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

Carcinoma

Carcinoma in Situ

Respiratory Aspiration

Breast Carcinoma In Situ

Carcinoma, Intraductal, Noninfiltrating

Carcinoma, Ductal, Breast

Respiration Disorders

Respiratory Tract Diseases

Patients attend a simulation visit and undergo two CT scans, one in the prone position and one in the supine position with DIBH. Within 1 week after the simulation visit, patients undergo radiation therapy either in the supine position with DIBH or in the prone position daily for 15-30 consecutive days as per physician's prescription.

Undergo RT either in the supine position with DIBH or in the prone position.

Radiation Therapy (RT)

Naamit Gerber, MD

This phase II trial studies how well deep inspiratory breath hold or prone breast radiation therapy works in reducing cardiac dose in patients with breast cancer or ductal carcinoma in situ. Deep inspiratory breath hold is a technique that involves a patient holding their breath during radiation to move the heart away from the breast to minimize radiation to the heart. Prone breast radiation therapy is a technique in which a patient receives treatment "face-down" to minimize the radiation to the rest of the body, including the heart and lungs. Comparing deep inspiratory breath hold to prone breast radiation therapy may help doctors improve radiation to the target while reducing radiation to healthy tissues surrounding the target.

Patients attend a simulation visit and undergo two CT scans, one in the prone position and one in the supine position with DIBH. Within 1 week after the simulation visit, patients undergo radiation therapy either in the supine position with DIBH or in the prone position daily for 15-30 consecutive days as per physician's prescription

A Prospective Trial to Compare Deep Inspiratory Breath Hold (DIBH) With Prone Breast Irradiation

Assess whether the mean cardiac dose in the supine DIBH plan differs from the mean cardiac dose in the prone plan within strata defined by total RT dose.

The volume of heart receiving \>20Gy in DIBH plan vs. prone plan

The mean LAD dose in DIBH plan vs. prone plan

The maximum LAD dose in DIBH plan vs. prone plan

The mean ipsilateral lung dose in DIBH plan vs. prone plan

The volume of ipsilateral lung receiving \>20Gy in DIBH plan vs. prone plan

The volume of the contralateral breast receiving \>5Gy in DIBH plan vs. prone plan

The maximum point dose to PTV breast in DIBH plan vs. prone plan

The maximum separation in DIBH plan vs. prone plan

Distance from the mid-sternum to the nipple when the patient is in the prone position

PTV breast volume as calculated on the prone scan

The change in distance between the chest wall and heart (at the most lateral portion of the chestwall-heart interface) between the free breathing scout films and the DIBH scout films

Will be described by proportions and frequency distributions. Logistic regression will be used to assess how each of the covariates (primary and secondary endpoints) affects the probability of being selected to undergo RT using the supine DIBH plan. ROC curves will be generated for various cut-points of the true proportion of patients requiring the supine DIBH plan.

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
A Prospective Trial to Compare Deep Inspiratory Breath Hold (DIBH) With Prone Breast Irradiation	NCT03437161	Breast Cancer	Radiation Thera...	18 Years -	NYU Langone Health
A Prospective Trial to Compare Deep Inspiratory Breath Hold (DIBH) With Prone Breast Irradiation	NCT03437161	Breast Cancer	Radiation Thera...	18 Years -	NYU Langone Health

Spots Global Cancer Trial Database for dibh

Every month we try and update this database with for dibh cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for dibh

Every month we try and update this database with for dibh cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for dibh cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.