Clinical trial · Interventional
Incentive Spirometry to Improve Outcomes in Lung Cancer Patients Undergoing Concurrent Chemotherapy and Radiation Therapy
Incentive Spirometry for Respiratory Enhancement Pilot Clinical Trial in Lung Cancer Patients Undergoing Concurrent Chemotherapy and Radiation Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Immunotherapy-Induced Pneumonitis | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Non-Small-Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
| Pneumonitis | — | UNRESOLVED | — |
| Radiation-Induced Lung Injury | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| incentive spirometry | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention Arm
- description
- 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.
- interventionNames
- Device: incentive spirometry
Primary outcomes (1)
- measure
- Incidence of Pneumonitis
- timeFrame
- 12 months
- description
- 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
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDVansteenkiste 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
- BACKGROUNDZhong 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