Pulmonary rehabilitation for people who survived advanced non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.