Clinical trial NCT05142358: A Prospective Study to Evaluate Continuous Positive Airway Pressure Devices to Reduce Pulmonary Dose
Official title: A Prospective Study to Evaluate Continuous Positive Airway Pressure Devices to Reduce Pulmonary Dose
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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)
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Varian Medical Systems
First posted: 2021-12-02
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dosimetry comparison CPAP and free breathing.
timeFrame: At the time of Scan, " Day 1"
measure: Dosimetry comparison CPAP and free breathing.
timeFrame: At the time of Scan, " Day 1"
measure: Dosimetry comparison CPAP and free breathing.
timeFrame: At the time of Scan, " Day 1"
Secondary outcomes:
measure: Total Lung dosimetry
timeFrame: At the time of Scan, " Day 1"
measure: Cardiac dosimetry with CPAP as compared to free breathing
timeFrame: At the time of Scan, " Day 1"
measure: Measure breast/chest wall or lung tumor motion as well as organ at risk motion
timeFrame: At the time of Scan, " Day 1"
measure: Treatment time with CPAP treatments
timeFrame: At the time of Scan, " Day 1"
measure: Confirm maintenance of inflation with CPAP using surface guidance
timeFrame: At the time of Scan, " Day 1"
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
name: Sheeh Cherian, MD
role: PRINCIPAL_INVESTIGATOR
References: