Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart

  • STATUS
    Recruiting
  • participants needed
    40
  • sponsor
    University of Sydney
Updated on 8 November 2020
Investigator
Elisabeth Steiner, PhD
Primary Contact
Gillian Lamoury (4.8 mi away) Contact

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.

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 2482% 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.

Details
Treatment Breathe Well, RPM
Clinical Study IdentifierNCT02881203
SponsorUniversity of Sydney
Last Modified on8 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you female?
Do you have Breast Cancer?
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
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