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.

View Full Description

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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

87

Study ID:

NCT04600336

Recruitment Status:

Recruiting

Sponsor:

Alliance for Clinical Trials in Oncology

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 89 Locations for this study

See Locations Near You

Arizona Breast Cancer Specialists-Gilbert
Gilbert Arizona, 85297, United States More Info
Site Public Contact
Contact
480-922-4600
Justin Famoso
Principal Investigator
Arizona Center for Cancer Care-Peoria
Peoria Arizona, 85381, United States More Info
Site Public Contact
Contact
623-773-2873
Justin Famoso
Principal Investigator
Cancer Center at Saint Joseph's
Phoenix Arizona, 85004, United States More Info
Site Public Contact
Contact
602-406-0777
[email protected]
Richard L. Deming
Principal Investigator
Arizona Breast Cancer Specialists-Phoenix
Phoenix Arizona, 85027, United States More Info
Site Public Contact
Contact
480-922-4600
[email protected]
Justin Famoso
Principal Investigator
Arizona Breast Cancer Specialists
Scottsdale Arizona, 85251, United States More Info
Site Public Contact
Contact
480-922-4600
Justin Famoso
Principal Investigator
Arizona Breast Cancer Specialists-Scottsdale
Scottsdale Arizona, 85258, United States More Info
Site Public Contact
Contact
480-922-4600
Justin Famoso
Principal Investigator
Arizona Center for Cancer Care-Surprise
Surprise Arizona, 85374, United States More Info
Site Public Contact
Contact
888-823-5923
[email protected]
Justin Famoso
Principal Investigator
University of Arizona Cancer Center-North Campus
Tucson Arizona, 85719, United States More Info
Site Public Contact
Contact
800-327-2873
Edward P. Gelmann
Principal Investigator
Grand Valley Oncology
Grand Junction Colorado, 81505, United States More Info
Site Public Contact
Contact
970-644-4460
[email protected]
Erica D. Lovett Fournier
Principal Investigator
Baptist MD Anderson Cancer Center
Jacksonville Florida, 32207, United States More Info
Site Public Contact
Contact
904-202-7468
Anterpreet S. Neki
Principal Investigator
Hawaii Cancer Care - Savio
'Aiea Hawaii, 96701, United States More Info
Site Public Contact
Contact
808-539-2273
[email protected]
Ashley Springer
Principal Investigator
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu Hawaii, 96813, United States More Info
Site Public Contact
Contact
808-524-6115
i[email protected]
Ashley Springer
Principal Investigator
Carle on Vermilion
Danville Illinois, 61832, United States More Info
Site Public Contact
Contact
800-446-5532
[email protected]
Priyank P. Patel
Principal Investigator
Cancer Care Specialists of Illinois - Decatur
Decatur Illinois, 62526, United States More Info
Site Public Contact
Contact
217-876-4762
[email protected]
Bryan A. Faller
Principal Investigator
Decatur Memorial Hospital
Decatur Illinois, 62526, United States More Info
Site Public Contact
Contact
217-876-4762
[email protected]
Bryan A. Faller
Principal Investigator
Carle Physician Group-Effingham
Effingham Illinois, 62401, United States More Info
Site Public Contact
Contact
800-446-5532
[email protected]
Priyank P. Patel
Principal Investigator
Crossroads Cancer Center
Effingham Illinois, 62401, United States More Info
Site Public Contact
Contact
217-876-4762
[email protected]
Bryan A. Faller
Principal Investigator
Carle Physician Group-Mattoon/Charleston
Mattoon Illinois, 61938, United States More Info
Site Public Contact
Contact
800-446-5532
[email protected]
Priyank P. Patel
Principal Investigator
Cancer Care Center of O'Fallon
O'Fallon Illinois, 62269, United States More Info
Site Public Contact
Contact
217-876-4762
[email protected]
Bryan A. Faller
Principal Investigator
Southern Illinois University School of Medicine
Springfield Illinois, 62702, United States More Info
Site Public Contact
Contact
217-545-7929
Bryan A. Faller
Principal Investigator
Springfield Clinic
Springfield Illinois, 62702, United States More Info
Site Public Contact
Contact
800-444-7541
Bryan A. Faller
Principal Investigator
Memorial Medical Center
Springfield Illinois, 62781, United States More Info
Site Public Contact
Contact
217-528-7541
[email protected]
Bryan A. Faller
Principal Investigator
Carle Cancer Center
Urbana Illinois, 61801, United States More Info
Site Public Contact
Contact
800-446-5532
[email protected]
Priyank P. Patel
Principal Investigator
Mary Greeley Medical Center
Ames Iowa, 50010, United States More Info
