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

Lung Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03422302
• Other study ID #: 2016-1105
• Secondary ID: NCI-2018-0088420
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: March 16, 2018
• Est. completion date: May 31, 2028

Study information

• Verified date: June 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: May 31, 2028
• Est. primary completion date: May 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Carcinoma
• Malignant Respiratory Tract Neoplasm
• Metastatic Malignant Neoplasm in the Lung
• Neoplasms
• Respiratory Tract Neoplasms

Intervention

Device:
• Biphasic Positive Airway Pressure
Receive BiPAP

Procedure:
• Computed Tomography
Undergo CT simulation scans
• Continuous Positive Airway Pressure
Receive CPAP
• Deep Inspiration Breath Hold
Complete DIBH

Radiation:
• Radiation Therapy Treatment Planning and Simulation
Undergo CT simulation scans
• Stereotactic Body Radiation Therapy
Undergo SBRT

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

•   University of Texas MD Anderson Cancer Center Website