Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart (BRAVEHeart)

July 25, 2023 updated by: University of Sydney

BRAVEHeart - Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart

This study investigates the Breathe Well device to test whether it is superior to the existing treatment standard of the Varian Realtime Position Management (RPM) system in assisting patients with deep inspiration breath hold.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Recent studies have demonstrated an increased risks of cardiac disease in breast cancer radiotherapy patients. For patients diagnosed <50 years old, the risks for cardiovascular diseases/events were increased by 24-82% comparing left and right breast radiotherapy. The deep inspiration breath hold (DIBH) technique addresses this problem by reducing the heart dose by up to half, thus potentially reducing the increased rate of major coronary events by 20%. Providing patients with visual feedback in addition to audio guidance has been demonstrated to improve the reproducibility of the DIBH technique by 95% and stability by 80%.

Breathe Well is a new audiovisual feedback device that may increase the accuracy and workflow of implementing DIBH for breast cancer patients.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Australia
    • New South Wales
      • St Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Left-sided breast cancer patients (invasive and in situ)
  • Supine positioning of the patients.
  • Ability to perform a ≥20s breath hold
  • >18 years old
  • An ECOG score in the range of 0 to 2
  • Able to give written informed consent and willingness to participate and comply with the study
  • Patients must be able to read and complete questionnaires in English

Exclusion Criteria:

  • Involvement or at risk regional lymph nodes
  • Pregnant / lactating women

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Breathe Well + RPM
Participants will receive Breathe Well audiovisual feedback in addition to the RPM system
Device: Breathe Well
Breathe Well is an audiovisual biofeedback device used to assist patients to regulate their breathing whilst undergoing radiation treatment.
Device: RPM
Varian Real-time Position Management (RPM) system
Active Comparator: RPM
Varian's RPM system is the current standard of care at Royal North Shore Hospital where this trial is to be run.
Device: RPM
Varian Real-time Position Management (RPM) system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of Breathe Well
Time Frame: 2 years
The accuracy will be measured by comparing 'Breathe Well' and RPM measurements with images acquired of the breast during the radiation treatment using an electronic portal imaging device (EPID).
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in set up times for Breathe Well vs RPM
Time Frame: 2 years
The setup times for both systems, the 'Breathe Well' and the modified RPM system; will be measured for all fractions.
2 years
Patient comfort
Time Frame: 2 years
To investigate patient comfort in using 'Breathe Well' via a patient survey.
2 years
Staff perception of Breathe Well
Time Frame: 2 years
To investigate staff perception of 'Breathe Well' via a technology assessment survey.
2 years
To develop the use of EPID for real time MLC tracking during breast radiotherapy
Time Frame: 2 years
2 years
To compare actual and planned doses
Time Frame: 2 years
Using dose reconstruction estimate the dose distribution delivered during radiotherapy and compare this with the planned dose.
2 years

Collaborators and Investigators

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

Sponsor

University of Sydney

Investigators

  • Principal Investigator: Gillian Lamoury, Medicine, Royal North Shore Hospital

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)

September 15, 2018

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

August 22, 2016

First Submitted That Met QC Criteria

August 22, 2016

First Posted (Estimated)

August 26, 2016

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 25, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRAVEHeartV1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymised data will be made available to researchers upon request, once evidence of ethical approval has been provided.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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