Status:
RECRUITING
Respiratory Muscle Training Before Surgery in Preventing Lung Complications in Patients With Stage I-IIIB Lung Cancer
Lead Sponsor:
Roswell Park Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Stage I Lung Cancer AJCC v8
Stage IA1 Lung Cancer AJCC v8
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial studies how well respiratory muscle training before surgery works in preventing lung complications after surgery in patients with stage I-IIIB lung cancer. Patients with lung cance...
Detailed Description
PRIMARY OBJECTIVES: I. Assess the impact of a short-duration respiratory muscle training (RMT) program on respiratory muscle strength in patients undergoing resection for lung cancer. SECONDARY OBJE...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 22 2027
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT04067830
Start Date
March 20 2019
End Date
March 22 2027
Last Update
September 5 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263