NCT02961790

Oxybutynin Chloride in Managing Hot Flashes

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Academic and Community Cancer Research United · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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. ADAM-VTE

Detailed description

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.

Conditions

• Breast Carcinoma
• Ductal Breast Carcinoma In Situ
• Hot Flashes
• Lobular Breast Carcinoma In Situ
• No Evidence of Disease

Interventions

Type	Name	Description
DRUG	Oxybutynin Chloride	Given PO
OTHER	Placebo	Given PO
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2016-12-09
• Primary completion: 2018-04-27
• Completion: 2018-04-27
• First posted: 2016-11-11
• Last updated: 2020-01-18
• Results posted: 2019-06-03

Locations

13 sites across 1 country: United States