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A Prospective Study to Evaluate Continuous Positive Airway Pressure Devices to Reduce Pulmonary Dose

Primary Purpose

Lung Cancer, Left Sided Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous Positive Airway Pressure
Deep inspiratory breath hold
Free Breath
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring stereotactic body radiation therapy, continuous positive airway pressure, CPAP, radiation, cancer, lung, Deep inspiratory breath hold (DIBH)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with left-sided breast cancers

    • Patients must be undergoing left breast/chest wall radiation with or without regional nodal irradiation
  • Patients undergoing lung SBRT

    • Primary lung cancers
    • Metastatic lung tumors

Exclusion Criteria:

  • Patients with right side breast cancer
  • Patients who are unable to tolerate the CPAP device

Sites / Locations

  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

left-sided breast cancer

Lung SBRT

Arm Description

Participants will come in for their regularly scheduled radiation planning and treatment. Participants will undergo three scans (with and without DIBH (i.e., free-breathing), with CPAP). Participants will also use the CPAP device before the CT scan, for which they will be educated and trained.

Participants will come in for their regularly scheduled radiation planning and treatment. Participants will undergo three scans (with and without DIBH (i.e., free-breathing), with CPAP). Participants will also use the CPAP device before the CT scan, for which they will be educated and trained.

Outcomes

Primary Outcome Measures

Dosimetry comparison CPAP and free breathing.
The primary objective will be to assess changes in lung dosimetry V5 on the affected side when using CPAP compared to free breathing will be measured in percentages.
Dosimetry comparison CPAP and free breathing.
The primary objective will be to assess changes in lung dosimetry V20 on the affected side when using CPAP compared to free-breathing will be measured in percentages.
Dosimetry comparison CPAP and free breathing.
The primary objective will be to assess changes in lung dosimetry mean lung on the affected side when using CPAP compared to free-breathing will be measured in Grays.

Secondary Outcome Measures

Total Lung dosimetry
Total Lung dosimetry will be measured in Grays.
Cardiac dosimetry with CPAP as compared to free breathing
Cardiac dosimetry with CPAP as compared to free-breathing will be measured in Grays.
Measure breast/chest wall or lung tumor motion as well as organ at risk motion
Simulation scans will be performed with CPAP and free breathing. The breast/chest wall, and tumors (lung SBRT), as well as lung and heart, will be contoured on each scan. Using the CPAP scan as a reference, we will assess breast/chest wall motion, lung tumor motion, and organ at risk (ex. heart, abdominal organs) motion with free-breathing scans for each patient and analyze by treatment site (breast vs. lung SBRT).
Treatment time with CPAP treatments
Treatment time will be measured for each fraction
Confirm maintenance of inflation with CPAP using surface guidance
At the time of simulation, investigators will create a surface rendering with the patient using CPAP. Investigators will assess maintenance of inflation when using CPAP where all three dimensions will be measured during treatment by comparing the surface rendering obtained during simulation with CPAP to the surface during treatment with CPAP, assessing for the greatest changes over the course of each fraction.

Full Information

First Posted
October 4, 2021
Last Updated
January 17, 2023
Sponsor
Case Comprehensive Cancer Center
Collaborators
Varian Medical Systems
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1. Study Identification

Unique Protocol Identification Number
NCT05142358
Brief Title
A Prospective Study to Evaluate Continuous Positive Airway Pressure Devices to Reduce Pulmonary Dose
Official Title
A Prospective Study to Evaluate Continuous Positive Airway Pressure Devices to Reduce Pulmonary Dose
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
Varian Medical Systems

