About this trial
This pilot phase I/II trial studies how well a continuous positive airway pressure device or deep inspiration breath hold works in reducing tumor movement in patients undergoing stereotactic body radiation therapy (SBRT) for lung cancer. The continuous positive airway pressure device works by blowing air into the lungs while patients wear a face mask or nozzle to help expand their airways and lungs. Deep inspiration breath hold is a standard technique that uses active breath-holding to restrict movement of the body. Using a continuous positive airway pressure device may work better than deep inspiration breath hold in lowering the amount of tumor movement during stereotactic radiation body therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patient will receive stereotactic body radiotherapy in the Thoracic Radiation Oncolcogy Service at MD Anderson.
Disqualifiers
The patient has a contra-indication for using a CPAP device.
The patient has not signed a study-specific informed consent for this study.
The patient is uncooperative.
The patient has reduced consciousness.
Trial design
Single group
Treatments tested in this trial
Biphasic Positive Airway Pressure
DeviceReceive BiPAP
Computed Tomography
Procedure/SurgeryUndergo CT simulation scans
Continuous Positive Airway Pressure
Procedure/SurgeryReceive CPAP
Deep Inspiration Breath Hold
Procedure/SurgeryComplete DIBH
Radiation Therapy Treatment Planning and Simulation
RadiationUndergo CT simulation scans
Stereotactic Body Radiation Therapy
RadiationUndergo SBRT
Treatment groups
Trial outcomes
Primary outcomes
Estimation of decrease in tumor motion
Paired t-test will be used to compare continuous positive airway pressure (CPAP) to deep inspiration breath hold (DIBH) in the decrease of tumor motion from free breathing. Linear regression may be used to evaluate the difference between CPAP and DIBH in the decrease of tumor motion from free breathing with the adjustment of important demographic and clinical variables in the model.
Secondary outcomes
Increase in lung volume
Increase in lung volume to be determined by using DIBH or CPAP from free breathing. Linear regression may be used to evaluate the difference between CPAP and DIBH in the increase of lung volume from free breathing with the adjustment of important demographic and clinical variables in the model. The study will summarize the data with mean, standard deviation, median and range for continuous variables, and frequency count and percentage for categorical variables
Assessment of time to deliver the planned radiation dose by using the most appropriate method
The study will summarize the data with mean, standard deviation, median and range for continuous variables, and frequency count and percentage for categorical variables.
Sponsors and contacts
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M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator