Incentive Spirometry for Respiratory Enhancement Pilot Clinical Trial in Lung Cancer Patients Undergoing Concurrent Chemotherapy and Radiation Therapy

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Confirmed diagnosis of advanced non-small-cell lung cancer

• Performance status (ECOG 0-1)

• Eligible for concurrent chemotherapy and radiation

• 18 years or older

Locations
United States
New Jersey
MD Anderson Cancer Center at Cooper
RECRUITING
Camden
Contact Information
Primary
Veli Bakalov, MD
bakalov-veli@cooperhealth.edu
856-735-6100
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 100
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: The Cooper Foundation
Leads: The Cooper Health System

This content was sourced from clinicaltrials.gov