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Recruiting NCT06106529

REDucing Hot FLASHes in Women Using Endocrine Therapy.

Phase III Interventional Breast Cancer Hot Flash Due to Medication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oxybutynin, Venlafaxine.
Who it may be relevant to
Registry conditions: Breast Cancer, Hot Flash Due to Medication. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

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.

Interventions

  • Drug Oxybutynin
    Oxybutynin 5 mg twice per day for 6 weeks
  • Drug Venlafaxine
    Venlafaxine 37.5 mg once daily for 7 days followed by 75 mg once daily for 5 weeks

Primary outcome measures

  • Number and severity of hot flashes [Time frame: 15 weeks total]
Secondary outcome measures (8)
  • Quality of life and health status [Time frame: 15 weeks total]
  • Adverse effects of treatments [Time frame: 15 weeks total]
  • Sleep quality [Time frame: 15 weeks total]
  • Anxiety and depression [Time frame: 15 weeks total]
  • Sexual function [Time frame: 15 weeks total]
  • Cognitive function [Time frame: 15 weeks total]
  • Adherence [Time frame: 15 weeks total]
  • Preference [Time frame: 15 weeks total]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Netherlands · 1 center
  • Reinier de Graaf Gasthuis — Delft

Identifiers

NCT: NCT06106529 · REDFLASH2023-004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