Pulmonary Rehabilitation in Advanced Lung Cancer Survivors
Recruiting · NCT07104630 · Interventional (participants receive a specific treatment) · Lead sponsor: Case Comprehensive Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This study is for people who have previously been diagnosed with advanced stage non-small cell lung cancer (NSCLC). Many people with advanced stage NSCLC have trouble breathing and feel tired. People may be eligible for this study if they have advanced stage NSCLC and feel short of breath some of the time. NSCLC survivors may also experience things like fatigue and a lower quality of life. Pulmonary rehabilitation is a type of supportive treatment that may improve these symptoms. This study has two parts. The first part is a randomized trial where half of the participants receive eight weeks of pulmonary rehabilitation. The other half of participants do not do pulmonary rehabilitation and instead receive the treatment that their doctors would normally recommend. The purpose of this part of the research study is to understand if pulmonary rehabilitation can help people with advanced stage NSCLC have better functioning and less shortness of breath. The other part of the research study is an interview study. The purpose of doing interviews is to understand any challenges or obstacles that people with advanced stage NSCLC may have regarding pulmonary rehabilitation, as well as oncology care providers have with their participants going to pulmonary rehabilitation.
Who can take part
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 it is running
1 location listed across 1 US state.
- University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center - Cleveland, Ohio, United States