Lung CancerNCT05142358
A Prospective Study to Evaluate Continuous Positive Airway Pressure Devices to Reduce Pulmonary Dose
A study testing Continuous Positive Airway Pressure, Deep inspiratory breath hold and Free Breath in people with Lung Cancer and Left Sided Breast Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Left Sided Breast Cancer
- What is being tested?
- Continuous Positive Airway Pressure, Deep inspiratory breath hold and Free Breath
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2022to 28 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with right side breast cancer
- Patients who are unable to tolerate the CPAP device
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
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.
Read the 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.
- Conditions
- Lung Cancer, Left Sided Breast Cancer
- Being tested
- Continuous Positive Airway Pressure, Deep inspiratory breath hold, Free Breath
- Keywords
- stereotactic body radiation therapy, continuous positive airway pressure, CPAP, radiation, cancer, lung, Deep inspiratory breath hold (DIBH)
- Medical subject headings
- Lung Neoplasms, Unilateral Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway PressureDevice
Also called CPAP
Use of CPAP device at the start of treatment planning.
Deep inspiratory breath holdOther
Also called DIBH
Treatment during breath holds leads to longer treatment times for patients and radiation oncology departments
Free BreathOther
Also called Without DIBH
Regular breathing
| Study group | Role | What they receive |
|---|---|---|
| left-sided breast cancer | Active comparator | 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. Receives: Device: Continuous Positive Airway Pressure; Other: Deep inspiratory breath hold; Other: Free Breath |
| Lung SBRT | Active comparator | 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. Receives: Device: Continuous Positive Airway Pressure; Other: Deep inspiratory breath hold; Other: Free Breath |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of Scan, " Day 1"
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.
Measured: At the time of Scan, " Day 1"
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.
Measured: At the time of Scan, " Day 1"
Secondary outcomes (5)
Total Lung dosimetry
Total Lung dosimetry will be measured in Grays.
Measured: At the time of Scan, " Day 1"
Cardiac dosimetry with CPAP as compared to free breathing
Cardiac dosimetry with CPAP as compared to free-breathing will be measured in Grays.
Measured: At the time of Scan, " Day 1"
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).
Measured: At the time of Scan, " Day 1"
Treatment time with CPAP treatments
Treatment time will be measured for each fraction
Measured: At the time of Scan, " Day 1"
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.
Measured: At the time of Scan, " Day 1"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start19 Oct 2022
- Primary completion28 Jan 2026
- Study completion28 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Varian Medical Systems
- Responsible party
- Sponsor
- Investigators
- Sheeh Cherian, MD, Principal investigator, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142358
- Sponsor's protocol ID
- CASE5Y21
- Status last verified
- Jan 2026
- First submitted
- 4 Oct 2021
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate Continuous Positive Airway Pressure Devices to Reduce Pulmonary Dose
- ClinicalTrials.gov ID
- NCT05142358
- Acronym / sponsor ID
- CASE5Y21
- Conditions
- Lung Cancer, Left Sided Breast Cancer
- Keywords
- stereotactic body radiation therapy, continuous positive airway pressure, CPAP, radiation, cancer, lung, Deep inspiratory breath hold (DIBH)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Varian Medical Systems
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- 28 Jan 2026 (actual)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| left-sided breast cancer | Active comparator | Device: Continuous Positive Airway Pressure, Other: Deep inspiratory breath hold, Other: Free BreathParticipants 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. |
| Lung SBRT | Active comparator | Device: Continuous Positive Airway Pressure, Other: Deep inspiratory breath hold, Other: Free BreathParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with left-sided breast cancers
- Patients undergoing lung SBRT
Key exclusion criteria (2 listed)
- Patients with right side breast cancer
- Patients who are unable to tolerate the CPAP device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Positive Airway PressureAlso: CPAPUse of CPAP device at the start of treatment planning. | Device | Lung SBRT, left-sided breast cancer |
| Deep inspiratory breath holdAlso: DIBHTreatment during breath holds leads to longer treatment times for patients and radiation oncology departments | Other | Lung SBRT, left-sided breast cancer |
| Free BreathAlso: Without DIBHRegular breathing | Other | Lung SBRT, left-sided breast cancer |
Primary outcome
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.
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.
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.
5 secondary outcomes
Total Lung dosimetry
Time frame: 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"
Measure breast/chest wall or lung tumor motion as well as organ at risk motion
Time frame: At the time of Scan, " Day 1"
Treatment time with CPAP treatments
Time frame: 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"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheeh Cherian, MD principal investigator
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Positive Airway Pressure, Deep inspiratory breath hold and Free Breath in people with Lung Cancer and Left Sided Breast Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosimetry comparison CPAP and free breathing. (time frame: At the time of Scan, " Day 1"). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.