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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02881203




Registration number
NCT02881203
Ethics application status
Date submitted
22/08/2016
Date registered
26/08/2016
Date last updated
19/05/2021

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
BRAVEHeartV1
Universal Trial Number (UTN)
Trial acronym
BRAVEHeart
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
Breast

Intervention/exposure
Study type
Interventional
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

Outcomes
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

Eligibility
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
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Involvement or at risk regional lymph nodes

- Pregnant / lactating women

Study design
Purpose of the study
Treatment
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Gillian Lamoury - St Leonards
Recruitment postcode(s) [1] 0 0
2065 - St Leonards

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country

Ethics approval
Ethics application status

Summary
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
https://clinicaltrials.gov/show/NCT02881203
Trial related presentations / publications
Public notes

Contacts
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
Elisabeth Steiner, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 2 86271185
Fax 0 0
Email 0 0
elisabeth.steiner@sydney.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02881203