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

NCT05142358 | Completed DMC

• 1 other identifier: CASE5Y21
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

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)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Total Lung dosimetry

  At the time of Scan, " Day 1"

• Cardiac dosimetry with CPAP as compared to free breathing

  At the time of Scan, " Day 1"

• Measure breast/chest wall or lung tumor motion as well as organ at risk motion

  At the time of Scan, " Day 1"

• Treatment time with CPAP treatments

  At the time of Scan, " Day 1"

• Confirm maintenance of inflation with CPAP using surface guidance

  At the time of Scan, " Day 1"

Study Arms (2)

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.

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.

Device: Continuous Positive Airway Pressure; Other: Deep inspiratory breath hold; Other: Free Breath

Interventions

Free Breath OTHER

Regular breathing

Also known as: Without DIBH

Lung SBRT; left-sided breast cancer

Continuous Positive Airway Pressure DEVICE

Use of CPAP device at the start of treatment planning.

Also known as: CPAP

Lung SBRT; left-sided breast cancer

Deep inspiratory breath hold OTHER

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

Also known as: DIBH

Lung SBRT; left-sided breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with right side breast cancer
• Patients who are unable to tolerate the CPAP device

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• Varian Medical Systems: collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Unilateral Breast Neoplasms; Neoplasms

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Sheeh Cherian, MD

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: December 2, 2021
• Study Start: October 19, 2022
• Primary Completion: January 28, 2026
• Study Completion: January 28, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

US (1)