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NCT Number: NCT03422302

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

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.

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Key information

Conditions

Lung Carcinoma Lung Diseases Lung Neoplasms Malignant Respiratory Tract Neoplasm Metastatic Malignant Neoplasm in the Lung Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Julianne M. Pollard, MD

CONTACT

713-563-2591

Julianne M. Pollard, MD

PRINCIPAL_INVESTIGATOR

About this study

PRIMARY OBJECTIVES:

I. 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:

I. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biphasic Positive Airway Pressure

Device

Receive BiPAP

Other names: BiPAP, Biphasic positive airway pressure (BiPAP)

Computed Tomography

Procedure

Undergo CT simulation scans

Other names: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography

Continuous Positive Airway Pressure

Procedure

Receive CPAP

Other names: Continuous positive airway pressure (CPAP), CPAP

Deep Inspiration Breath Hold

Procedure

Complete DIBH

Other names: DIBH

Radiation Therapy Treatment Planning and Simulation

Radiation

Undergo CT simulation scans

Other names: Radiation Therapy Treatment Planning/Simulation

Stereotactic Body Radiation Therapy

Radiation

Undergo SBRT

Other names: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

Primary outcomes

  1. 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.

Secondary outcomes

  1. Increase in lung volume

    Time frame: Up to 10 days

    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

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

    Time frame: Up to 10 days

    The study will summarize the data with mean, standard deviation, median and range for continuous variables, and frequency count and percentage for categorical variables.

Study contacts

Contact information is provided by the study sponsor or research team.

Julianne M. Pollard, PHD

CONTACT

[email protected]

713-563-2591

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Feb 5, 2018
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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