A Prospective Study to Evaluate Continuous Positive Airway Pressure Devices to Reduce Pulmonary Dose
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Dosimetry comparison CPAP and free breathing.
研究概览
简要总结
Data collection and assessment on patients with left-sided breast cancer or undergoing lung stereotactic body radiation therapy (SBRT) utilizing continuous positive airway pressure (CPAP) devices.
详细描述
Lung stereotactic body radiation therapy (SBRT) has emerged as a definitive treatment for patients with early-stage lung cancers as well as for patients with limited metastases to the lung. One challenge with the treatment of the lung is the risk of pulmonary toxicity, particularly for early-stage lungs cancers that are inoperable (those receiving primary lung SBRT) or those with metastatic cancers receiving systemic therapy that may impact pulmonary function (those receiving lung SBRT for metastatic cancers).
Continuous positive airway pressure (CPAP) devices are commonly utilized for patients with obstructive sleep apnea. However, through the use of continuous pressure, lung volumes are increased. Preliminary data in patients undergoing breast radiation as well as lung radiation has demonstrated the safety and feasibility of such an approach, demonstrating increased lung volumes with decreases in heart dose6-8. Additional potential advantages of CPAP include increased ease of use for patients and the potential for cost savings as compared to traditional respiratory management techniques.
This prospective study is to allow for the collection and assessment of data on patients with left-sided breast cancer or undergoing lung SBRT utilizing CPAP. This will allow for the assessment of lung doses with and without CPAP as well as cardiac doses. No additional changes to our standard of care breast or lung radiation will occur. With respect to the safety profile, CPAP is commonly used with limited toxicity concerns. The potential benefit of CPAP has reduced lung and heart doses and, consequently, radiation-related toxicities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with left-sided breast cancers
- •Patients must be undergoing left breast/chest wall radiation with or without regional nodal irradiation
- •Patients undergoing lung SBRT
- •Primary lung cancers
- •Metastatic lung tumors
排除标准
- •Patients with right side breast cancer
- •Patients who are unable to tolerate the CPAP device
研究组 & 干预措施
Lung SBRT
Participants will come in for their regularly scheduled radiation planning and treatment. Participants will undergo three scans (with and without DIBH (i.e., free-breathing), with CPAP). Participants will also use the CPAP device before the CT scan, for which they will be educated and trained.
干预措施: Free Breath (Other)
left-sided breast cancer
Participants will come in for their regularly scheduled radiation planning and treatment. Participants will undergo three scans (with and without DIBH (i.e., free-breathing), with CPAP). Participants will also use the CPAP device before the CT scan, for which they will be educated and trained.
干预措施: Continuous Positive Airway Pressure (Device)
left-sided breast cancer
Participants will come in for their regularly scheduled radiation planning and treatment. Participants will undergo three scans (with and without DIBH (i.e., free-breathing), with CPAP). Participants will also use the CPAP device before the CT scan, for which they will be educated and trained.
干预措施: Deep inspiratory breath hold (Other)
left-sided breast cancer
Participants will come in for their regularly scheduled radiation planning and treatment. Participants will undergo three scans (with and without DIBH (i.e., free-breathing), with CPAP). Participants will also use the CPAP device before the CT scan, for which they will be educated and trained.
干预措施: Free Breath (Other)
Lung SBRT
Participants will come in for their regularly scheduled radiation planning and treatment. Participants will undergo three scans (with and without DIBH (i.e., free-breathing), with CPAP). Participants will also use the CPAP device before the CT scan, for which they will be educated and trained.
干预措施: Continuous Positive Airway Pressure (Device)
Lung SBRT
Participants will come in for their regularly scheduled radiation planning and treatment. Participants will undergo three scans (with and without DIBH (i.e., free-breathing), with CPAP). Participants will also use the CPAP device before the CT scan, for which they will be educated and trained.
干预措施: Deep inspiratory breath hold (Other)
结局指标
主要结局
Dosimetry comparison CPAP and free breathing.
时间窗: At the time of Scan, " Day 1"
The primary objective will be to assess changes in lung dosimetry V5 on the affected side when using CPAP compared to free breathing will be measured in percentages.
次要结局
- Total Lung dosimetry(At the time of Scan, " Day 1")
- Cardiac dosimetry with CPAP as compared to free breathing(At the time of Scan, " Day 1")
- Treatment time with CPAP treatments(At the time of Scan, " Day 1")
- Measure breast/chest wall or lung tumor motion as well as organ at risk motion(At the time of Scan, " Day 1")
- Confirm maintenance of inflation with CPAP using surface guidance(At the time of Scan, " Day 1")