Trial intelligence / Profile preview

Oxybutynin for Hot Flashes in Breast Cancer Patients

NCT02961790Phase 3

Key facts

Status: Completed
Start: Dec 2016
Primary completion: Apr 2018
Countries: 1
Sponsor: Academic and Community Cancer Research United
Modality: Small Molecules

Drugs: oxybutynin
Conditions: hot flashes

Overview

Phase 3, randomised, double-blind trial of oxybutynin in hot flashes (4 arms), sponsored by Academic and Community Cancer Research United. Primary endpoint: Average Change in Hot Flash Activity Score at 7 weeks. Started Dec 2016; status: completed.

Design

4 arms

Study design: RandomizedDouble-blind

Low-dose Oxybutynin
Low-dose oxybutynin BID Days 8-49
Low-dose Placebo
Low-dose placebo BID Days 8-49
High-dose Oxybutynin
Low-dose oxybutynin BID Days 8-14, then high-dose BID Days 15-49
High-dose Placebo
Low-dose placebo BID Days 8-14, then high-dose BID Days 15-49

Who it enrols

Women with bothersome hot flashes (>= 28/week) for > 30 days, with a history of breast cancer or concern about estrogen therapy.

Endpoints

Primary

Average Change in Hot Flash Activity Score7 weeks

Secondary

Average Change in Hot Flash Score From Week 1 to Week 7 Comparing Low Dose Oxybutynin to Placebo7 weeks
Average Change in Hot Flash Score From Week 1 to Week 7 Comparing High Dose Oxybutynin to Placebo7 weeks
Average Change of Severity of Stomach Pain/Cramps Symptoms as Measured by the Symptom Experience Questionnaire7 weeks
Average Change of Daily Interference (Work) as Measured by the Hot Flash-Related Daily Interference Scale7 weeks
Toxicity Assessed Using NCI CTCAE v4.07 weeks

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