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临床试验/NCT02324530
NCT02324530Unknown2 期

Evaluation of CPAP (Continuous Positive Airway Pressure) in the Planning of Radiation Treatments for Lung, Upper Abdomen and Left Breast Cancers

Sheba Medical Center2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
2 期
入组人数
30
试验地点
2
主要终点
Reduction in amplitude of tumor motion

研究概览

简要总结

This is a clinical study on patients to compare the effects of CPAP on lung volume diaphragm motion, heart position and tumor motion compared to free breathing. Only patients with significant tumor motion of greater than 1 cm amplitude or unfavorable chest wall geometry (heart close to chest wall) identified on standard imaging and simulation will be candidates for the study. Patients will be re- simulated and planned for radiation treatments with CPAP. The radiation plans generated with and without CPAP will be compared to evaluate the impact of CPAP on tumor motion and dose delivered to adjacent critical structures such as the heart and lung.

详细描述

Primary Objectives

  • Evaluate effectiveness of CPAP to reproducibly reduce tumor and organ motion during radiation therapy treatments.
  • Determine if CPAP allows for a reduction in normal tissue receiving radiation in chest and abdomen tumors and reduce heart exposure for patients receiving left breast irradiation.

Entry Criteria: This is a proof of concept and feasibility study. We propose to study 10 patients in each group for a total of thirty patients.

Eligibility criteria Group1. Lung tumors and nodules with tumor motion greater than 1 cm on standard imaging (n=10) Group2. Left sided breast tumors with unfavorable anatomy, viz heart abutting chest wall (n=10) Group3. Upper abdominal tumors: Liver and Pancreas with tumor motion greater than 1 cm. (n=10)

Pretreatment evaluations/management for patients meeting eligibility criteria CPAP All patients will be evaluated by a pulmonologist for their respiratory performances including physical examination, oxygen saturation and pulmonary function tests including DLCO that will serve for baseline measures. Then, adjustment session will be performed aiming to get adjusted to a CPAP device till the maximal tolerated pressure is not more than 16 cmH20 (TBD) for 30 minutes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
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

入选标准

  • Lung tumors and nodules with tumor motion greater than 1 cm on standard imaging
  • Left sided breast tumors with unfavorable anatomy, viz heart abutting chest wall
  • Upper abdominal tumors: Liver and Pancreas with tumor motion greater than 1 cm. (n=10)

排除标准

  • Under 18 years old
  • Inability to sign informed consent
  • Pregnancy,
  • Mental Illness,
  • Not legally competent

结局指标

主要结局

Reduction in amplitude of tumor motion

时间窗: 2 months

Measurement of the Internal Target Volume in cc

次要结局

  • Reduction of radiation dose to critical organs(2 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr. Zvi Symon MD

Chairman Radiation Oncology

Sheba Medical Center

研究点 (2)

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