Clinical Trial

REDucing Hot FLASHes in Women Using Endocrine Therapy.

Study acronym: REDFLASH
Recruiting Phase 3
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-10-24; most recent amendment 2025-01-31.
Status change: Not Yet Recruiting → Recruiting 2025-01-31
Trial Details
NCT Number NCT06106529
Lead Sponsor Reinier de Graaf Groep
Conditions Breast Cancer, Hot Flash Due to Medication
Enrollment 260 participants
Start Date 2024-10-03
Primary Completion 2029-01-01 (estimated)
Study Completion 2029-01-01 (estimated)
Updated on ClinicalTrials.gov 2025-02-04