Continuous Positive Airway Pressure Device or Deep Inspiration Breath Hold in Reducing Tumor Motion in Patients Undergoing Stereotactic Body Radiation Therapy for Lung Cancer

NCT03422302 | Recruiting FDA Device

• 2 other identifiers: 2016-1105NCI-2018-00884
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 10 days

Secondary Outcomes (2)

• Increase in lung volume

  Up to 10 days

• Assessment of time to deliver the planned radiation dose by using the most appropriate method

  Up to 10 days

Study Arms (1)

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.

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

Interventions

Biphasic Positive Airway Pressure DEVICE

Receive BiPAP

Also known as: BiPAP, Biphasic positive airway pressure (BiPAP)

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

Computed Tomography PROCEDURE

Undergo CT simulation scans

Also known as: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography

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

Continuous Positive Airway Pressure PROCEDURE

Receive CPAP

Also known as: Continuous positive airway pressure (CPAP), CPAP

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

Deep Inspiration Breath Hold PROCEDURE

Complete DIBH

Also known as: DIBH

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

Radiation Therapy Treatment Planning and Simulation RADIATION

Undergo CT simulation scans

Also known as: Radiation Therapy Treatment Planning/Simulation

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

Stereotactic Body Radiation Therapy RADIATION

Undergo SBRT

Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Continuous Positive Airway Pressure; Radiosurgery

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Julianne M Pollard

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julianne M. Pollard, PHD

CONTACT

713-563-2591; JMPollard@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: February 5, 2018
• Study Start: March 16, 2018
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: January 27, 2026

Record last verified: 2025-08

Locations

US (1)