ClinicalTrials.gg
CompletedNCT05142358Updated Feb 2, 2026

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

An interventional study of Continuous Positive Airway Pressure and Deep inspiratory breath hold in Lung Cancer and Left Sided Breast Cancer, sponsored by Case Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-02.

Sponsored by Case Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 26 studies in Lung Neoplasms by Case Comprehensive Cancer Center — 1 open to participants now, 1 under way, none of them phase 3. Lung Neoplasms · Case Comprehensive Cancer Center.

Enrollment
11th of 19
8 · median 13
Started
2022
the only one that year
No phase
3 of 26
none open now
Registered
25th of 26
by date

Among the 26 studies in Lung Neoplasms by Case Comprehensive Cancer Center, this one is the 11th largest by enrollment of the 19 interventional ones that give a count, is the only one that started in 2022, is one of 3 with no phase, and was the 25th registered.

Lung Neoplasms

5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.

Browse Lung Neoplasms studies →

Open to participants now

1 of the 26 studies in Lung Neoplasms by Case Comprehensive Cancer Center is open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

Where they have run

Who these studies take

Of the 996 Lung Neoplasms studies recruiting now, 683 (69%) set no upper age limit and 142 (14%) stop at 75 or younger; 45 take children under 18; 142 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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 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.

03

Conditions studied

  • Lung Cancer
  • Left Sided Breast Cancer

Keywords

  • stereotactic body radiation therapy
  • continuous positive airway pressure
  • CPAP
  • radiation
  • cancer
  • lung
  • Deep inspiratory breath hold (DIBH)
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
    • lung tumors

Exclusion criteria

Exclusion Criteria:

  • Patients with right side breast cancer
  • Patients who are unable to tolerate the CPAP device
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • 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 · Other: Deep inspiratory breath hold · Other: Free Breath

  • 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 · Other: Deep inspiratory breath hold · Other: Free Breath

Interventions

  • DeviceContinuous Positive Airway Pressure

    Use of CPAP device at the start of treatment planning.

    Also known as: CPAP

  • OtherDeep inspiratory breath hold

    Treatment during breath holds leads to longer treatment times for patients and radiation oncology departments

    Also known as: DIBH

  • OtherFree Breath

    Regular breathing

    Also known as: Without DIBH

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At the time of Scan, " Day 1"

  2. 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.

    Time frame: At the time of Scan, " Day 1"

  3. 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.

    Time frame: At the time of Scan, " Day 1"

Secondary outcomes

  1. Total Lung dosimetry

    Total Lung dosimetry will be measured in Grays.

    Time frame: At the time of Scan, " Day 1"

  2. Cardiac dosimetry with CPAP as compared to free breathing

    Cardiac dosimetry with CPAP as compared to free-breathing will be measured in Grays.

    Time frame: At the time of Scan, " Day 1"

  3. 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).

    Time frame: At the time of Scan, " Day 1"

  4. Treatment time with CPAP treatments

    Treatment time will be measured for each fraction

    Time frame: At the time of Scan, " Day 1"

  5. 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.

    Time frame: At the time of Scan, " Day 1"

07

Study locations

1 site
  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
    Cleveland, Ohio 44195, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2022 to primary completion in Jan 2026, 39 months.

Of 864 non-industry interventional studies with no phase under Lung Neoplasms, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 68. This study's 39 months is above that.

Counting every sponsor, half of 915 studies reached it within 34 months; a quarter within 15 and three quarters within 67.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 4, 2021
First posted
Dec 2, 2021
StartActual
Oct 19, 2022
Primary completionActual
Jan 28, 2026
CompletionActual
Jan 28, 2026
Last update
Feb 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05142358
Responsible party
Sponsor
First posted
Dec 2, 2021
Start date
Oct 19, 2022
Primary completion
Jan 28, 2026
Completion
Jan 28, 2026
Last update
Feb 2, 2026

Study contacts

Sheeh Cherian, MD
principal investigator · Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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