Clinical trial NCT04067830: Respiratory Muscle Training Before Surgery in Preventing Lung Complications in Patients With Stage I-IIIB Lung Cancer
Official title: Preoperative Respiratory Muscle Training to Prevent Postoperative Pulmonary Complications in Patients Undergoing Resection for Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
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
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-08-28
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed 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.

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

Primary outcomes:
measure: Change in inspiratory and expiratory muscle strength
timeFrame: Baseline up to 12 months
measure: Change in pulmonary function and respiratory muscle endurance
timeFrame: Baseline up to 12 months
measure: Change in peak exercise capacity (VO2peak)
timeFrame: Baseline up to 12 months
Secondary outcomes:
measure: Metabolic and muscle physiology marker analysis
timeFrame: At time of surgical resection
measure: Gene expression ribonucleic acid (RNA) extraction, reverse transcription, and real-time quantitative polymerase chain reaction (PCR) analysis
timeFrame: At time of surgical resection
measure: Change in quality of life (QoL)
timeFrame: Baseline up to 12 months
measure: Change in QoL
timeFrame: Baseline up to 12 months
measure: Change in fatigue level
timeFrame: Baseline up to 12 months
measure: Change in sleepiness (sleep apnea)
timeFrame: Baseline up to 12 months
measure: Change in sleepiness (sleep apnea)
timeFrame: Baseline up to 12 months
measure: Change in sleep quality
timeFrame: Baseline up to 12 months
measure: Change in anxiety and depression
timeFrame: Baseline up to 12 months
measure: Change in dyspnea
timeFrame: Baseline up to 12 months
measure: Presence or absence of pneumonia diagnoses
timeFrame: Up to 12 months
Other outcomes:
measure: Total hospital length of stay (LOS)
timeFrame: Up to 12 months
measure: Total intensive care unit LOS
timeFrame: Up to 12 months
measure: Pre-operative LOS
timeFrame: From date of admission to the date of surgery
measure: Lung infection rates
timeFrame: Up to 12 months
measure: Identified molecular marker analysis
timeFrame: Up to 1 month post-surgery
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Saikrishna S Yendamuri
role: PRINCIPAL_INVESTIGATOR
References: