Pulmonary rehabilitation for people who survived advanced non-small cell lung cancer
Pulmonary Rehabilitation in Advanced Lung Cancer Survivors
This research will try an eight-week pulmonary rehabilitation program to see if it helps people with advanced non-small cell lung cancer breathe easier and have more energy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 85 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT07104630 on ClinicalTrials.gov |
What this trial studies
This randomized Phase 2 study enrolls adults with stage III or IV non-small cell lung cancer who report some shortness of breath. Participants are randomly assigned to eight weeks of pulmonary rehabilitation—which includes individualized exercise training, education, and behavior support—or to usual care from their treating team. The study measures breathing symptoms, physical functioning, fatigue, and health-related quality of life before and after the intervention. The trial is conducted at University Hospitals Seidman Cancer Center/Case Comprehensive Cancer Center for clinically stable patients.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed stage III or IV NSCLC treated with palliative intent, clinically stable with no progression in the past three months, an mMRC dyspnea score ≥2, ECOG ≤3, and fluent in English.
Not a fit: Patients with active clinical or radiographic progression, those receiving curative-intent concurrent chemoradiation, people with high cardiac or fracture risk, severe cognitive impairment, or who cannot attend the in-person program or speak English are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, pulmonary rehabilitation could reduce shortness of breath and fatigue and improve physical functioning and quality of life for advanced NSCLC survivors.
How similar studies have performed: Pulmonary rehabilitation is well established to help people with COPD and small pilot studies in lung cancer survivors have suggested benefits, but large randomized trials in advanced NSCLC are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must have histologically confirmed NSCLC, Stages III or IV treated with palliative intent * Adults ≥ 18 years of age * ECOG performance status ≤ 3 * Clinical stability: defined as no clinical/radiographic progression within the last three months * Self-reported dyspnea, defined as score ≥ 2 on the modified Medical Research Council (mMRC) Dyspnea Scale * Participants must be fluent in written and spoken English Exclusion Criteria: * Participants being treated with curative intent for locally advanced NSCLC or oligometastatic NSCLC with concurrent chemotherapy and radiation will be excluded * Participants have evidence of clinical and/or radiographic progression * Mental impairment leading to inability to complete study requirements * High risk of fracture or spine instability (Mirels score ≥7 or SINS ≥7) * Any of the following cardiac exclusion criteria: * Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system * History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty or stenting within the past 6 months prior to the start of radiation therapy * Uncontrolled arrhythmias; individuals with rate-controlled atrial fibrillation for \> 1 month prior to start of radiation therapy may be eligible * Syncope * Acute myocarditis, pericarditis, or endocarditis * Acute pulmonary embolus or pulmonary infarction within the last 3 months * Acute thrombosis of lower extremities within the last 3 months * Suspected dissecting aneurysm * Pulmonary edema * Respiratory failure * Acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise
Where this trial is running
Cleveland, Ohio
- University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Melinda Hsu, MD, MS — Case Comprehensive Cancer Center, University Hospitals
- Study coordinator: Melinda Hsu, MD, MS
- Email: Melinda.hsu@uhhospitals.org
- Phone: 216-286-6505
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.