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

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Left Sided Breast Cancer; Lung Cancer

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05142358

CASE5Y21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

left-sided breast cancer

Active Comparator group

Description:

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.

Treatment:

Other: Deep inspiratory breath hold

Other: Free Breath

Device: Continuous Positive Airway Pressure

Lung SBRT

Active Comparator group

Description:

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.

Treatment:

Other: Deep inspiratory breath hold

Other: Free Breath

Device: Continuous Positive Airway Pressure