An interventional study of incentive spirometry in Lung Cancer, Pneumonitis and Radiation-Induced Lung Injury, sponsored by The Cooper Health System. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by The Cooper Health System · Not applicable, Interventional, and Supportive care
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.
The INSPIRE-LUNG-CRT trial is a prospective, pilot study investigating the efficacy of incentive spirometry on the incidence and severity of pneumonitis in lung cancer patients undergoing concurrent chemotherapy and radiation therapy with immunotherapy maintenance. Despite advancements in treatment modalities, pulmonary complications remain a significant challenge, often leading to diminished functional capacity and quality of life. The trial aims to establish incentive spirometry as a non-pharmacological intervention to reduce these complications, thereby improving clinical outcomes and patient well-being. Lung cancer treatments are frequently associated with pulmonary toxicities, such as radiation-induced pneumonitis and fibrosis, immunotherapy induced pneumonitis, significantly impacting patient outcomes. Incentive spirometry, a device that encourages deep breathing and lung expansion, has shown promise in postoperative settings but is underutilized in oncology.
The pilot, prospective trial will enroll 100 patients diagnosed with advanced, unresectable non-small-cell lung cancer, candidates will receive concurrent chemotherapy and radiation therapy. Inclusion criteria includes a confirmed diagnosis of advanced non-small-cell lung cancer, good performance status (ECOG 0-1), and eligibility for concurrent chemotherapy and radiation. Exclusion criteria includes previous lung or thoracic surgery, enrollment in another pulmonary intervention trial, home oxygen usage prior to enrollment, radiological evidence of pleural effusion, pneumothorax, bullous emphysema, or pneumonitis, active respiratory tract infection, uncontrolled nausea and vomiting, prior exposure to certain drugs, and inability to give informed consent.
The primary endpoint is to determine the impact of incentive spirometry on the incidence and severity of pneumonitis. Secondary endpoints include evaluating the impact on overall survival and patients\' quality of life using the EORTC QLQ-C30 questionnaire. Patients will use the incentive spirometer 10 times (10 breaths) every hour while awake, starting as soon as they are enrolled in the study. The use will continue daily during chemoradiation and up to three months post-treatment. The study duration for each subject is approximately six months, including the use of incentive spirometry during the concurrent chemoRT phase (6-8 weeks) and continued use for up to three months post-treatment.
Inclusion Criteria:
Exclusion Criteria:
Interventions 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 undergo procedures for diagnostic and treatment purposes. Standard procedures for lung cancer patients includes, but is not limited to, routine diagnostic tests such as imaging (CT scans, PET scans, MRI scan), blood tests, and pulmonary function tests (PFTs), diagnostic biopsies. 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 monitoring adherence to the spirometry regimen through patient logs and periodic check-ins.
Duration of Participation. The study duration for each subject is approximately 12 months, including: Use of incentive spirometry during the concurrent chemoRT phase (approximately 6-8 weeks). Continued use of the spirometer for up to three months post-treatment. Quality of life assessments and pulmonary function tests at 3-, 6- and 12 months post-treatment.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 100 is above the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →The Cooper Health System is the lead sponsor of 64 studies on the registry; 15 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Compared within Carcinoma, Non-Small-Cell Lung, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lung Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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
Time frame: 12 months
Number of Patients with Severe Pneumonitis
Secondary Endpoint: To determine the impact of incentive spirometry on the severity of pneumonitis. Assessment Method: number of patients diagnosed with severe pneumonitis, evaluated using a standardized CTCAE grading (Common Terminology Criteria for Adverse Events)
Time frame: 12 months
Plan to share: No — We do not plan to share individual participant data (IPD) due to privacy concerns and the need to protect the confidentiality of participants. Additionally, the data collected during this study includes sensitive health information that could potentially identify participants, even when de-identified. Given the nature of the data and ethical considerations, we have decided not to make IPD available to other researchers.
Started Dec 2024 (actual). Primary completion is estimated for Dec 2026, 24 months after the start.
Of 343 non-industry interventional studies with no phase under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 98. This study's planned 24 months is below that.
Counting every sponsor, half of 359 studies reached it within 51 months; a quarter within 26 and three quarters within 97.
How these figures are worked out, and which studies are left out of them.
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