Continuous Positive Airway Pressure Device or Deep Inspiration Breath Hold in Reducing Tumor Motion in Patients Undergoing Stereotactic Body Radiation Therapy for Lung Cancer
Primary Purpose
Lung Carcinoma, Malignant Respiratory Tract Neoplasm, Metastatic Malignant Neoplasm in the Lung
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Biphasic Positive Airway Pressure
Computed Tomography
Continuous Positive Airway Pressure
Deep Inspiration Breath Hold
Radiation Therapy Treatment Planning and Simulation
Stereotactic Body Radiation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Lung Carcinoma
Eligibility Criteria
Inclusion Criteria:
- The patient has a biopsy-proven radio-opaque (visible by computed tomography [CT]) lung cancer or secondary metastasis to the lung.
- The patient will receive thoracic stereotactic body radiotherapy 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.
Sites / Locations
- M D Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (CT simulation, CPAP, DIBH, SBRT, BiPAP)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
Full Information
NCT ID
NCT03422302
First Posted
January 26, 2018
Last Updated
June 28, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03422302
Brief Title
Continuous Positive Airway Pressure Device or Deep Inspiration Breath Hold in Reducing Tumor Motion in Patients Undergoing Stereotactic Body Radiation Therapy for Lung Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2018 (Actual)
Primary Completion Date
May 31, 2028 (Anticipated)
Study Completion Date
May 31, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Carcinoma, Malignant Respiratory Tract Neoplasm, Metastatic Malignant Neoplasm in the Lung
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment (CT simulation, CPAP, DIBH, SBRT, BiPAP)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Biphasic Positive Airway Pressure
Other Intervention Name(s)
BiPAP, Biphasic positive airway pressure (BiPAP)
Intervention Description
Receive BiPAP
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography
Intervention Description
Undergo CT simulation scans
Intervention Type
Procedure
Intervention Name(s)
Continuous Positive Airway Pressure
Other Intervention Name(s)
Continuous positive airway pressure (CPAP), CPAP
Intervention Description
Receive CPAP
Intervention Type
Procedure
Intervention Name(s)
Deep Inspiration Breath Hold
Other Intervention Name(s)
DIBH
Intervention Description
Complete DIBH
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy Treatment Planning and Simulation
Other Intervention Name(s)
Radiation Therapy Treatment Planning/Simulation
Intervention Description
Undergo CT simulation scans
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy
Other Intervention Name(s)
SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Intervention Description
Undergo SBRT
Primary Outcome Measure Information:
Title
Estimation of decrease in tumor motion
Description
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.
Time Frame
Up to 10 days
Secondary Outcome Measure Information:
Title
Increase in lung volume
Description
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
Time Frame
Up to 10 days
Title
Assessment of time to deliver the planned radiation dose by using the most appropriate method
Description
The study will summarize the data with mean, standard deviation, median and range for continuous variables, and frequency count and percentage for categorical variables.
Time Frame
Up to 10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient has a biopsy-proven radio-opaque (visible by computed tomography [CT]) lung cancer or secondary metastasis to the lung.
The patient will receive thoracic stereotactic body radiotherapy 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julianne M. Pollard, PHD
Phone
713-563-2591
Email
JMPollard@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julianne M Pollard
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julianne M. Pollard
Phone
713-563-2591
First Name & Middle Initial & Last Name & Degree
Julianne M. Pollard
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website
Learn more about this trial
Continuous Positive Airway Pressure Device or Deep Inspiration Breath Hold in Reducing Tumor Motion in Patients Undergoing Stereotactic Body Radiation Therapy for Lung Cancer
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