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Completed

NCT Number: NCT02881203

Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Heart Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breathe Well

Device

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

RPM

Device

Varian Real-time Position Management (RPM) system

Primary outcomes

  1. Accuracy of Breathe Well

    Time frame: 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 outcomes

  1. Difference in set up times for Breathe Well vs RPM

    Time frame: 2 years

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

  2. Patient comfort

    Time frame: 2 years

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

  3. Staff perception of Breathe Well

    Time frame: 2 years

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

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

    Time frame: 2 years

  5. To compare actual and planned doses

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

University of Sydney

Other

Registry information

Official study title

BRAVEHeart - Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart

Acronym: BRAVEHeart

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Aug 26, 2016
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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