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Data collection and assessment on patients with left-sided breast cancer or undergoing lung stereotactic body radiation therapy (SBRT) utilizing continuous positive airway pressure (CPAP) devices.
Detailed Description
Lung stereotactic body radiation therapy (SBRT) has emerged as a definitive treatment for patients with early-stage lung cancers as well as for patients with limited metastases to the lung. One challenge with the treatment of the lung is the risk of pulmonary toxicity, particularly for early-stage lungs cancers that are inoperable (those receiving primary lung SBRT) or those with metastatic cancers receiving systemic therapy that may impact pulmonary function (those receiving lung SBRT for metastatic cancers). Continuous positive airway pressure (CPAP) devices are commonly utilized for patients with obstructive sleep apnea. However, through the use of continuous pressure, lung volumes are increased. Preliminary data in patients undergoing breast radiation as well as lung radiation has demonstrated the safety and feasibility of such an approach, demonstrating increased lung volumes with decreases in heart dose6-8. Additional potential advantages of CPAP include increased ease of use for patients and the potential for cost savings as compared to traditional respiratory management techniques. This prospective study is to allow for the collection and assessment of data on patients with left-sided breast cancer or undergoing lung SBRT utilizing CPAP. This will allow for the assessment of lung doses with and without CPAP as well as cardiac doses. No additional changes to our standard of care breast or lung radiation will occur. With respect to the safety profile, CPAP is commonly used with limited toxicity concerns. The potential benefit of CPAP has reduced lung and heart doses and, consequently, radiation-related toxicities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Left Sided Breast Cancer
Keywords
stereotactic body radiation therapy, continuous positive airway pressure, CPAP, radiation, cancer, lung, Deep inspiratory breath hold (DIBH)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All participants will undergo standard of care radiation treatment. One additional CT scan will be performed with the use of a CPAP device to determine effect on dosimetry.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
left-sided breast cancer
Arm Type
Active Comparator
Arm Description
Participants will come in for their regularly scheduled radiation planning and treatment. Participants will undergo three scans (with and without DIBH (i.e., free-breathing), with CPAP). Participants will also use the CPAP device before the CT scan, for which they will be educated and trained.
Arm Title
Lung SBRT
Arm Type
Active Comparator
Arm Description
Participants will come in for their regularly scheduled radiation planning and treatment. Participants will undergo three scans (with and without DIBH (i.e., free-breathing), with CPAP). Participants will also use the CPAP device before the CT scan, for which they will be educated and trained.
Intervention Type
Device
Intervention Name(s)
Continuous Positive Airway Pressure
Other Intervention Name(s)
CPAP
Intervention Description
Use of CPAP device at the start of treatment planning.
Intervention Type
Other
Intervention Name(s)
Deep inspiratory breath hold
Other Intervention Name(s)
DIBH
Intervention Description
Treatment during breath holds leads to longer treatment times for patients and radiation oncology departments
Intervention Type
Other
Intervention Name(s)
Free Breath
Other Intervention Name(s)
Without DIBH
Intervention Description
Regular breathing
Primary Outcome Measure Information:
Title
Dosimetry comparison CPAP and free breathing.
Description
The primary objective will be to assess changes in lung dosimetry V5 on the affected side when using CPAP compared to free breathing will be measured in percentages.
Time Frame
At the time of Scan, " Day 1"
Title
Dosimetry comparison CPAP and free breathing.
Description
The primary objective will be to assess changes in lung dosimetry V20 on the affected side when using CPAP compared to free-breathing will be measured in percentages.
Time Frame
At the time of Scan, " Day 1"
Title
Dosimetry comparison CPAP and free breathing.
Description
The primary objective will be to assess changes in lung dosimetry mean lung on the affected side when using CPAP compared to free-breathing will be measured in Grays.
Time Frame
At the time of Scan, " Day 1"
Secondary Outcome Measure Information:
Title
Total Lung dosimetry
Description
Total Lung dosimetry will be measured in Grays.
Time Frame
At the time of Scan, " Day 1"
Title
Cardiac dosimetry with CPAP as compared to free breathing
Description
Cardiac dosimetry with CPAP as compared to free-breathing will be measured in Grays.
Time Frame
At the time of Scan, " Day 1"
Title
Measure breast/chest wall or lung tumor motion as well as organ at risk motion
Description
Simulation scans will be performed with CPAP and free breathing. The breast/chest wall, and tumors (lung SBRT), as well as lung and heart, will be contoured on each scan. Using the CPAP scan as a reference, we will assess breast/chest wall motion, lung tumor motion, and organ at risk (ex. heart, abdominal organs) motion with free-breathing scans for each patient and analyze by treatment site (breast vs. lung SBRT).
Time Frame
At the time of Scan, " Day 1"
Title
Treatment time with CPAP treatments
Description
Treatment time will be measured for each fraction
Time Frame
At the time of Scan, " Day 1"
Title
Confirm maintenance of inflation with CPAP using surface guidance
Description
At the time of simulation, investigators will create a surface rendering with the patient using CPAP. Investigators will assess maintenance of inflation when using CPAP where all three dimensions will be measured during treatment by comparing the surface rendering obtained during simulation with CPAP to the surface during treatment with CPAP, assessing for the greatest changes over the course of each fraction.
Time Frame
At the time of Scan, " Day 1"

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with left-sided breast cancers Patients must be undergoing left breast/chest wall radiation with or without regional nodal irradiation Patients undergoing lung SBRT Primary lung cancers Metastatic lung tumors Exclusion Criteria: Patients with right side breast cancer Patients who are unable to tolerate the CPAP device
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chirag Shah, MD
Phone
1-866-223-8100
Email
TaussigResearch@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chirag Shah, MD
Organizational Affiliation
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chirag Shah, M.D.

12. IPD Sharing Statement

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A Prospective Study to Evaluate Continuous Positive Airway Pressure Devices to Reduce Pulmonary Dose

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