OncoMatch/Clinical Trials/NCT06106529
REDucing Hot FLASHes in Women Using Endocrine Therapy.
Is NCT06106529 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including Oxybutynin and Venlafaxine for breast cancer.
Treatment: Oxybutynin · Venlafaxine — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Breast Carcinoma
Demographics
Prior therapy
Must have received: endocrine therapy (tamoxifen, aromatase inhibitor, luteinizing hormone-releasing hormone analogue)
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
Cannot have received: chemotherapy
Patients who receive chemotherapy or immunotherapy/HER2 antibodies within the prior 8 weeks, and patients scheduled for chemotherapy during the study period
Cannot have received: immunotherapy
Patients who receive chemotherapy or immunotherapy/HER2 antibodies within the prior 8 weeks, and patients scheduled for chemotherapy during the study period
Cannot have received: HER2-targeted therapy
Patients who receive chemotherapy or immunotherapy/HER2 antibodies within the prior 8 weeks, and patients scheduled for chemotherapy during the study period
Cannot have received: antidepressant (venlafaxine, St. John's wort)
Use of venlafaxine or any other antidepressants, also including St. John's wort within the previous year
Cannot have received: anticonvulsant (gabapentin)
Use of gabapentin and/or calcium channel antagonists within 2 weeks of study entry
Cannot have received: calcium channel antagonist
Use of gabapentin and/or calcium channel antagonists within 2 weeks of study entry
Cannot have received: (oxybutynin)
Use of oxybutynin before study entry
Cannot have received:
Use of any other substances or therapies for the treatment of hot flashes, for instance acupuncture
Lab requirements
Kidney function
Creatinine clearance < 30 ml/min excluded
Liver function
Liver cirrhosis excluded
Creatinine clearance < 30 ml/min; Liver cirrhosis
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06106529 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy, immunotherapy, HER2-targeted therapy disqualifies patients from enrollment.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages