Recruiting
Phase 2

Respiratory Muscle Training

Sponsor:

Roswell Park Cancer Institute

Code:

NCT04067830

Conditions

Stage I Lung Cancer AJCC v8

Stage IA1 Lung Cancer AJCC v8

Stage IA2 Lung Cancer AJCC v8

Stage IA3 Lung Cancer AJCC v8

Stage IB Lung Cancer AJCC v8

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Best Practice

Laparoscopic Surgery

Quality-of-Life Assessment

Questionnaire Administration

Respiratory Muscle Training Device

Study Details

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.

Conditions

Stage I Lung Cancer AJCC v8

Stage IA1 Lung Cancer AJCC v8

Stage IA2 Lung Cancer AJCC v8

Stage IA3 Lung Cancer AJCC v8

Stage IB Lung Cancer AJCC v8

Study ID

NCT04067830

Start date

Mar 20, 2019

Status verified date

May, 2026

Completion date

Mar 22, 2027

Anticipated

Primary completion date

Mar 22, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Arm I (usual care)

Patients receive usual care consisting of physical therapy once weekly, receiving pre-surgical information, instruction on the use of a spirometer device, and wearing a Fitbit to track activity. Patients then undergo video-assisted thoracic surgery or laparoscopic surgery. Patients continue to track activity using the Fitbit for 3 months post-surgery.

experimental: Arm II (RMT + usual care)

Patients use a power lung device to complete 3 sets of 15 RMT exercises over 30 minutes 6 days per week over 2-4 weeks for a minimum of 12 sessions prior to surgery. Patients also receive usual care consisting of attending physical therapy once weekly, receiving pre-surgical information, instruction on the use of a spirometer device, and wearing a Fitbit to track activity. Patients then undergo video-assisted thoracic surgery or laparoscopic surgery. Patients continue to track activity using the Fitbit for 3 months post-surgery.

Interventions

Best Practice

Receive usual care

Laparoscopic Surgery

Undergo laparoscopic surgery

Quality-of-Life Assessment

Ancillary studies

Questionnaire Administration

Ancillary studies

Respiratory Muscle Training Device

Use power lung device to complete RMT

Video-Assisted Thoracic Surgery

Undergo video-assisted thoracic surgery

Primary outcome measure

  • Change in inspiratory and expiratory muscle strength [ Time Frame: Baseline up to 12 months ]
  • Change in pulmonary function and respiratory muscle endurance [ Time Frame: Baseline up to 12 months ]
  • Change in peak exercise capacity (VO2peak) [ Time Frame: Baseline up to 12 months ]

Central Contacts and Locations

Locations

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Ellis Levine, MD

716-845-3159Ellis.levine@RoswellPark.org

Principal Investigator:

Saikrishna S. Yendamuri

More Information

Sponsor

Roswell Park Cancer Institute

Last update posted

May 18, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Roswell Park Cancer Institute on 2026-05-18.