Site Public Contact
Contact
515-956-4132
Debra M. Prow
Principal Investigator
McFarland Clinic PC - Ames
Ames Iowa, 50010, United States More Info
Site Public Contact
Contact
515-239-4734
[email protected]
Debra M. Prow
Principal Investigator
McFarland Clinic PC-Boone
Boone Iowa, 50036, United States More Info
Site Public Contact
Contact
515-956-4132
Debra M. Prow
Principal Investigator
Iowa Methodist Medical Center
Des Moines Iowa, 50309, United States More Info
Site Public Contact
Contact
515-241-6727
Joshua Lukenbill
Principal Investigator
Medical Oncology and Hematology Associates-Des Moines
Des Moines Iowa, 50309, United States More Info
Site Public Contact
Contact
515-241-3305
Joshua Lukenbill
Principal Investigator
Mercy Medical Center - Des Moines
Des Moines Iowa, 50314, United States More Info
Site Public Contact
Contact
515-358-6613
[email protected]
Richard L. Deming
Principal Investigator
McFarland Clinic PC-Trinity Cancer Center
Fort Dodge Iowa, 50501, United States More Info
Site Public Contact
Contact
515-956-4132
Debra M. Prow
Principal Investigator
McFarland Clinic PC-Jefferson
Jefferson Iowa, 50129, United States More Info
Site Public Contact
Contact
515-956-4132
Debra M. Prow
Principal Investigator
McFarland Clinic PC-Marshalltown
Marshalltown Iowa, 50158, United States More Info
Site Public Contact
Contact
515-956-4132
Debra M. Prow
Principal Investigator
Genesee Cancer and Blood Disease Treatment Center
Flint Michigan, 48503, United States More Info
Site Public Contact
Contact
810-762-8038
[email protected]
Tareq Al Baghdadi
Principal Investigator
Genesee Hematology Oncology PC
Flint Michigan, 48503, United States More Info
Site Public Contact
Contact
810-762-8038
[email protected]
Tareq Al Baghdadi
Principal Investigator
Genesys Hurley Cancer Institute
Flint Michigan, 48503, United States More Info
Site Public Contact
Contact
810-762-8038
[email protected]
Tareq Al Baghdadi
Principal Investigator
Ascension Saint Mary's Hospital
Saginaw Michigan, 48601, United States More Info
Site Public Contact
Contact
989-907-8411
[email protected]
Tareq Al Baghdadi
Principal Investigator
Oncology Hematology Associates of Saginaw Valley PC
Saginaw Michigan, 48604, United States More Info
Site Public Contact
Contact
989-907-8411
[email protected]
Tareq Al Baghdadi
Principal Investigator
Ascension Saint Joseph Hospital
Tawas City Michigan, 48764, United States More Info
Site Public Contact
Contact
989-907-8411
[email protected]
Tareq Al Baghdadi
Principal Investigator
Fairview Ridges Hospital
Burnsville Minnesota, 55337, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
Daniel M. Anderson
Principal Investigator
Minnesota Oncology - Burnsville
Burnsville Minnesota, 55337, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
Daniel M. Anderson
Principal Investigator
Mercy Hospital
Coon Rapids Minnesota, 55433, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
Daniel M. Anderson
Principal Investigator
Fairview Southdale Hospital
Edina Minnesota, 55435, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
Daniel M. Anderson
Principal Investigator
Unity Hospital
Fridley Minnesota, 55432, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
Daniel M. Anderson
Principal Investigator
Fairview Clinics and Surgery Center Maple Grove
Maple Grove Minnesota, 55369, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
Daniel M. Anderson
Principal Investigator
Minnesota Oncology Hematology PA-Maplewood
Maplewood Minnesota, 55109, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
Daniel M. Anderson
Principal Investigator
Saint John's Hospital - Healtheast
Maplewood Minnesota, 55109, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
Daniel M. Anderson
Principal Investigator
Abbott-Northwestern Hospital
Minneapolis Minnesota, 55407, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
Daniel M. Anderson
Principal Investigator
Hennepin County Medical Center
Minneapolis Minnesota, 55415, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
Daniel M. Anderson
Principal Investigator
Monticello Cancer Center
Monticello Minnesota, 55362, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
Daniel M. Anderson
Principal Investigator
New Ulm Medical Center
New Ulm Minnesota, 56073, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
Daniel M. Anderson
Principal Investigator
North Memorial Medical Health Center
Robbinsdale Minnesota, 55422, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
Daniel M. Anderson
