Incentive Spirometry for Respiratory Enhancement Pilot Clinical Trial in Lung Cancer Patients Undergoing Concurrent Chemotherapy and Radiation Therapy
The Cooper Health System
Summary
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.
Description
The INSPIRE-LUNG-CRT trial is a prospective, pilot study investigating the efficacy of incentive spirometry on the incidence and severity of pneumonitis in lung cancer patients undergoing concurrent chemotherapy and radiation therapy with immunotherapy maintenance. Despite advancements in treatment modalities, pulmonary complications remain a significant challenge, often leading to diminished functional capacity and quality of life. The trial aims to establish incentive spirometry as a non-pharmacological intervention to reduce these complications, thereby improving clinical outcomes and patie…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Confirmed diagnosis of advanced non-small-cell lung cancer * Performance status (ECOG 0-1) * Eligible for concurrent chemotherapy and radiation * 18 years or older Exclusion Criteria: * 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 * Presence of active respiratory tract infection * Uncontrolled nausea and vomiting * Prior exposure to drugs such as amiodarone, bleomycin, or immun…
Interventions
- Deviceincentive spirometry
The 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.
Location
- MD Anderson Cancer Center at CooperCamden, New Jersey