Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart

NCT02881203 | Completed

• 1 other identifier: BRAVEHeartV1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer; radiation; DIBH; cardiac toxicity

Outcome Measures

Primary Outcomes (1)

• 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).

  2 years

Secondary Outcomes (5)

• Difference in set up times for Breathe Well vs RPM

  2 years

• Patient comfort

  2 years

• Staff perception of Breathe Well

  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

Study Arms (2)

Breathe Well + RPM

EXPERIMENTAL

Participants will receive Breathe Well audiovisual feedback in addition to the RPM system

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.

Device: RPM

Interventions

Breathe Well DEVICE

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

Breathe Well + RPM

RPM DEVICE

Varian Real-time Position Management (RPM) system

Breathe Well + RPM; RPM

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Involvement or at risk regional lymph nodes
• Pregnant / lactating women

Sponsors & Collaborators

• University of Sydney: lead

Study Sites (1)

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Related Publications (1)

• 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.

  PMID: 36814310 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Cardiotoxicity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• Gillian Lamoury, Medicine

  Royal North Shore Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: August 26, 2016
• Study Start: September 15, 2018
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2022
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)