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

NCT04067830 | Recruiting Phase 2 FDA Device

• 3 other identifiers: I 72818NCI-2019-03537R01CA222382
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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; Stage II Lung Cancer AJCC v8; Stage IIA Lung Cancer AJCC v8; Stage IIB Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8

Outcome Measures

Primary Outcomes (3)

• Change in inspiratory and expiratory muscle strength

  Will be treated as a continuous variable and will be summarized by treatment group and time-point using the mean, median, standard deviation, and the appropriate percentiles. The effectiveness of the respiratory muscle training (RMT) program on each respiratory outcome will be assessed by comparing the preoperative change between groups using an analysis of covariance (ANCOVA) model, with an adjustment for the pretreatment levels. For each outcome, the preoperative change (T1-T0) will be modeled as a function of treatment group (RMT versus usual care) and pre-treatment levels. A one-sided Wald type-test about coefficient for treatment group will evaluate whether the RMT program had a beneficial impact on the given respiratory outcome. All model assumptions will be verified graphically using quantile-quantile and residual plots. Transformations will be applied as appropriate.

  Baseline up to 12 months

• Change in pulmonary function and respiratory muscle endurance

  Will be treated as a continuous variable and will be summarized by treatment group and time-point using the mean, median, standard deviation, and the appropriate percentiles. The effectiveness of the RMT program on each respiratory outcome will be assessed by comparing the preoperative change between groups using an ANCOVA model, with an adjustment for the pretreatment levels. For each outcome, the preoperative change (T1-T0) will be modeled as a function of treatment group (RMT versus usual care) and pre-treatment levels. A one-sided Wald type-test about coefficient for treatment group will evaluate whether the RMT program had a beneficial impact on the given respiratory outcome. All model assumptions will be verified graphically using quantile-quantile and residual plots. Transformations will be applied as appropriate.

  Baseline up to 12 months

• Change in peak exercise capacity (VO2peak)

  Will be treated as a continuous variable and will be summarized by treatment group and time-point using the mean, median, standard deviation, and the appropriate percentiles. The effectiveness of the RMT program on each respiratory outcome will be assessed by comparing the preoperative change between groups using an ANCOVA model, with an adjustment for the pretreatment levels. For each outcome, the preoperative change (T1-T0) will be modeled as a function of treatment group (RMT versus usual care) and pre-treatment levels. A one-sided Wald type-test about coefficient for treatment group will evaluate whether the RMT program had a beneficial impact on the given respiratory outcome. All model assumptions will be verified graphically using quantile-quantile and residual plots. Transformations will be applied as appropriate.

  Baseline up to 12 months

Secondary Outcomes (11)

• Metabolic and muscle physiology marker analysis

  At time of surgical resection

• Gene expression ribonucleic acid (RNA) extraction, reverse transcription, and real-time quantitative polymerase chain reaction (PCR) analysis

  At time of surgical resection

• Change in quality of life (QoL)

  Baseline up to 12 months

• Change in QoL

  Baseline up to 12 months

• Change in fatigue level

  Baseline up to 12 months

Other Outcomes (5)

• Total hospital length of stay (LOS)

  Up to 12 months

• Total intensive care unit LOS

  Up to 12 months

• Pre-operative LOS

  From date of admission to the date of surgery

Study Arms (2)

Arm I (usual care)

ACTIVE COMPARATOR

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.

Other: Best Practice; Procedure: Laparoscopic Surgery; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Video-Assisted Thoracic Surgery

Arm II (RMT + usual care)

EXPERIMENTAL

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.

Other: Best Practice; Procedure: Laparoscopic Surgery; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Device: Respiratory Muscle Training Device; Procedure: Video-Assisted Thoracic Surgery

Interventions

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Arm I (usual care); Arm II (RMT + usual care)

Laparoscopic Surgery PROCEDURE

Undergo laparoscopic surgery

Also known as: laparoscopic-assisted resection, laparoscopy-assisted surgery

Arm I (usual care); Arm II (RMT + usual care)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (usual care); Arm II (RMT + usual care)

Questionnaire Administration OTHER

Ancillary studies

Arm I (usual care); Arm II (RMT + usual care)

Respiratory Muscle Training Device DEVICE

Use power lung device to complete RMT

Arm II (RMT + usual care)

Video-Assisted Thoracic Surgery PROCEDURE

Undergo video-assisted thoracic surgery

Also known as: VATS

Arm I (usual care); Arm II (RMT + usual care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Laparoscopy; Thoracic Surgery, Video-Assisted

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracoscopy; Video-Assisted Surgery; Thoracic Surgical Procedures

Study Officials

• Saikrishna S Yendamuri

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: August 28, 2019
• Study Start: March 20, 2019
• Primary Completion (Estimated): March 22, 2027
• Study Completion (Estimated): March 22, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-09

Locations

US (1)