Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Heart and Blood Diseases

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Breast Neoplasms

Cardiotoxicity

Breast Diseases

Skin Diseases

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

Varian's RPM system is the current standard of care at Royal North Shore Hospital where this trial is to be run.

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

Breathe Well

Varian Real-time Position Management (RPM) system

Gillian Lamoury, Medicine

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.

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.

Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart

BRAVEHeart - Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart

Anonymised data will be made available to researchers upon request, once evidence of ethical approval has been provided.

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).

The setup times for both systems, the 'Breathe Well' and the modified RPM system; will be measured for all fractions.

To investigate patient comfort in using 'Breathe Well' via a patient survey.

To investigate staff perception of 'Breathe Well' via a technology assessment survey.

Using dose reconstruction estimate the dose distribution delivered during radiotherapy and compare this with the planned dose.

University of Sydney

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Lung Neoplasms

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

All Drugs and Chemicals

Liver Extracts

Investigation of respiratory-related tumour motion in liver cancer patients undergoing stereotactic body radiotherapy treatment (SBRT) using audiovisual (AV) biofeedback.

Investigation of Respiratory-related Tumour Motion in Liver Cancer Patients Undergoing SBRT Using Audiovisual Biofeedback

Investigation of Respiratory-related Tumour Motion in Liver Cancer Patients Undergoing Stereotactic Body Radiotherapy Treatment (SBRT) Using Audiovisual (AV) Biofeedback

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart	NCT02881203	Breast Cancer	Breathe Well RPM	18 Years -	University of Sydney
Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart	NCT02881203	Breast Cancer	Breathe Well RPM	18 Years -	University of Sydney
Investigation of Respiratory-related Tumour Motion in Liver Cancer Patients Undergoing SBRT Using Audiovisual Biofeedback	NCT04323618	Lung Cancer	Breathe Well	18 Years -	University of Sydney

Spots Global Cancer Trial Database for breathe well

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