Breast Cancer
Conditions
Keywords
breast cancer, radiation, DIBH, cardiac toxicity
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.
Interventions
DEVICEBreathe Well
Breathe Well is an audiovisual biofeedback device used to assist patients to regulate their breathing whilst undergoing radiation treatment.
DEVICERPM
Varian Real-time Position Management (RPM) system
Sponsors
University of Sydney
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Patient comfort | 2 years | To investigate patient comfort in using 'Breathe Well' via a patient survey. |
| Staff perception of Breathe Well | 2 years | To investigate staff perception of 'Breathe Well' via a technology assessment 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. |
Countries
Australia
Outcome results
None listed