NCT04067830 Respiratory Muscle Training Before Surgery in Preventing Lung Complications in Patients With Stage I-IIIB Lung Cancer
| NCT ID | NCT04067830 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Roswell Park Cancer Institute |
| Condition | Stage I Lung Cancer AJCC v8 |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2019-03-20 |
| Primary Completion | 2027-03-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 220 participants in total. It began in 2019-03-20 with a primary completion date of 2027-03-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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
Contact & Investigator
Ellis Levine, MD
PRINCIPAL INVESTIGATOR
Roswell Park Cancer Institute
Frequently Asked Questions
Who can join the NCT04067830 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stage I Lung Cancer AJCC v8. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04067830 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04067830 currently recruiting?
Yes, NCT04067830 is actively recruiting participants. Visit ClinicalTrials.gov or contact Roswell Park Cancer Institute to inquire about joining.
Where is the NCT04067830 trial being conducted?
This trial is being conducted at Buffalo, United States.
Who is sponsoring the NCT04067830 clinical trial?
NCT04067830 is sponsored by Roswell Park Cancer Institute. The principal investigator is Ellis Levine, MD at Roswell Park Cancer Institute. The trial plans to enroll 220 participants.
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