Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Device: Breathe Well; Device: RPM

• Registration Number: NCT02881203
• Lead Sponsor: University of Sydney

Brief 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.

Study Timeline

• Study First Submitted: 2016-08-22
• Study First Submitted QC: 2016-08-22
• Study First Posted: 2016-08-26
• Study Start: 2018-09-15
• Primary Completion: 2021-09-30
• Study Completion: 2022-09-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-25
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

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

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Exclusion Criteria

• Involvement or at risk regional lymph nodes
• Pregnant / lactating women

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breathe Well + RPM	Breathe Well	Participants will receive Breathe Well audiovisual feedback in addition to the RPM system
Breathe Well + RPM	RPM	Participants will receive Breathe Well audiovisual feedback in addition to the RPM system
RPM	RPM	Varian's RPM system is the current standard of care at Royal North Shore Hospital where this trial is to be run.

Primary Outcome Measures

Name	Time	Method
Accuracy of Breathe Well	2 years	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).

Secondary Outcome Measures

Name	Time	Method
Patient comfort	2 years	To investigate patient comfort in using 'Breathe Well' via a patient survey.
To develop the use of EPID for real time MLC tracking during breast radiotherapy	2 years
To compare actual and planned doses	2 years	Using dose reconstruction estimate the dose distribution delivered during radiotherapy and compare this with the planned dose.
Difference in set up times for Breathe Well vs RPM	2 years	The setup times for both systems, the 'Breathe Well' and the modified RPM system; will be measured for all fractions.
Staff perception of Breathe Well	2 years	To investigate staff perception of 'Breathe Well' via a technology assessment survey.

Trial Locations

Locations (1)

Royal North Shore Hospital; 🇦🇺 St Leonards, New South Wales, Australia