Clinical Trial: Evaluation of Continuous Positive Airway Pressure for Tumor Motion Management in Radiotherapy

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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.

All patients must be able to tolerate CPAP and comply with daily treatment. 4D CT: CT simulation is the basis of conformal treatment planning [24, 25]. By using a slow acquisition time of 3 minutes the motion effects due to breathing can be captured and a 4D image generated. The tumor position can be imaged throughout the breathing cycle and a Maximum Intensity Projection (MIP) can be constructe
Sponsor: Sheba Medical Center

Current Primary Outcome: Reduction in amplitude of tumor motion [ Time Frame: 2 months ]

Measurement of the Internal Target Volume in cc


Original Primary Outcome: Same as current

Current Secondary Outcome: Reduction of radiation dose to critical organs [ Time Frame: 2 months ]

Mean Lung dose, Mean Heart dose measured in Gy


Original Secondary Outcome: Same as current

Information By: Sheba Medical Center

Dates:
Date Received: December 10, 2014
Date Started: December 2013
Date Completion: December 2015
Last Updated: December 18, 2014
Last Verified: December 2014