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

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: Recruiting
• Conditions: Lung Cancer; Left Sided Breast Cancer
• Intervention / Treatment: Device: Continuous Positive Airway Pressure; Other: Deep inspiratory breath hold; Other: Free Breath

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 (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chirag Shah, MD; Phone Number: 1-866-223-8100; Email: TaussigResearch@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
      • Contact: Chirag Shah, M.D.

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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.	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.	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.	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	Total Lung dosimetry will be measured in Grays.	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.	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).	At the time of Scan, " Day 1"
Treatment time with CPAP treatments	Treatment time will be measured for each fraction	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.	At the time of Scan, " Day 1"

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: Varian Medical Systems
• Investigators: Principal Investigator: Chirag Shah, MD, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2025

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): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: lung; cancer; radiation; CPAP; continuous positive airway pressure; stereotactic body radiation therapy; Deep inspiratory breath hold (DIBH)
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Unilateral Breast Neoplasms
• 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: Yes
• product manufactured in and exported from the U.S.: Yes