Incentive Spirometry to Improve Outcomes in Lung Cancer Patients Undergoing Concurrent Chemotherapy and Radiation Therapy

Part of paid clinical trials in Camden, New Jersey.

Sponsor
The Cooper Health System
Study ID
NCT06688422
Status
Recruiting

Conditions

  • Immunotherapy-Induced Pneumonitis
  • Lung Cancer
  • Non-Small-Cell Lung Cancer (NSCLC)
  • Pneumonitis
  • Radiation-Induced Lung Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • incentive spirometry — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Dec 1, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Intervention Arm
    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. For research purposes, patients will be asked to use incentive spirometry. 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. Patients will be asked to to complete QoL assessments.

Primary Outcome Measure

Incidence of Pneumonitis [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer Center at CooperCamdenNew Jersey08103
Veli Bakalov, MD
8567356100

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