Principal Investigator
Mayo Clinic in Rochester
Rochester Minnesota, 55905, United States More Info
Site Public Contact
Contact
855-776-0015
Bradley J. Stish
Principal Investigator
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park Minnesota, 55416, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
Daniel M. Anderson
Principal Investigator
Regions Hospital
Saint Paul Minnesota, 55101, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
Daniel M. Anderson
Principal Investigator
United Hospital
Saint Paul Minnesota, 55102, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
Daniel M. Anderson
Principal Investigator
Saint Francis Regional Medical Center
Shakopee Minnesota, 55379, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
Daniel M. Anderson
Principal Investigator
Lakeview Hospital
Stillwater Minnesota, 55082, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
Daniel M. Anderson
Principal Investigator
Ridgeview Medical Center
Waconia Minnesota, 55387, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
Daniel M. Anderson
Principal Investigator
Rice Memorial Hospital
Willmar Minnesota, 56201, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
Daniel M. Anderson
Principal Investigator
Minnesota Oncology Hematology PA-Woodbury
Woodbury Minnesota, 55125, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
Daniel M. Anderson
Principal Investigator
Fairview Lakes Medical Center
Wyoming Minnesota, 55092, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
Daniel M. Anderson
Principal Investigator
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States More Info
Site Public Contact
Contact
601-815-6700
John C. Henegan
Principal Investigator
University of Missouri - Ellis Fischel
Columbia Missouri, 65212, United States More Info
Site Public Contact
Contact
573-882-7440
Katie S. Murray
Principal Investigator
Delbert Day Cancer Institute at PCRMC
Rolla Missouri, 65401, United States More Info
Site Public Contact
Contact
573-458-7504
[email protected]
Jay W. Carlson
Principal Investigator
Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
Omaha Nebraska, 68114, United States More Info
Site Public Contact
Contact
402-334-4773
Ralph J. Hauke
Principal Investigator
Nebraska Methodist Hospital
Omaha Nebraska, 68114, United States More Info
Site Public Contact
Contact
402-354-5144
Ralph J. Hauke
Principal Investigator
AtlantiCare Health Park-Cape May Court House
Cape May Court House New Jersey, 08210, United States More Info
Site Public Contact
Contact
609-677-7735
Neha R. Chawla
Principal Investigator
AtlantiCare Surgery Center
Egg Harbor Township New Jersey, 08234, United States More Info
Site Public Contact
Contact
609-748-7200
Neha R. Chawla
Principal Investigator
Montefiore Medical Center-Einstein Campus
Bronx New York, 10461, United States More Info
Site Public Contact
Contact
718-379-6866
[email protected]
Benjamin A. Gartrell
Principal Investigator
Montefiore Medical Center-Weiler Hospital
Bronx New York, 10461, United States More Info
Site Public Contact
Contact
718-379-6866
[email protected]
Benjamin A. Gartrell
Principal Investigator
Montefiore Medical Center - Moses Campus
Bronx New York, 10467, United States More Info
Site Public Contact
Contact
718-379-6866
[email protected]
Benjamin A. Gartrell
Principal Investigator
NYP/Weill Cornell Medical Center
New York New York, 10065, United States More Info
Site Public Contact
Contact
212-746-1848
Jones T. Nauseef
Principal Investigator
Messino Cancer Centers
Asheville North Carolina, 28806, United States More Info
Site Public Contact
Contact
828-212-7021
[email protected]
Christopher H. Chay
Principal Investigator
Southeastern Medical Oncology Center-Clinton
Clinton North Carolina, 28328, United States More Info
Site Public Contact
Contact
919-587-9084
[email protected]
Samer S. Kasbari
Principal Investigator
Southeastern Medical Oncology Center-Goldsboro
Goldsboro North Carolina, 27534, United States More Info
Site Public Contact
Contact
919-587-9084
[email protected]
Samer S. Kasbari
Principal Investigator
Southeastern Medical Oncology Center-Jacksonville
Jacksonville North Carolina, 28546, United States More Info
Site Public Contact
Contact
910-587-9084
[email protected]
Samer S. Kasbari
Principal Investigator
Sanford Broadway Medical Center
Fargo North Dakota, 58122, United States More Info
Site Public Contact
Contact
701-323-5760
[email protected]
Preston D. Steen
Principal Investigator
Sanford Roger Maris Cancer Center
Fargo North Dakota, 58122, United States More Info
