Preoperative Respiratory Muscle Training to Prevent Postoperative Pulmonary Complications in Patients Undergoing Resection for Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Stage I Lung Cancer AJCC v8
- Sponsor
- Roswell Park Cancer Institute
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- Change in pulmonary function and respiratory muscle endurance
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Change in pulmonary function and respiratory muscle endurance
Time Frame: Baseline up to 12 months
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.
Change in inspiratory and expiratory muscle strength
Time Frame: Baseline up to 12 months
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.
Change in peak exercise capacity (VO2peak)
Time Frame: Baseline up to 12 months
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.
Secondary Outcomes
- Gene expression ribonucleic acid (RNA) extraction, reverse transcription, and real-time quantitative polymerase chain reaction (PCR) analysis(At time of surgical resection)
- Metabolic and muscle physiology marker analysis(At time of surgical resection)
- Change in fatigue level(Baseline up to 12 months)
- Change in quality of life (QoL)(Baseline up to 12 months)
- Change in QoL(Baseline up to 12 months)
- Presence or absence of pneumonia diagnoses(Up to 12 months)
- Change in sleepiness (sleep apnea)(Baseline up to 12 months)
- Change in anxiety and depression(Baseline up to 12 months)
- Change in dyspnea(Baseline up to 12 months)
- Change in sleep quality(Baseline up to 12 months)