Clinical Trials Directory

Trials / Completed

CompletedNCT05142358

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
8 (actual)
Sponsor
Case Comprehensive Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEContinuous Positive Airway PressureUse of CPAP device at the start of treatment planning.
OTHERDeep inspiratory breath holdTreatment during breath holds leads to longer treatment times for patients and radiation oncology departments
OTHERFree BreathRegular breathing

Timeline

Start date
2022-10-19
Primary completion
2026-01-28
Completion
2026-01-28
First posted
2021-12-02
Last updated
2026-02-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05142358. Inclusion in this directory is not an endorsement.