Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart

Breast Cancer Clinical Trial

— BRAVEHeart  

Official title:

BRAVEHeart - Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02881203
• Other study ID #: BRAVEHeartV1
• Status: Completed
• Phase: N/A
• Start date: September 15, 2018
• Est. completion date: September 30, 2022

Study information

• Verified date: July 2023
• Source: University of Sydney
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Breathe Well
Breathe Well is an audiovisual biofeedback device used to assist patients to regulate their breathing whilst undergoing radiation treatment.
• RPM
Varian Real-time Position Management (RPM) system

Locations

Country	Name	City	State
Australia	Royal North Shore Hospital	St Leonards	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
University of Sydney

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	2 years
Secondary	Patient comfort	To investigate patient comfort in using 'Breathe Well' via a patient survey.	2 years
Secondary	Staff perception of Breathe Well	To investigate staff perception of 'Breathe Well' via a technology assessment survey.	2 years
Secondary	To develop the use of EPID for real time MLC tracking during breast radiotherapy		2 years
Secondary	To compare actual and planned doses	Using dose reconstruction estimate the dose distribution delivered during radiotherapy and compare this with the planned dose.	2 years