Testing the Effects of Oxybutynin for the Treatment of Hot Flashes in Men Receiving Hormone Therapy for Prostate Cancer
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- STATUS
- Recruiting
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- End date
- Mar 3, 2023
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- participants needed
- 87
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- sponsor
- Alliance for Clinical Trials in Oncology
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.
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.
ARM A: Patients receive low-dose oxybutynin chloride orally (PO) twice daily (BID) on days 8-49 (6 weeks) in the absence of unacceptable toxicity.
ARM B: Patients receive high-dose oxybutynin chloride PO BID on days 8-49 (6 weeks) in the absence of unacceptable toxicity.
ARM C: Patients receive low-dose placebo PO BID on days 8-49 (6 weeks). After 6 weeks, patients may cross over to Arm A per physician discretion.
ARM D: Patients receive high-dose placebo PO BID on days 8-49 (6 weeks). After 6 weeks, patients may cross over to Arm B per physician discretion.
There will be a 6-week follow-up for Arm C and Arm D patients who participate in the optional crossover phase.
Details
| Condition | Prostate Carcinoma |
|---|---|
| Treatment | questionnaire administration, quality-of-life assessment, Placebo Administration, Oxybutynin Chloride |
| Clinical Study Identifier | NCT04600336 |
| Sponsor | Alliance for Clinical Trials in Oncology |
| Last Modified on | 3 May 2022 |
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