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:
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
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.