Lung CarcinomaNCT03422302
Continuous Positive Airway Pressure Device or Deep Inspiration Breath Hold in Reducing Tumor Motion in Patients Undergoing Stereotactic Body Radiation Therapy for Lung Cancer
A study testing Biphasic Positive Airway Pressure, Computed Tomography and Continuous Positive Airway Pressure in people with Lung Carcinoma and Malignant Respiratory Tract Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Carcinoma, Malignant Respiratory Tract Neoplasm, Metastatic Malignant Neoplasm in the Lung
- What is being tested?
- Biphasic Positive Airway Pressure, Computed Tomography and Continuous Positive Airway Pressure
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2018to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient will receive stereotactic body radiotherapy in the Thoracic Radiation Oncolcogy Service at MD Anderson.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Julianne M. Pollard, MD, 713-563-2591
Julianne M. Pollard, MD
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To compare the two methods of tumor motion management, continuous positive airway pressure (CPAP) and deep inspiration breath hold (DIBH) and to estimate the decrease in tumor motion from free breathing for CPAP and DIBH.
SECONDARY OBJECTIVES:
- To determine if CPAP is a more time-efficient option for tumor motion management than is DIBH.
Ia. Determine if CPAP is better tolerated by patients than is DIBH. Ib. Determine the reproducibility of lung expansion and tumor motion reduction by CPAP.
Ic. Determine if the dosimetric coverage of the tumor and the sparing of the normal tissues with CPAP is comparable to that with DIBH.
Id. Measure treatment time differences between CPAP and breath hold (DIBH) treatments.
OUTLINE:
Patients undergo free-breathing, DIBH, and CPAP CT simulation scans. If patient has difficulty exhaling on CPAP, then patient undergo biphasic positive airway pressure (BiPAP) CT simulation. The attending physician then compares all 3 simulation treatment plans (free-breathing, DIBH, and CPAP/BiPAP) and determines which method to use during SBRT. If CPAP/BiPAP is chosen as preferred method, patients wear CPAP/BiPAP over 1 hour prior to SBRT, then again during SBRT over 30-60 minutes. All other patients complete free-breathing or DIBH during SBRT over 30-60 minutes.
- Conditions
- Lung Carcinoma, Malignant Respiratory Tract Neoplasm, Metastatic Malignant Neoplasm in the Lung
- Being tested
- Biphasic Positive Airway Pressure, Computed Tomography, Continuous Positive Airway Pressure, Deep Inspiration Breath Hold, Radiation Therapy Treatment Planning and Simulation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biphasic Positive Airway PressureDevice
Also called BiPAP, Biphasic positive airway pressure (BiPAP)
Receive BiPAP
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, computerized tomography
Undergo CT simulation scans
Continuous Positive Airway PressureProcedure or surgery
Also called Continuous positive airway pressure (CPAP), CPAP
Receive CPAP
Deep Inspiration Breath HoldProcedure or surgery
Also called DIBH
Complete DIBH
Radiation Therapy Treatment Planning and SimulationRadiation
Also called Radiation Therapy Treatment Planning/Simulation
Undergo CT simulation scans
Stereotactic Body Radiation TherapyRadiation
Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Undergo SBRT
| Study group | Role | What they receive |
|---|---|---|
| Treatment (CT simulation, CPAP, DIBH, SBRT, BiPAP) | Experimental | Patients undergo free-breathing, DIBH, and CPAP CT simulation scans. If patient has difficulty exhaling on CPAP, then patient undergo BiPAP CT simulation. The attending physician then compares all 3 simulation treatment plans (free-breathing, DIBH, and CPAP/BiPAP) and determines which method to use during SBRT. If CPAP/BiPAP is chosen as preferred method, patients wear CPAP/BiPAP over 1 hour prior to SBRT, then again during SBRT over 30-60 minutes. All other patients complete free-breathing or DIBH during SBRT over 30-60 minutes. Receives: Device: Biphasic Positive Airway Pressure; Procedure: Computed Tomography; Procedure: Continuous Positive Airway Pressure; Procedure: Deep Inspiration Breath Hold; Radiation: Radiation Therapy Treatment Planning and Simulation; Radiation: Stereotactic Body Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 10 days
Secondary outcomes (2)
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
Measured: Up to 10 days
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.
