BRAVEHeart - Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Accuracy of Breathe Well
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Involvement or at risk regional lymph nodes
- •Pregnant / lactating women
结局指标
主要结局
Accuracy of Breathe Well
时间窗: 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).
次要结局
- Patient comfort(2 years)
- To develop the use of EPID for real time MLC tracking during breast radiotherapy(2 years)
- To compare actual and planned doses(2 years)
- Difference in set up times for Breathe Well vs RPM(2 years)
- Staff perception of Breathe Well(2 years)