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

Roswell Park Comprehensive Cancer Center

Status and phase: Enrolling; Phase 2

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

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04067830

R01CA222382 (U.S. NIH Grant/Contract)

I 72818 (Other Identifier)

NCI-2019-03537 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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 OBJECTIVES:

I. Compare the extent of diaphragm atrophy and catabolic/anabolic pathway activation between RMT responders and non-responders evaluated for gene expression and candidate and candidate causative protein levels.

II. Determine the effect of the short-duration RMT program on health related quality-of-life measures.

III. Assess the impact of the short-duration RMT program on postoperative outcomes.

EXPLORATORY OBJECTIVES:

I. Determine the financial sustainability of a transitional home-based prehabilitation program targeting respiratory muscle weakness prior to lung resection.

II. Analysis of molecular markers to correlate with patient outcome and potentially differentiate responders from non-responders.

OUTLINE: Patients are randomized to 1 of 2 arms.

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.

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 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.

After completion of study, patients are followed up at 1, 3, 6, and 12 months.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Arm I (usual care)

Active Comparator group

Description:

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.

Treatment:

Procedure: Video-Assisted Thoracic Surgery

Other: Quality-of-Life Assessment

Other: Best Practice

Other: Questionnaire Administration

Procedure: Laparoscopic Surgery

Arm II (RMT + usual care)

Experimental group

Description:

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.

Treatment:

Procedure: Video-Assisted Thoracic Surgery

Other: Quality-of-Life Assessment

Other: Best Practice

Device: Respiratory Muscle Training Device

Other: Questionnaire Administration

Procedure: Laparoscopic Surgery