NCT06037902招募中不适用
Use of CPAP (Continuous Positive Airway Pressure) for Simulating Esophageal Cancer Patients Prior to Radiotherapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- absolute mean heart radiation dose
研究概览
简要总结
The goal of this clinical trial is to test the use of CPAP in patients with esophgaeal cancer undergoing radiotherapy.
The main questions it aims to answer are:
- does use of CPAP decrease exposure of normal lung to radiation?
- does use of CPAP decrease exposure of normal heart to radiation?
Participants will undergo simulation twice:
- with CPAP
- without CPAP
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Diagnosis of cancer, with a tumor (primary or secondary) in the esophagus including tumors in the esophagus-stomach junction.
- •Planned RT treatment
- •The level of functioning ≥ 60 on the Karnofsky scale
- •Life expectancy ≥ two months
- •All patients must understand the informed consent form document and sign it of their own free will before any test/procedure related to the study is performed.
- •Able to undergo simulation and radiation with CPAP
- •Candidate patients can be recruited to receive definitive, palliative or pre-operative radiation, with or without chemotherapy.
排除标准
- •A person who meets any of the following exclusion criteria will not be able to participate in the study:
- •Pregnancy or breastfeeding
- •Significant comorbidity at the starting point that would prevent the use of CPAP
- •Hospitalized in an institution by virtue of an administrative order or a court order.
- •Special population
- •A history of a psychiatric problem that may impair the patient's ability to understand the research requirements or respond to them, or to give his consent
结局指标
主要结局
absolute mean heart radiation dose
时间窗: on day of simulation (day 1)
measured in Gy
次要结局
- heart dose in Gy(on day of simulation (day 1))
- lung dose in Gy(on day of simulation (day 1))
- movement of tumor in cm(on day of simulation (day 1))
研究者
Dr. Yaacov Lawrence
Chair of Department of Radiation Oncology, principal investigator
Sheba Medical Center
研究点 (2)
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