Reducing hot flashes in women undergoing endocrine therapy for breast cancer
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.
This study tests whether oxybutynin or venlafaxine can help women going through endocrine therapy for breast cancer reduce their hot flashes and feel better overall.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Reinier de Graaf Groep Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Delft, South Holland) |
| Trial ID | NCT06106529 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of oxybutynin and venlafaxine in alleviating hot flashes in women who are receiving endocrine therapy after breast cancer treatment. Participants will be randomly assigned to receive either medication and will maintain a daily diary for 15 weeks to track their symptoms and side effects. Additionally, they will complete online questionnaires to assess their personal preferences and quality of life related to the treatment. The study seeks to provide insights into which medication is more effective and better tolerated by patients.
Who should consider this trial
Good fit: Ideal candidates are pre-, peri-, or postmenopausal women aged 18 and older who are experiencing significant hot flashes while on endocrine therapy.
Not a fit: Patients who are pregnant, breastfeeding, or have recently undergone chemotherapy or immunotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for managing hot flashes in women undergoing endocrine therapy for breast cancer.
How similar studies have performed: Previous studies have shown varying degrees of success in using both oxybutynin and venlafaxine for managing hot flashes, but this specific comparative approach is less common.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Delft, South Holland
- Reinier de Graaf Gasthuis — Delft, South Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Lemonitsa Mammatas, PhD — Reinier De Graaf Ziekenhuis
- Study coordinator: Marte Smits, MSc
- Email: marte.smits@rdgg.nl
- Phone: +31152603870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.