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Trial Title:
REDucing Hot FLASHes in Women Using Endocrine Therapy.
NCT ID:
NCT06106529
Condition:
Breast Cancer
Hot Flash Due to Medication
Conditions: Official terms:
Breast Neoplasms
Hot Flashes
Venlafaxine Hydrochloride
Oxybutynin
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Oxybutynin
Description:
Oxybutynin 5 mg twice per day for 6 weeks
Arm group label:
Oxybutynin
Arm group label:
Venlafaxine
Intervention type:
Drug
Intervention name:
Venlafaxine
Description:
Venlafaxine 37.5 mg once daily for 7 days followed by 75 mg once daily for 5 weeks
Arm group label:
Oxybutynin
Arm group label:
Venlafaxine
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
June 15, 2024
Completion date:
January 1, 2029
Lead sponsor:
Agency:
Reinier de Graaf Groep
Agency class:
Other
Source:
Reinier de Graaf Groep
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06106529
