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

NCT06688422 | Recruiting FDA Device

• 1 other identifier: 24-135
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of Pneumonitis

  Primary Endpoint: To determine the impact of incentive spirometry on the incidence of pneumonitis. Assessment Method: Number of participants diagnosed with pneumonitis, assessed using CT scan and clinical diagnostic criteria

  12 months

Secondary Outcomes (1)

• Number of Patients with Severe Pneumonitis

  12 months

Study Arms (1)

Intervention Arm

EXPERIMENTAL

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.

Device: incentive spirometry

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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of advanced non-small-cell lung cancer
• Performance status (ECOG 0-1)
• Eligible for concurrent chemotherapy and radiation
• years or older

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cooper Health System: lead
• The Cooper Foundation: collaborator

Study Sites (1)

MD Anderson Cancer Center at Cooper

Camden, New Jersey, 08103, United States

RECRUITING

Related Publications (2)

• Vansteenkiste JF, Naidoo J, Faivre-Finn C, Ozguroglu M, Villegas A, Daniel D, Murakami S, Hui R, Lee KH, Cho BC, Kubota K, Broadhurst H, Wadsworth C, Newton M, Thiyagarajah P, Antonia SJ. Symptomatic Pneumonitis With Durvalumab After Concurrent Chemoradiotherapy in Unresectable Stage III NSCLC. JTO Clin Res Rep. 2024 Jan 18;5(3):100638. doi: 10.1016/j.jtocrr.2024.100638. eCollection 2024 Mar.

  PMID: 38455595 BACKGROUND

• Zhong L, Altan M, Shannon VR, Sheshadri A. Immune-Related Adverse Events: Pneumonitis. Adv Exp Med Biol. 2020;1244:255-269. doi: 10.1007/978-3-030-41008-7_13.

  PMID: 32301020 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Pneumonia; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Infections; Carcinoma, Bronchogenic; Bronchial Neoplasms

Central Study Contacts

Veli Bakalov, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Cooper Medical School of Rowan University

Study Record Dates

• First Submitted: November 9, 2024
• First Posted: November 14, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)