Recruiting

CPAP vs. DIBH

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT03422302

Conditions

Lung Carcinoma

Malignant Respiratory Tract Neoplasm

Metastatic Malignant Neoplasm in the Lung

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biphasic Positive Airway Pressure

Computed Tomography

Continuous Positive Airway Pressure

Deep Inspiration Breath Hold

Radiation Therapy Treatment Planning and Simulation

Study Details

Brief 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. 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.

Conditions

Lung Carcinoma

Malignant Respiratory Tract Neoplasm

Metastatic Malignant Neoplasm in the Lung

Study ID

NCT03422302

Start date

Mar 16, 2018

Status verified date

Aug, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • The patient will receive stereotactic body radiotherapy in the Thoracic Radiation Oncolcogy Service at MD Anderson.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Treatment (CT simulation, CPAP, DIBH, SBRT, BiPAP)

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.

Interventions

Biphasic Positive Airway Pressure

Receive BiPAP

Computed Tomography

Undergo CT simulation scans

Continuous Positive Airway Pressure

Receive CPAP

Deep Inspiration Breath Hold

Complete DIBH

Radiation Therapy Treatment Planning and Simulation

Undergo CT simulation scans

Stereotactic Body Radiation Therapy

Undergo SBRT

Primary outcome measure

  • Estimation of decrease in tumor motion [ Time Frame: Up to 10 days ]

Central Contacts and Locations

Central contacts

Julianne M. Pollard, PHD

713-563-2591JMPollard@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Julianne M. Pollard, MD

713-563-2591

Principal Investigator:

Julianne M. Pollard, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-11.