RecruitingPhase 3NCT06106529

REDucing Hot FLASHes in Women Using Endocrine Therapy.

A Randomized Intrapatient Cross-over Study to Assess the Efficacy of Oxybutynin Versus Venlafaxine in Reducing Hot Flashes in Women Using Endocrine Therapy After Breast Cancer.


Sponsor

Reinier de Graaf Groep

Enrollment

260 participants

Start Date

Oct 3, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

The REDFLASH trial is testing medications to reduce hot flashes in women who are taking hormone-blocking therapy (endocrine therapy like tamoxifen or aromatase inhibitors) for breast cancer treatment. Hot flashes are a very common and disruptive side effect of these medications. **You may be eligible if...** - You are a woman (pre-, peri-, or postmenopausal), 18 or older - You are taking tamoxifen, an aromatase inhibitor, or a hormone-suppressing injection (LHRH analogue) for at least 4 weeks and plan to continue - You are having at least 14 hot flashes per week, for at least 1 month, and want to start treatment for them **You may NOT be eligible if...** - You are pregnant or breastfeeding - You are receiving chemotherapy or immunotherapy currently or recently (within 8 weeks) - You use antidepressants (including venlafaxine or St. John's Wort) within the past year - You have severely reduced kidney function or liver cirrhosis - You currently take gabapentin, calcium channel blockers, oxybutynin, or other hot flash treatments - Your cancer is being treated in a palliative (non-curative) setting Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOxybutynin

Oxybutynin 5 mg twice per day for 6 weeks

DRUGVenlafaxine

Venlafaxine 37.5 mg once daily for 7 days followed by 75 mg once daily for 5 weeks


Locations(1)

Reinier de Graaf Gasthuis

Delft, South Holland, Netherlands

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NCT06106529


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