Incentive Spirometry to Improve Outcomes in Lung Cancer Patients Undergoing Concurrent Chemotherapy and Radiation Therapy
NCT06688422 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2026-04-15
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.
Conditions
- Lung Cancer
- Pneumonitis
- Radiation-Induced Lung Injury
- Immunotherapy-Induced Pneumonitis
- Non-Small-Cell Lung Cancer (NSCLC)
Interventions
- DEVICE
-
incentive 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.
Sponsors & Collaborators
-
The Cooper Foundation
collaborator UNKNOWN -
The Cooper Health System
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-01
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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