Breast CancerBRAVEHeartNCT02881203
Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart
A study testing Breathe Well and RPM in people with Breast Cancer, run by University of Sydney at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Breathe Well and RPM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Sep 2018to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Involvement or at risk regional lymph nodes
- Pregnant / lactating women
Trial locations and contacts
1 site in 1 country.
Australia1 site
Royal North Shore Hospital
St Leonards, New South Wales, 2065
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Breathe Well, RPM
- Keywords
- breast cancer, radiation, DIBH, cardiac toxicity
- Medical subject headings
- Breast Neoplasms, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathe WellDevice
Breathe Well is an audiovisual biofeedback device used to assist patients to regulate their breathing whilst undergoing radiation treatment.
RPMDevice
Varian Real-time Position Management (RPM) system
| Study group | Role | What they receive |
|---|---|---|
| Breathe Well + RPM | Experimental | Participants will receive Breathe Well audiovisual feedback in addition to the RPM system Receives: Device: Breathe Well; Device: RPM |
| RPM | Active comparator | Varian's RPM system is the current standard of care at Royal North Shore Hospital where this trial is to be run. Receives: Device: RPM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 years
Secondary outcomes (5)
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.
Measured: 2 years
Patient comfort
To investigate patient comfort in using 'Breathe Well' via a patient survey.
Measured: 2 years
Staff perception of Breathe Well
To investigate staff perception of 'Breathe Well' via a technology assessment survey.
Measured: 2 years
To develop the use of EPID for real time MLC tracking during breast radiotherapy
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study start15 Sep 2018
- Primary completion30 Sep 2021
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gillian Lamoury, Medicine, Principal investigator, Royal North Shore Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881203
- Sponsor's protocol ID
- BRAVEHeartV1
- Acronym
- BRAVEHeart
- Status last verified
- Jul 2023
- First submitted
- 22 Aug 2016
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data will be made available to researchers upon request, once evidence of ethical approval has been provided.
Publications
Byrne HL, Steiner E, Booth J, Lamoury G, Morgia M, Richardson K, Ambrose L, Makhija K, Stanton C, Zwan B, Bromley R, Atyeo J, Silvester S, Plant N, Keall P. BRAVEHeart: a randomised trial comparing the accuracy of Breathe Well and RPM for deep inspiration breath hold breast cancer radiotherapy. Trials. 2023 Feb 22;24(1):132. doi: 10.1186/s13063-023-07072-y.
PubMed 36814310
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRAVEHeart - Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart
- ClinicalTrials.gov ID
- NCT02881203
- Acronym / sponsor ID
- BRAVEHeart / BRAVEHeartV1
- Conditions
- Breast Cancer
- Keywords
- breast cancer, radiation, DIBH, cardiac toxicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 26 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breathe Well + RPM | Experimental | Device: Breathe Well, Device: RPMParticipants will receive Breathe Well audiovisual feedback in addition to the RPM system |
| RPM | Active comparator | Device: RPMVarian's RPM system is the current standard of care at Royal North Shore Hospital where this trial is to be run. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Involvement or at risk regional lymph nodes
- Pregnant / lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathe WellBreathe Well is an audiovisual biofeedback device used to assist patients to regulate their breathing whilst undergoing radiation treatment. | Device | Breathe Well + RPM |
| RPMVarian Real-time Position Management (RPM) system | Device | Breathe Well + RPM, RPM |
Primary outcome
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).
5 secondary outcomes
Difference in set up times for Breathe Well vs RPM
Time frame: 2 years
Patient comfort
Time frame: 2 years
Staff perception of Breathe Well
Time frame: 2 years
To develop the use of EPID for real time MLC tracking during breast radiotherapy
Time frame: 2 years
To compare actual and planned doses
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Derived from this study: PubMed 36814310Byrne HL, Steiner E, Booth J, Lamoury G, Morgia M, Richardson K, Ambrose L, Makhija K, Stanton C, Zwan B, Bromley R, Atyeo J, Silvester S, Plant N, Keall P. BRAVEHeart: a randomised trial comparing the accuracy of Breathe Well and RPM for deep inspiration breath hold breast cancer radiotherapy. Trials. 2023 Feb 22;24(1):132. doi: 10.1186/s13063-023-07072-y.
- Individual participant dataSharing planned: Yes. Anonymised data will be made available to researchers upon request, once evidence of ethical approval has been provided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gillian Lamoury, Medicine principal investigator
Royal North Shore Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathe Well and RPM in people with Breast Cancer, run by University of Sydney at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Breathe Well (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02881203, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.