REDucing Hot FLASHes in Women Using Endocrine Therapy.

Phase 3RecruitingNCT06106529

Reinier de Graaf Groep260 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

260

Conditions

Breast Cancer Hot Flash Due to Medication

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number and severity of hot flashes

Number and severity of hot flashes during 6-weeks of therapy measured by the Hot Flash Diary.

Time frame: 15 weeks total

Secondary Outcomes

Quality of life and health status

Quality of life and health status at baseline and after 6 weeks of treatment measured by the EORTC-QLQ-C30

Time frame: 15 weeks total

Adverse effects of treatments

Adverse effects of treatments weekly measured by the National Cancer Institute Common Toxicity Criteria scale, version 5

Time frame: 15 weeks total

Sleep quality

Sleep quality at baseline and after 6 weeks of treatment measured by the Groningen Sleep Quality Scale (GSQ)

Time frame: 15 weeks total

Anxiety and depression

Anxiety and depression measured at baseline and after 6 weeks of treatment with the Hospital Anxiety and Depression Scale (HADS)

Time frame: 15 weeks total

Sexual function

Sexual function measured at baseline and after 6 weeks of treatment with the Sexual Activity Questionnaire (SAQ)

Time frame: 15 weeks total

Cognitive function

Cognitive function measured at baseline and after 6 weeks of treatment with the 6-item cognitive impairment test (6-CIT)

Time frame: 15 weeks total

Adherence

Ask patients the following question after 6 weeks of treatment: 'Would you like to continue the endocrine therapy for the recommended duration of therapy taking the current medication (oxybutynin or venlafaxine) given the number and severity of hot flashes you experience during the last week?'

Time frame: 15 weeks total

Preference

Ask patients the following question after 6 weeks of the final treatment: 'Do you have a preference taking the medication from study period 1 or study period 2?'

Time frame: 15 weeks total

REDucing Hot FLASHes in Women Using Endocrine Therapy.

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts