RecruitingPhase 2NCT04067830

Respiratory Muscle Training Before Surgery in Preventing Lung Complications in Patients With Stage I-IIIB Lung Cancer

Preoperative Respiratory Muscle Training to Prevent Postoperative Pulmonary Complications in Patients Undergoing Resection for Lung Cancer

Sponsor

Roswell Park Cancer Institute

Enrollment

220 participants

Start Date

Mar 20, 2019

Study Type

INTERVENTIONAL

Conditions

Stage IIIA Lung Cancer AJCC v8 Stage IIIB Lung Cancer AJCC v8 Stage II Lung Cancer AJCC v8 Stage IIB Lung Cancer AJCC v8 Stage I Lung Cancer AJCC v8 Stage IA2 Lung Cancer AJCC v8 Stage IA3 Lung Cancer AJCC v8 Stage IA1 Lung Cancer AJCC v8 Stage IB Lung Cancer AJCC v8 Stage IIA Lung Cancer AJCC v8

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 cancer who choose to undergo surgical resection often have complications after surgery such as pneumonia, unplanned intubations, difficulty breathing and reduced physical functioning, and increased medical costs and a reduced quality of life. Improving pre-surgical pulmonary health through respiratory muscle training may improve respiratory muscle strength, response to surgery, and quality of life after surgery in patients with lung cancer.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria5

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