Status:
RECRUITING
REDucing Hot FLASHes in Women Using Endocrine Therapy.
Lead Sponsor:
Reinier de Graaf Groep
Conditions:
Breast Cancer
Hot Flash Due to Medication
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT06106529
Start Date
October 3 2024
End Date
January 1 2029
Last Update
February 4 2025
Active Locations (1)
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1
Reinier de Graaf Gasthuis
Delft, South Holland, Netherlands, 2625 AD