REDucing Hot FLASHes in Women Using Endocrine Therapy.
Recruiting now · Phase 3
Conditions studied: Breast Cancer, Hot Flash Due to Medication
In brief
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.
Key facts
- Study ID
- NCT06106529
- Run by
- Reinier de Graaf Groep
- People needed
- 260
- Starts
- 2024-10-03
- Expected to finish
- 2029-01-01
- Last updated by the study team
- 2025-02-04
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Pre-, peri- or postmenopausal women of 18 years or above;
- Indication for endocrine therapy and already started with tamoxifen, aromatase inhibitors or luteinizing hormone-releasing hormone analogues for at least 4 weeks and planning to continue for the duration of the study;
- Experiencing hot flashes with a minimum of 14 per week for at least 1 month and desire to start a pharmacologic intervention.
You may not qualify if…
- Pregnant;
- Breast feeding;
- Patients who receive chemotherapy or immunotherapy/HER2 antibodies within the prior 8 weeks, and patients scheduled for chemotherapy during the study period;
- Palliative setting;
- Use of venlafaxine or any other antidepressants, also including St. John's wort within the previous year;
- Creatinine clearance < 30 ml/min;
- Liver cirrhosis;
- Use of gabapentin and/or calcium channel antagonists within 2 weeks of study entry;
- Use of oxybutynin before study entry;
- Use of any other substances or therapies for the treatment of hot flashes, for instance acupuncture.
Where it is running
- Reinier de Graaf Gasthuis — Delft, South Holland, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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