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New treatment option for Breast Cancer
Official title REDucing Hot FLASHes in Women Using Endocrine Therapy.
ClinicalTrials.gov ID: NCT06106529
What this study is testing
What is Oxybutynin?
Oxybutynin is an investigational medicine, given as an once-daily, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 15 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- Experiencing hot flashes with a minimum of 14 per week for at least 1 month and desire to start a pharmacologic intervention.
You likely can't join if
- Pregnant;
- Breast feeding;
- Patients who receive chemotherapy or immunotherapy/HER2 antibodies within the prior 8 weeks, and patients scheduled for chemotherapy during the study...
- Palliative setting;
- Use of venlafaxine or any other antidepressants, also including St. John's wort within the previous year;
- Creatinine clearance \< 30 ml/min;
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Delft, South Holland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 15 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Delft, South Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.