REDucing Hot FLASHes in Women Using Endocrine Therapy. (REDFLASH)

January 31, 2025 updated by: Reinier de Graaf Groep

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.

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
260

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Netherlands
    • Zuid-Holland
      • Delft, Zuid-Holland, Netherlands, 2625 AD
        • Recruiting
        • Reinier de Graaf Gasthuis
        • Contact:
        • Contact:
          • Marte Smits, MSc
        • Contact:
          • Lemonitsa Mammatas, PHD, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Venlafaxine

In this open-label randomized controlled intrapatient cross-over study patients are randomly assigned to one of the two treatment groups.

After a one week baseline period, group 1 starts with venlafaxine 37.5 mg once daily for 7 days followed by 75 mg once daily for 5 weeks followed by a two-week wash-out period (no medication), hereafter the group starts with oxybutynin 5 mg twice per day for 6 weeks total.
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
Experimental: Oxybutynin
After a one week baseline period, group 2 starts with oxybutynin 5 mg twice per day for 6 weeks total followed by a two-week wash-out period (no medication), hereafter the group starts with venlafaxine 37.5 mg once daily for 7 days followed by 75mg once daily for 5 weeks.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number and severity of hot flashes
Time Frame: 15 weeks total
Number and severity of hot flashes during 6-weeks of therapy measured by the Hot Flash Diary.
15 weeks total

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of life and health status
Time Frame: 15 weeks total
Quality of life and health status at baseline and after 6 weeks of treatment measured by the EORTC-QLQ-C30
15 weeks total
Adverse effects of treatments
Time Frame: 15 weeks total
Adverse effects of treatments weekly measured by the National Cancer Institute Common Toxicity Criteria scale, version 5
15 weeks total
Sleep quality
Time Frame: 15 weeks total
Sleep quality at baseline and after 6 weeks of treatment measured by the Groningen Sleep Quality Scale (GSQ)
15 weeks total
Anxiety and depression
Time Frame: 15 weeks total
Anxiety and depression measured at baseline and after 6 weeks of treatment with the Hospital Anxiety and Depression Scale (HADS)
15 weeks total
Sexual function
Time Frame: 15 weeks total
Sexual function measured at baseline and after 6 weeks of treatment with the Sexual Activity Questionnaire (SAQ)
15 weeks total
Cognitive function
Time Frame: 15 weeks total
Cognitive function measured at baseline and after 6 weeks of treatment with the 6-item cognitive impairment test (6-CIT)
15 weeks total
Adherence
Time Frame: 15 weeks total
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?'
15 weeks total
Preference
Time Frame: 15 weeks total
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?'
15 weeks total

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Reinier de Graaf Groep

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lemonitsa Mammatas, PhD, Reinier de Graaf Ziekenhuis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 3, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REDFLASH2023-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study protocol, anonymised database and study results may be available on request, after assessment of the reason for request by the study investigators.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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