The goal of this clinical trial is to learn if using an incentive spirometer can reduce lung problems in people with advanced lung cancer who are receiving chemotherapy and radiation therapy. The main questions the study aims to answer are:
Does using an incentive spirometer lower the chances of developing lung inflammation (pneumonitis)? Does it improve overall survival and quality of life?
Participants will:
Use an incentive spirometer, a device that helps with deep breathing, 10 times every hour while awake.
Continue using the spirometer daily during treatment and for up to three months after treatment.
Complete quality of life assessments at the start of the study and at 3, 6, and 12 months.
Researchers will compare the results to see if the incentive spirometer helps reduce lung problems and improves participants\' well-being during and after their cancer treatment.
Confirmed diagnosis of advanced non-small-cell lung cancer
Performance status (ECOG 0-1)
Eligible for concurrent chemotherapy and radiation
18 years or older
Previous lung or thoracic surgery
Enrollment in another pulmonary intervention trial
Home oxygen usage prior to enrolment
Radiological evidence of pleural effusion, pneumothorax, bullous emphysema, - or pneumonitis on staging imaging
Single group
incentive spirometry
DeviceThe study will have one intervention group of patients using incentive spirometry in addition to standard of care treatment, including chemo/radiation and immunotherapy maintenance. Patients will use the incentive spirometer 10 times (10 breaths) every hour they are awake. Patients will be asked to start using the incentive spirometer as soon as they are enrolled in the study. Patients will be asked to continue to use incentive spirometry daily, including the duration of chemoradiation and up to three months post-treatment.
Incidence of Pneumonitis
Primary Endpoint: To determine the impact of incentive spirometry on the incidence of pneumonitis. Assessment Method: Number of participants diagnosed with pneumonitis, assessed using CT scan and clinical diagnostic criteria
Number of Patients with Severe Pneumonitis
Secondary Endpoint: To determine the impact of incentive spirometry on the severity of pneumonitis. Assessment Method: number of patients diagnosed with severe pneumonitis, evaluated using a standardized CTCAE grading (Common Terminology Criteria for Adverse Events)
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The Cooper Health System
Lead sponsor
The Cooper Foundation
Collaborator
