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

January 29, 2026 updated by: Case Comprehensive Cancer Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: left-sided breast cancer
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.
Device: Continuous Positive Airway Pressure
Use of CPAP device at the start of treatment planning.
Other Names:
  • CPAP
Other: Deep inspiratory breath hold
Treatment during breath holds leads to longer treatment times for patients and radiation oncology departments
Other Names:
  • DIBH
Other: Free Breath
Regular breathing
Other Names:
  • Without DIBH
Active Comparator: Lung SBRT
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.
Device: Continuous Positive Airway Pressure
Use of CPAP device at the start of treatment planning.
Other Names:
  • CPAP
Other: Deep inspiratory breath hold
Treatment during breath holds leads to longer treatment times for patients and radiation oncology departments
Other Names:
  • DIBH
Other: Free Breath
Regular breathing
Other Names:
  • Without DIBH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dosimetry comparison CPAP and free breathing.
Time Frame: At the time of Scan, " Day 1"
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.
At the time of Scan, " Day 1"
Dosimetry comparison CPAP and free breathing.
Time Frame: At the time of Scan, " Day 1"
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.
At the time of Scan, " Day 1"
Dosimetry comparison CPAP and free breathing.
Time Frame: At the time of Scan, " Day 1"
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.
At the time of Scan, " Day 1"

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Lung dosimetry
Time Frame: At the time of Scan, " Day 1"
Total Lung dosimetry will be measured in Grays.
At the time of Scan, " Day 1"
Cardiac dosimetry with CPAP as compared to free breathing
Time Frame: At the time of Scan, " Day 1"
Cardiac dosimetry with CPAP as compared to free-breathing will be measured in Grays.
At the time of Scan, " Day 1"
Measure breast/chest wall or lung tumor motion as well as organ at risk motion
Time Frame: At the time of Scan, " Day 1"
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).
At the time of Scan, " Day 1"
Treatment time with CPAP treatments
Time Frame: At the time of Scan, " Day 1"
Treatment time will be measured for each fraction
At the time of Scan, " Day 1"
Confirm maintenance of inflation with CPAP using surface guidance
Time Frame: At the time of Scan, " Day 1"
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.
At the time of Scan, " Day 1"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Collaborators

Varian Medical Systems

Investigators

  • Principal Investigator: Sheeh Cherian, MD, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2022

Primary Completion (Actual)

January 28, 2026

Study Completion (Actual)

January 28, 2026

Study Registration Dates

First Submitted

October 4, 2021

First Submitted That Met QC Criteria

November 19, 2021

First Posted (Actual)

December 2, 2021

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASE5Y21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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