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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart
Scientific title
BRAVEHeart - Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0

Study type
Description of intervention(s) / exposure
Treatment: Devices - Breathe Well
Treatment: Devices - RPM

Experimental: Breathe Well + RPM - Participants will receive Breathe Well audiovisual feedback in addition to the 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.

Treatment: Devices: Breathe Well
Breathe Well is an audiovisual biofeedback device used to assist patients to regulate their breathing whilst undergoing radiation treatment.

Treatment: Devices: RPM
Varian Real-time Position Management (RPM) system

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Patient comfort - To investigate patient comfort in using 'Breathe Well' via a patient survey.
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Staff perception of Breathe Well - To investigate staff perception of 'Breathe Well' via a technology assessment survey.
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
To develop the use of EPID for real time MLC tracking during breast radiotherapy
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
To compare actual and planned doses - Using dose reconstruction estimate the dose distribution delivered during radiotherapy and compare this with the planned dose.
Timepoint [5] 0 0
2 years

Key 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
Minimum age
18 Years
Maximum age
No limit
Can healthy volunteers participate?
Key exclusion criteria
- Involvement or at risk regional lymph nodes

- Pregnant / lactating women

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 0 0
2065 - St Leonards

Funding & Sponsors
Primary sponsor type
University of Sydney

Ethics approval
Ethics application status

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Gillian Lamoury, Medicine
Address 0 0
Royal North Shore Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.