BRAVEHeart - Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Sydney
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Accuracy of Breathe Well
Study Overview
Brief Summary
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
RPM
Varian's RPM system is the current standard of care at Royal North Shore Hospital where this trial is to be run.
Intervention: RPM (Device)
Breathe Well + RPM
Participants will receive Breathe Well audiovisual feedback in addition to the RPM system
Intervention: Breathe Well (Device)
Breathe Well + RPM
Participants will receive Breathe Well audiovisual feedback in addition to the RPM system
Intervention: RPM (Device)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Patient comfort(2 years)
- To develop the use of EPID for real time MLC tracking during breast radiotherapy(2 years)
- To compare actual and planned doses(2 years)
- Difference in set up times for Breathe Well vs RPM(2 years)
- Staff perception of Breathe Well(2 years)