Measured: Up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start16 Mar 2018
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Julianne M Pollard, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422302
- Sponsor's protocol ID
- 2016-1105
- Other IDs
- NCI-2018-00884, 2016-1105
- Status last verified
- Aug 2026
- First submitted
- 26 Jan 2018
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03422302
- Acronym / sponsor ID
- 2016-1105
- Conditions
- Lung Carcinoma, Malignant Respiratory Tract Neoplasm, Metastatic Malignant Neoplasm in the Lung
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To compare the two methods of tumor motion management, continuous positive airway pressure (CPAP) and deep inspiration breath hold (DIBH) and to estimate the decrease in tumor motion from free breathing for CPAP and DIBH.
SECONDARY OBJECTIVES:
- To determine if CPAP is a more time-efficient option for tumor motion management than is DIBH.
Ia. Determine if CPAP is better tolerated by patients than is DIBH. Ib. Determine the reproducibility of lung expansion and tumor motion reduction by CPAP.
Ic. Determine if the dosimetric coverage of the tumor and the sparing of the normal tissues with CPAP is comparable to that with DIBH.
Id. Measure treatment time differences between CPAP and breath hold (DIBH) treatments.
OUTLINE:
Patients undergo free-breathing, DIBH, and CPAP CT simulation scans. If patient has difficulty exhaling on CPAP, then patient undergo biphasic positive airway pressure (BiPAP) CT simulation. The attending physician then compares all 3 simulation treatment plans (free-breathing, DIBH, and CPAP/BiPAP) and determines which method to use during SBRT. If CPAP/BiPAP is chosen as preferred method, patients wear CPAP/BiPAP over 1 hour prior to SBRT, then again during SBRT over 30-60 minutes. All other patients complete free-breathing or DIBH during SBRT over 30-60 minutes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (CT simulation, CPAP, DIBH, SBRT, BiPAP) | Experimental | Device: Biphasic Positive Airway Pressure, Procedure: Computed Tomography, Procedure: Continuous Positive Airway Pressure, Procedure: Deep Inspiration Breath Hold, Radiation: Radiation Therapy Treatment Planning and Simulation, Radiation: Stereotactic Body Radiation TherapyPatients undergo free-breathing, DIBH, and CPAP CT simulation scans. If patient has difficulty exhaling on CPAP, then patient undergo BiPAP CT simulation. The attending physician then compares all 3 simulation treatment plans (free-breathing, DIBH, and CPAP/BiPAP) and determines which method to use during SBRT. If CPAP/BiPAP is chosen as preferred method, patients wear CPAP/BiPAP over 1 hour prior to SBRT, then again during SBRT over 30-60 minutes. All other patients complete free-breathing or DIBH during SBRT over 30-60 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patient will receive stereotactic body radiotherapy in the Thoracic Radiation Oncolcogy Service at MD Anderson.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biphasic Positive Airway PressureAlso: BiPAP, Biphasic positive airway pressure (BiPAP)Receive BiPAP | Device | Treatment (CT simulation, CPAP, DIBH, SBRT, BiPAP) |
| Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, computerized tomographyUndergo CT simulation scans | Procedure or surgery | Treatment (CT simulation, CPAP, DIBH, SBRT, BiPAP) |
| Continuous Positive Airway PressureAlso: Continuous positive airway pressure (CPAP), CPAPReceive CPAP | Procedure or surgery | Treatment (CT simulation, CPAP, DIBH, SBRT, BiPAP) |
| Deep Inspiration Breath HoldAlso: DIBHComplete DIBH | Procedure or surgery | Treatment (CT simulation, CPAP, DIBH, SBRT, BiPAP) |
| Radiation Therapy Treatment Planning and SimulationAlso: Radiation Therapy Treatment Planning/SimulationUndergo CT simulation scans | Radiation | Treatment (CT simulation, CPAP, DIBH, SBRT, BiPAP) |
| Stereotactic Body Radiation TherapyAlso: SABR, SBRT, Stereotactic Ablative Body Radiation TherapyUndergo SBRT | Radiation | Treatment (CT simulation, CPAP, DIBH, SBRT, BiPAP) |
Primary outcome
Estimation of decrease in tumor motion
Time frame: Up to 10 days
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.
2 secondary outcomes
Increase in lung volume
Time frame: Up to 10 days
Assessment of time to deliver the planned radiation dose by using the most appropriate method
Time frame: Up to 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julianne M Pollard principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biphasic Positive Airway Pressure, Computed Tomography and Continuous Positive Airway Pressure in people with Lung Carcinoma and Malignant Respiratory Tract Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julianne M. Pollard, PHD (713-563-2591, JMPollard@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of decrease in tumor motion (time frame: Up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.