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REDucing Hot FLASHes in Women Using Endocrine Therapy.

RECRUITINGPhase 3Sponsored by Reinier de Graaf Groep
Actively Recruiting
PhasePhase 3
SponsorReinier de Graaf Groep
Started2024-10-03
Est. completion2029-01-01
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted

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 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.

Eligibility

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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.

Conditions3

Breast CancerCancerHot Flash Due to Medication

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