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REDucing Hot FLASHes in Women Using Endocrine Therapy.

RecruitingPhase 3Ages 18 Years - anyFemaleReinier de Graaf Groep
NCT06106529 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 conce

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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.
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What it tests

  • Oxybutynin
  • Venlafaxine
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Where

1 site
Reinier de Graaf Gasthuis
Delft, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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