NCT06106529

REDucing Hot FLASHes in Women Using Endocrine Therapy.

A Randomized Intrapatient Cross-over Study to Assess the Efficacy of Oxybutynin Versus Venlafaxine in Reducing Hot Flashes in Women Using Endocrine Therapy After Breast Cancer.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Reinier de Graaf Groep · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this randomized intrapatient cross-over study is to assess the efficacy of oxybutynin versus venlafaxine in reducing hot flashes in women using endocrine therapy after breast cancer. The objectives it aims to answer are: * To assess the efficacy of oxybutynin versus venlafaxine in reducing hot flashes in women using endocrine therapy after breast cancer * To assess side effects of oxybutynin versus venlafaxine. * To assess the personal preference of women for oxybutynin versus venlafaxine in reducing hot flashes. * To assess quality of life of women when reducing hot flashes in women using endocrine therapy after breast cancer. Participants will fill-out a patient diary during 15 weeks total on a daily basis and receive an (online) questionnaire three times total. Researchers will compare two groups (venlafaxine group versus oxubutynine group) to assess its efficacy concerning hot flashes.

Conditions

• Breast Cancer
• Hot Flash Due to Medication

Interventions

Type	Name	Description
DRUG	Oxybutynin	Oxybutynin 5 mg twice per day for 6 weeks
DRUG	Venlafaxine	Venlafaxine 37.5 mg once daily for 7 days followed by 75 mg once daily for 5 weeks

Timeline

• Start date: 2024-10-03
• Primary completion: 2029-01-01
• Completion: 2029-01-01
• First posted: 2023-10-30
• Last updated: 2025-02-04

Locations

1 site across 1 country: Netherlands