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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05142358
• Other study ID #: CASE5Y21
• Status: Recruiting
• Phase: N/A
• Start date: October 19, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: January 2024
• Source: Case Comprehensive Cancer Center
• Contact: Chirag Shah, MD
• Phone: 1-866-223-8100
• Email: TaussigResearch[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Left Sided Breast Cancer
• Lung Cancer

Intervention

Device:
• Continuous Positive Airway Pressure
Use of CPAP device at the start of treatment planning.

Other:
• Deep inspiratory breath hold
Treatment during breath holds leads to longer treatment times for patients and radiation oncology departments
• Free Breath
Regular breathing

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	Varian Medical Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At the time of Scan, " Day 1"
Primary	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.	At the time of Scan, " Day 1"
Primary	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.	At the time of Scan, " Day 1"
Secondary	Total Lung dosimetry	Total Lung dosimetry will be measured in Grays.	At the time of Scan, " Day 1"
Secondary	Cardiac dosimetry with CPAP as compared to free breathing	Cardiac dosimetry with CPAP as compared to free-breathing will be measured in Grays.	At the time of Scan, " Day 1"
Secondary	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).	At the time of Scan, " Day 1"
Secondary	Treatment time with CPAP treatments	Treatment time will be measured for each fraction	At the time of Scan, " Day 1"
Secondary	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.	At the time of Scan, " Day 1"