NCT02881203

Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart

BRAVEHeart - Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University of Sydney · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

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

Timeline

• Start date: 2018-09-15
• Primary completion: 2021-09-30
• Completion: 2022-09-30
• First posted: 2016-08-26
• Last updated: 2023-07-27

Locations

1 site across 1 country: Australia