Clinical trial · Interventional
Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart
BRAVEHeart - Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart
NCT02881203CI-TRIAL-00068287BRAVEHeartcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breathe Well | Device | — | UNRESOLVED |
| RPM | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Breathe Well + RPM
- description
- Participants will receive Breathe Well audiovisual feedback in addition to the RPM system
- interventionNames
- Device: Breathe Well
- Device: RPM
- type
- ACTIVE_COMPARATOR
- label
- RPM
- description
- Varian's RPM system is the current standard of care at Royal North Shore Hospital where this trial is to be run.
- interventionNames
- Device: RPM
Primary outcomes (1)
- measure
- Accuracy of Breathe Well
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDByrne 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. PMID 36814310