generation androgen axis inhibitor therapies including abiraterone, enzalutamide, apalutamide, and darolutamide are eligible
Patients must be on a stable dose of all hormone-directed therapies for at least 28 days prior to registration and must not be planning to discontinue this therapy for at least 42 days following registration. Patients receiving radiation therapy during the study period are eligible
Eligible patient must have bothersome hot flashes for >= 14 days prior to registration, defined by an occurrence of >= 28 times per week and of sufficient severity to cause the patient to seek therapeutic intervention
Life expectancy of greater than 6 months
Eastern Cooperative Oncology Group (ECOG) performance status - 0, 1, or 2
In order to complete the mandatory patient-completed measures, participants must be able to speak and/or read English
Exclusion Criteria:
No current use or future planned use of any of the following agents during the study period: drugs that are not Food and Drug Administration (FDA) approved for use in humans, androgens, estrogens, progesterone analogs, gabapentin, selective serotonin reuptake inhibitor (SSRI)/serotonin and norepinephrine reuptake inhibitor (SNRI) anti-depressants, cholinergic agonists, cholinesterase inhibitors, or complementary/alternative medicine taken for the purpose of managing hot flashes. Prior use of these agents is permitted as long as they are discontinued before registration
No current or prior use of oxybutynin
Patients with a history of any of the following contraindications to oxybutynin are not eligible: gastroparesis or gastrointestinal obstructive disorders; significant gastric reflux symptoms not controlled by medication; ulcerative colitis; narrow-angle glaucoma; urinary retention requiring indwelling or intermittent self-catheterization within the prior 6 months; hypersensitivity to oxybutynin or any other components of the product; current uncontrolled hyperthyroidism; uncontrolled coronary artery disease or a history of myocardial infarction within the prior 12 months; New York Heart Association (NYHA) class II-IV congestive heart failure; symptomatic cardiac arrhythmias; current uncontrolled hypertension; myasthenia gravis; or dementia
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There are 89 Locations for this study
Gilbert Arizona, 85297, United States More Info
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Peoria Arizona, 85381, United States More Info
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Phoenix Arizona, 85004, United States More Info
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Phoenix Arizona, 85027, United States More Info
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Scottsdale Arizona, 85251, United States More Info
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Scottsdale Arizona, 85258, United States More Info
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Surprise Arizona, 85374, United States More Info
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Tucson Arizona, 85719, United States More Info
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Grand Junction Colorado, 81505, United States More Info
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Jacksonville Florida, 32207, United States More Info
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'Aiea Hawaii, 96701, United States More Info
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Honolulu Hawaii, 96813, United States More Info
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Danville Illinois, 61832, United States More Info
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Decatur Illinois, 62526, United States More Info
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Decatur Illinois, 62526, United States More Info
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Effingham Illinois, 62401, United States More Info
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Effingham Illinois, 62401, United States More Info
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Mattoon Illinois, 61938, United States More Info
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O'Fallon Illinois, 62269, United States More Info
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Springfield Illinois, 62702, United States More Info
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Springfield Illinois, 62702, United States More Info
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Springfield Illinois, 62781, United States More Info
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Urbana Illinois, 61801, United States More Info
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Ames Iowa, 50010, United States More Info
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Ames Iowa, 50010, United States More Info
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Boone Iowa, 50036, United States More Info
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Des Moines Iowa, 50309, United States More Info
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Des Moines Iowa, 50309, United States More Info
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Des Moines Iowa, 50314, United States More Info
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Fort Dodge Iowa, 50501, United States More Info
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Jefferson Iowa, 50129, United States More Info
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Marshalltown Iowa, 50158, United States More Info
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Flint Michigan, 48503, United States More Info
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Flint Michigan, 48503, United States More Info
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Flint Michigan, 48503, United States More Info
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Saginaw Michigan, 48601, United States More Info
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Saginaw Michigan, 48604, United States More Info
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Tawas City Michigan, 48764, United States More Info
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Burnsville Minnesota, 55337, United States More Info
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Burnsville Minnesota, 55337, United States More Info
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Coon Rapids Minnesota, 55433, United States More Info
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Edina Minnesota, 55435, United States More Info
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Fridley Minnesota, 55432, United States More Info
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Maple Grove Minnesota, 55369, United States More Info
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Maplewood Minnesota, 55109, United States More Info
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Maplewood Minnesota, 55109, United States More Info
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Minneapolis Minnesota, 55407, United States More Info
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Minneapolis Minnesota, 55415, United States More Info
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Monticello Minnesota, 55362, United States More Info
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New Ulm Minnesota, 56073, United States More Info
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Robbinsdale Minnesota, 55422, United States More Info
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Rochester Minnesota, 55905, United States More Info
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Saint Louis Park Minnesota, 55416, United States More Info
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Saint Paul Minnesota, 55101, United States More Info
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Saint Paul Minnesota, 55102, United States More Info
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Shakopee Minnesota, 55379, United States More Info
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Stillwater Minnesota, 55082, United States More Info
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Waconia Minnesota, 55387, United States More Info
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Willmar Minnesota, 56201, United States More Info
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Woodbury Minnesota, 55125, United States More Info
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Wyoming Minnesota, 55092, United States More Info
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Jackson Mississippi, 39216, United States More Info
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Columbia Missouri, 65212, United States More Info
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Rolla Missouri, 65401, United States More Info
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Omaha Nebraska, 68114, United States More Info
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Omaha Nebraska, 68114, United States More Info
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Cape May Court House New Jersey, 08210, United States More Info
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Egg Harbor Township New Jersey, 08234, United States More Info
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Bronx New York, 10461, United States More Info
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Bronx New York, 10461, United States More Info
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Bronx New York, 10467, United States More Info
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New York New York, 10065, United States More Info
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Asheville North Carolina, 28806, United States More Info
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Clinton North Carolina, 28328, United States More Info
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Goldsboro North Carolina, 27534, United States More Info
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Jacksonville North Carolina, 28546, United States More Info
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Fargo North Dakota, 58122, United States More Info
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Fargo North Dakota, 58122, United States More Info
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Grand Forks North Dakota, 58201, United States More Info
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Columbus Ohio, 43210, United States More Info
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Sioux Falls South Dakota, 57104, United States More Info
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Sioux Falls South Dakota, 57117, United States More Info
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Martinsville Virginia, 24115, United States More Info
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Antigo Wisconsin, 54409, United States More Info
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Appleton Wisconsin, 54915, United States More Info
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Brookfield Wisconsin, 53045, United States More Info
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Chilton Wisconsin, 53014, United States More Info
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Franklin Wisconsin, 53132, United States More Info
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Mequon Wisconsin, 53097, United States More Info
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Milwaukee Wisconsin, 53210, United States More Info
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Milwaukee Wisconsin, 53211, United States More Info
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Milwaukee Wisconsin, 53295, United States More Info
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Mukwonago Wisconsin, 53149, United States More Info
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New Richmond Wisconsin, 54017, United States More Info
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Oconomowoc Wisconsin, 53066, United States More Info
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Oshkosh Wisconsin, 54904, United States More Info
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Racine Wisconsin, 53405, United States More Info
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Waukesha Wisconsin, 53188, United States More Info
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Wausau Wisconsin, 54401, United States More Info
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Wauwatosa Wisconsin, 53226, United States More Info
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Wisconsin Rapids Wisconsin, 54494, United States More Info
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