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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Carcinoma; Malignant Respiratory Tract Neoplasm; Metastatic Malignant Neoplasm in the Lung
• Intervention / Treatment: Radiation: Stereotactic Body Radiation Therapy; 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

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Julianne M. Pollard, PHD; Phone Number: 713-563-2591; Email: JMPollard@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Radiation: Stereotactic Body Radiation Therapy; Undergo SBRT; Other Names: SBRT; SABR; Stereotactic Ablative Body Radiation Therapy; Device: Biphasic Positive Airway Pressure; Receive BiPAP; Other Names: BiPAP; Biphasic positive airway pressure (BiPAP); Procedure: Computed Tomography; Undergo CT simulation scans; Other Names: CT; CAT; CAT Scan; Computerized Axial Tomography; tomography; computerized tomography; CT SCAN; Procedure: Continuous Positive Airway Pressure; Receive CPAP; Other Names: CPAP; Continuous positive airway pressure (CPAP); Procedure: Deep Inspiration Breath Hold; Complete DIBH; Other Names: DIBH; Radiation: Radiation Therapy Treatment Planning and Simulation; Undergo CT simulation scans; Other Names: Radiation Therapy Treatment Planning/Simulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Up to 10 days

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Julianne M Pollard, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2018
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: January 26, 2018
• First Submitted That Met QC Criteria: February 2, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Estimated): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Site; Thoracic Neoplasms; Neoplasms; Respiratory Tract Neoplasms
• Other Study ID Numbers: 2016-1105 (Other Identifier: M D Anderson Cancer Center); NCI-2018-00884 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes