Actively Recruiting
REDucing Hot FLASHes in Women Using Endocrine Therapy.
Led by Reinier de Graaf Groep · Updated on 2025-02-04
260
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
REDucing Hot FLASHes in Women Using Endocrine Therapy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 years or older, including pre-, peri-, or postmenopausal
- Currently on endocrine therapy with tamoxifen, aromatase inhibitors, or luteinizing hormone-releasing hormone analogues for at least 4 weeks and planning to continue during the study
- Experiencing at least 14 hot flashes per week for at least 1 month and interested in starting medication for hot flashes
You will not qualify if you...
- Pregnant or breastfeeding
- Received chemotherapy, immunotherapy, or HER2 antibodies within the past 8 weeks, or scheduled for chemotherapy during the study
- In a palliative care setting
- Use of venlafaxine, oxybutynin, other antidepressants, or St. John's wort within the past year
- Creatinine clearance less than 30 ml/min
- Liver cirrhosis
- Use of gabapentin or calcium channel blockers within 2 weeks before study start
- Use of any other treatments for hot flashes such as acupuncture
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Reinier de Graaf Gasthuis
Delft, South Holland, Netherlands, 2625 AD
Actively Recruiting
Research Team
M
Marte Smits, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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