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

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: Breast Cancer
• Intervention / Treatment: Device: Breathe Well; Device: RPM

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	The setup times for both systems, the 'Breathe Well' and the modified RPM system; will be measured for all fractions.	2 years
Patient comfort	To investigate patient comfort in using 'Breathe Well' via a patient survey.	2 years
Staff perception of Breathe Well	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		2 years
To compare actual and planned doses	Using dose reconstruction estimate the dose distribution delivered during radiotherapy and compare this with the planned dose.	2 years

Collaborators and Investigators

• Sponsor: University of Sydney
• Investigators: Principal Investigator: Gillian Lamoury, Medicine, Royal North Shore Hospital

Study record dates

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: breast cancer; radiation; cardiac toxicity; DIBH
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• 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