What this study is
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.
What's being tested
- Biphasic Positive Airway Pressure
Intervention · DEVICE
Receive BiPAP
- Computed Tomography
Intervention · PROCEDURE
- Continuous Positive Airway Pressure
Intervention · PROCEDURE
Receive CPAP
- Deep Inspiration Breath Hold
Intervention · PROCEDURE
Complete DIBH
- Radiation Therapy Treatment Planning and Simulation
Intervention · RADIATION
- Stereotactic Body Radiation Therapy
Intervention · RADIATION
Undergo SBRT
Both Computed Tomography and Radiation Therapy Treatment Planning and Simulation
Undergo CT simulation scans
Study details
- Official title
- Measuring the Effectiveness of a Continuous Positive Airway Pressure (CPAP) Device to Reduce Tumor Motion and Increase Lung Volume Expansion in Patients Undergoing Stereotactic Body Radiotherapy (SBRT) for Tumors That Move With Respiration
- Sponsor
- M.D. Anderson Cancer Center
- Conditions
- Lung Carcinoma · Malignant Respiratory Tract Neoplasm · Metastatic Malignant Neoplasm in the Lung
- Enrolling
- 30 people
- Starts
- 2018-03-16
- Est. completion
- 2028-05-31
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- The patient will receive stereotactic body radiotherapy in the Thoracic Radiation Oncolcogy Service at MD Anderson.
You can't join if
- 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.
- The patient has sustained trauma or burns to the face.
- The patient has undergone any facial, esophageal, gastric or sinus surgery within the last 3 months.
- The patient has idiopathic pulmonary fibrosis (IPF) as documented in their medical history.
- Adults who are unable to consent, individuals who are not yet adults, pregnant women and prisoners will be excluded from this study.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openM D Anderson Cancer Center
Houston, Texas, United States
- Julianne M. Pollard, MD · Contact713-563-2591
- Julianne M. Pollard, MD · Principal investigator
Recruiting
Study team
Sponsor
M.D. Anderson Cancer Center
Study ID 2016-1105
Principal investigator
Julianne M Pollard
M.D. Anderson Cancer Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.