Site Public Contact
Contact
701-234-6161
[email protected]
Preston D. Steen
Principal Investigator
Altru Cancer Center
Grand Forks North Dakota, 58201, United States More Info
Site Public Contact
Contact
701-780-6520
Grant R. Seeger
Principal Investigator
Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States More Info
Site Public Contact
Contact
800-293-5066
[email protected]
Dayssy A. Diaz Pardo
Principal Investigator
Sanford Cancer Center Oncology Clinic
Sioux Falls South Dakota, 57104, United States More Info
Site Public Contact
Contact
605-312-3320
[email protected]
Preston D. Steen
Principal Investigator
Sanford USD Medical Center - Sioux Falls
Sioux Falls South Dakota, 57117, United States More Info
Site Public Contact
Contact
605-312-3320
[email protected]
Preston D. Steen
Principal Investigator
Sovah Health Martinsville
Martinsville Virginia, 24115, United States More Info
Site Public Contact
Contact
276-666-7489
[email protected]
Brandon Mullins
Principal Investigator
Langlade Hospital and Cancer Center
Antigo Wisconsin, 54409, United States More Info
Site Public Contact
Contact
715-623-9869
[email protected]
Harish G. Ahuja
Principal Investigator
Ascension Saint Elizabeth Hospital
Appleton Wisconsin, 54915, United States More Info
Site Public Contact
Contact
414-635-6420
[email protected]
Ranveer Nand
Principal Investigator
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Brookfield Wisconsin, 53045, United States More Info
Site Public Contact
Contact
414-635-6420
[email protected]
Ranveer Nand
Principal Investigator
Ascension Calumet Hospital
Chilton Wisconsin, 53014, United States More Info
Site Public Contact
Contact
414-635-6420
[email protected]
Ranveer Nand
Principal Investigator
Ascension Saint Francis - Reiman Cancer Center
Franklin Wisconsin, 53132, United States More Info
Site Public Contact
Contact
414-635-6420
[email protected]
Ranveer Nand
Principal Investigator
Ascension Columbia Saint Mary's Hospital Ozaukee
Mequon Wisconsin, 53097, United States More Info
Site Public Contact
Contact
414-635-6420
[email protected]
Ranveer Nand
Principal Investigator
Ascension Southeast Wisconsin Hospital - Saint Joseph Campus
Milwaukee Wisconsin, 53210, United States More Info
Site Public Contact
Contact
414-635-6420
[email protected]
Ranveer Nand
Principal Investigator
Ascension Columbia Saint Mary's Hospital - Milwaukee
Milwaukee Wisconsin, 53211, United States More Info
Site Public Contact
Contact
414-635-6420
[email protected]
Ranveer Nand
Principal Investigator
Zablocki Veterans Administration Medical Center
Milwaukee Wisconsin, 53295, United States More Info
Site Public Contact
Contact
888-469-6614
Elizabeth M. Gore
Principal Investigator
ProHealth D N Greenwald Center
Mukwonago Wisconsin, 53149, United States More Info
Site Public Contact
Contact
[email protected]
Timothy R. Wassenaar
Principal Investigator
Cancer Center of Western Wisconsin
New Richmond Wisconsin, 54017, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
Daniel M. Anderson
Principal Investigator
ProHealth Oconomowoc Memorial Hospital
Oconomowoc Wisconsin, 53066, United States More Info
Site Public Contact
Contact
262-928-7878
Timothy R. Wassenaar
Principal Investigator
Ascension Mercy Hospital
Oshkosh Wisconsin, 54904, United States More Info
Site Public Contact
Contact
920-831-8900
[email protected]
Ranveer Nand
Principal Investigator
Ascension All Saints Hospital
Racine Wisconsin, 53405, United States More Info
Site Public Contact
Contact
414-635-6420
[email protected]
Ranveer Nand
Principal Investigator
UW Cancer Center at ProHealth Care
Waukesha Wisconsin, 53188, United States More Info
Site Public Contact
Contact
262-928-5539
[email protected]
Timothy R. Wassenaar
Principal Investigator
Aspirus Regional Cancer Center
Wausau Wisconsin, 54401, United States More Info
Site Public Contact
Contact
877-405-6866
Harish G. Ahuja
Principal Investigator
Ascension Medical Group Southeast Wisconsin - Mayfair Road
Wauwatosa Wisconsin, 53226, United States More Info
Site Public Contact
Contact
414-635-6420
[email protected]
Ranveer Nand
Principal Investigator
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids Wisconsin, 54494, United States More Info
Site Public Contact
Contact
715-422-7718
Harish G. Ahuja
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

87

Study ID:

NCT04600336

Recruitment Status:

Recruiting

Sponsor:


Alliance for Clinical Trials in Oncology

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.