Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart

University of Sydney45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Breathe WellDEVICE

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

RPMDEVICE

Varian Real-time Position Management (RPM) system

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Outcomes

Primary Outcomes

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).

Time frame: 2 years

Secondary Outcomes

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.

Time frame: 2 years

Patient comfort

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

Time frame: 2 years

Staff perception of Breathe Well

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

Time frame: 2 years

To develop the use of EPID for real time MLC tracking during breast radiotherapy

Time frame: 2 years

To compare actual and planned doses

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

Time frame: 2 years

Data from ClinicalTrials.gov

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