Clinical trial NCT06106529: REDucing Hot FLASHes in Women Using Endocrine Therapy.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Hot Flash Due to Medication
Lead sponsor: Reinier de Graaf Groep
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 260
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Number and severity of hot flashes
timeFrame: 15 weeks total
Secondary outcomes:
measure: Quality of life and health status
timeFrame: 15 weeks total
measure: Adverse effects of treatments
timeFrame: 15 weeks total
measure: Sleep quality
timeFrame: 15 weeks total
measure: Anxiety and depression
timeFrame: 15 weeks total
measure: Sexual function
timeFrame: 15 weeks total
measure: Cognitive function
timeFrame: 15 weeks total
measure: Adherence
timeFrame: 15 weeks total
measure: Preference
timeFrame: 15 weeks total
Other outcomes:
Locations:
city: Delft
country: Netherlands
facility: Reinier de Graaf Gasthuis
state: Zuid-Holland
Study officials:
affiliation: Reinier De Graaf Ziekenhuis
name: Lemonitsa Mammatas, PhD
role: PRINCIPAL_INVESTIGATOR
References: