Clinical Trial: Oxybutynin Chloride in Managing Hot Flashes

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase III, Double-Blind, Controlled Trial of Oxybutynin in the Management of Hot Flashes

Brief Summary: This randomized phase III trial studies how well oxybutynin chloride works in managing hot flashes in patients who are not candidates for, or not interested in hormone replacement therapy. Previous studies have shown that oxybutynin is effective in managing hot flashes, however doses used in prior studies have resulted in side effects. This trial is evaluating lower doses of oxybutynin with the goal of determining if they are efficacious with less side effects.

Detailed Summary:

PRIMARY OBJECTIVES:

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.


Sponsor: Academic and Community Cancer Research United

Current Primary Outcome: Intra-patient changes of weekly hot flash activity [ Time Frame: Baseline up to day 49 ]

Estimates will be used to construct a 95% confidence interval for the mean difference in intra-patient changed of hot flashes between the treatment and placebo arms.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in weekly frequency and maximum severity of hot flashes as measured by the hot flash diary [ Time Frame: Baseline up to 2 years ]
    Will be compared using repeated measures models. Generalized estimating equations may be used to estimate model parameters.
  • Change of daily interference as measured by the Hot Flash Related Daily Interference Scale [ Time Frame: Baseline up to 2 years ]
    Will be first summarized by descriptive statistics and then compared across oxybutynin and placebo arms using Wilcoxon rank sum tests (or two sample t-tests).
  • Change of severity of symptoms as measured by the Symptom Experience Questionnaire [ Time Frame: Baseline up to 2 years ]
    Will be first summarized by descriptive statistics and then compared across oxybutynin and placebo arms using Wilcoxon rank sum tests (or two sample t-tests).
  • Incidence of adverse events as assessed by Common Terminology Criteria for Adverse Events version 4 [ Time Frame: Up to 2 years ]
    Chi-square tests (or Fisher's exact tests) will be used to evaluate the difference between oxybutynin and placebo arms.
  • Intra-patient changes in hot flash activity [ Time Frame: Baseline up to 2 years ]
    Will be compared between the two placebo arms using a repeated measures model of weekly hot flash score.


Original Secondary Outcome: Same as current

Information By: Academic and Community Cancer Research United

Dates:
Date Received: November 9, 2016
Date Started: December 2016
Date Completion: August 2018
Last Updated: May 17, 2017
Last Verified: May 2017