Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04600336
Status:
COMPLETED
Last Update Posted:
2024-06-26
First Post:
2020-10-19
Brief Title:
Testing the Effects of Oxybutynin for the Treatment of Hot Flashes in Men Receiving Hormone Therapy for Prostate Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Phase II Study of Oxybutynin Versus Placebo for the Treatment of Hot Flashes in Men Receiving Androgen Deprivation Therapy
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 ie 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 2211 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
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 ie 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 2211 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2020-07169 | REGISTRY | NCI Clinical Trial Reporting Program | httpsreporternihgovquickSearchUG1CA189823 |
| UG1CA189823 | NIH | None | None |