OncoMatch/Clinical Trials/NCT06106529
REDucing Hot FLASHes in Women Using Endocrine Therapy.
Is NCT06106529 recruiting? Yes, currently enrolling (May 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
Cancer type
Breast Carcinoma
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.
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