Recruiting

Incentive Spirometry

Sponsor:

The Cooper Health System

Code:

NCT06688422

Conditions

Lung Cancer

Pneumonitis

Radiation-Induced Lung Injury

Immunotherapy-Induced Pneumonitis

Non-Small-Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

incentive spirometry

Study Details

Brief 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)

Study ID

NCT06688422

Start date

Dec 1, 2024

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 immunotherapy
  • Inability or unwillingness of individual to give written informed consent

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

  • Incidence of Pneumonitis [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Veli Bakalov, MD

856-735-6100bakalov-veli@cooperhealth.edu

Locations

MD Anderson Cancer Center at Cooper

Recruiting

Camden, New Jersey, United States, 08103

Contacts

Veli Bakalov, MD

8567356100bakalov-veli@cooperhealth.edu

More Information

Sponsor

The Cooper Health System

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Keywords

  • Incentive Spirometry
  • Chemotherapy
  • Radiation Therapy
  • Quality of Life (QoL)
  • Respiratory Complications
  • Advanced Lung Cancer
  • Concurrent Chemoradiotherapy
  • Pulmonary Toxicity
  • Immunotherapy Maintenance
  • Lung Function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cooper Health System on 2026-04-15.