跳至主要内容
临床试验/NCT04986293
NCT04986293招募中不适用

Continuous and Bi-level Positive Airway Pressure for Motion Mitigation of Intra-thoracic Tumors Treated With Radiotherapy

University Medical Center Groningen2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
31
试验地点
2
主要终点
Lung volume changes induced by the use of mechanical ventilation

研究概览

简要总结

When using highly conformal radiotherapy techniques, such as proton therapy, a controlled breathing pattern and a minimal breathing amplitude could greatly benefit the treatment of mobile tumors. This reduction in tumor motion may be achieved with the use of a ventilator that is able to regulate and modulate the breathing pattern. CPAP provides a constant level of positive airway pressure. Compared to spontaneous breathing, the use of CPAP increased lung volume and can result in a significant decrease in tumor movement and a significant decrease in both mean lung and mean heart radiation dose. These results were found in patients treated for limited stage disease, it is not clear if this approach is feasible for patients with more advanced stage of disease that undergo radiotherapy with curative intent.

With Bilevel Positive Airway Pressure (BiPAP), tidal volume excursions are determined by the pressure difference between the set inspiratory positive airway pressure (IPAP) and the set expiratory positive airway pressure (EPAP). This mode of ventilation increases lung volume comparable to CPAP, but also to control tidal volumes and breathing frequency. However, BiPAP has never been studied in the setting of motion mitigation during radiotherapy and BiPAP might be more difficult to adjust to for patients compared to CPAP. Therefore, the current study is proposed to evaluate whether or not CPAP or BiPAP is of benefit in patients that undergo radiotherapy for larger intra-thoracic tumor volumes.

详细描述

The study will follow a 2-step approach.

First (Phase 1, n=10), the feasibility of short-term use of CPAP and BiPAP and its effects on (regional) lung volumes, tidal volumes and breathing frequency will be investigated in patients with intra-thoracic tumors who are planned for radiotherapy. This is necessary to select the best setting of CPAP or BiPAP with which minimal tumor motion is expected (and that is feasible for the patient).

In the second phase (n=21), the particular setting found in fase 1 is investigated: weekly repeated radiotherapy planning (4D) CT scans with and without CPAP/BiPAP will be aquired to evaluate the influence on tumor motion and dose to the target and organs at risk. Radiotherapy will be deliverd according to local protocol without the use of CPAP/BiPAP.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

入选标准

  • Age ≥18 years
  • Stage III/IV (N)SCLC, esophageal cancer or malignant lymphoma that will be treated with curative intent
  • Written informed consent

排除标准

  • Facial deformations so that facial mask is impossible to fit
  • Noncompliance with any of the inclusion criteria.
  • Planned for radiotherapy with fraction dose ≥3 Gy.
  • Severe heart failure (LVEF<30%)

结局指标

主要结局

Lung volume changes induced by the use of mechanical ventilation

时间窗: 2-3 hours of measurement (only once)

The primary objective is to evaluate the lung volume changes (in cm3) induced by the use of mechanical ventilation

次要结局

  • Feasibility of mechanical ventilation(once every week up to a maximum of 5 consecutive weeks (depending on the duration of the course of radiotherapy))

研究者

申办方类型
Other
责任方
Sponsor
主要研究者

R. Wijsman

Principal Investigator

University Medical Center Groningen

研究点 (2)

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