NCT06106529 REDucing Hot FLASHes in Women Using Endocrine Therapy.
| NCT ID | NCT06106529 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Reinier de Graaf Groep |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 260 participants |
| Start Date | 2024-10-03 |
| Primary Completion | 2029-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 260 participants in total. It began in 2024-10-03 with a primary completion date of 2029-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Lemonitsa Mammatas, PhD
PRINCIPAL INVESTIGATOR
Reinier De Graaf Ziekenhuis
Frequently Asked Questions
Who can join the NCT06106529 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06106529 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 260 participants.
Is NCT06106529 currently recruiting?
Yes, NCT06106529 is actively recruiting participants. Contact the research team at marte.smits@rdgg.nl for enrollment information.
Where is the NCT06106529 trial being conducted?
This trial is being conducted at Delft, Netherlands.
Who is sponsoring the NCT06106529 clinical trial?
NCT06106529 is sponsored by Reinier de Graaf Groep. The principal investigator is Lemonitsa Mammatas, PhD at Reinier De Graaf Ziekenhuis. The trial plans to enroll 260 participants.
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