Respiratory muscle training before lung cancer surgery
Preoperative Respiratory Muscle Training to Prevent Postoperative Pulmonary Complications in Patients Undergoing Resection for Lung Cancer
This study is testing if breathing exercises can help lung cancer patients recover better and avoid complications after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Roswell Park Cancer Institute Academic / other |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT04067830 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates the effectiveness of respiratory muscle training (RMT) in preventing lung complications after surgery in patients with stage I-IIIB lung cancer. Participants are randomized into two groups: one receiving usual care and the other incorporating RMT exercises using a specialized device. The study aims to assess improvements in respiratory muscle strength, postoperative outcomes, and quality of life, while also exploring molecular markers that may predict patient responses to the training. The trial includes a comprehensive evaluation of health-related quality of life and financial sustainability of the prehabilitation program.
Who should consider this trial
Good fit: Ideal candidates are patients with documented stage I-IIIb lung cancer who are scheduled for surgical resection.
Not a fit: Patients with significant cardiac issues or overall medical frailty may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative lung complications and improve recovery and quality of life for lung cancer patients.
How similar studies have performed: Other studies have shown promise in using prehabilitation techniques to improve surgical outcomes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Documented stage I-IIIb lung cancer or is undergoing surgery for diagnosis * Participant is able to speak, read, and comprehend English * Participant must be undergoing or is anticipated to either video-assisted thoracic surgery (VATS or robotic surgery) or laparoscopic surgery for curative intent lung resection * Patients with or without neoadjuvant chemoradiotherapy (CRT) prior to surgery will be included * Ability to follow written and verbal instructions * Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: * Documented ischemic heart disease; congestive heart failure or; significant cardiac arrhythmias that would exclude them from having surgery * Overall medical frailty (clinician discretion) or ECOG \> 2 * Pregnant or nursing female participants * Unwilling or unable to follow protocol requirements * Any condition which in the investigator's opinion deems the participant an unsuitable candidate to participate in this study
Where this trial is running
Buffalo, New York
- Roswell Park Cancer Institute — Buffalo, New York, United States (Recruiting)
Study contacts
- Principal investigator: Saikrishna S Yendamuri — Roswell Park Cancer Institute
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.