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

Clinical Trial ID: NCT04067830

Description

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.

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.


Criteria

Inclusion Criteria: - Documented stage I-IIIb lung cancer - Participant is able to speak, read, and comprehend English - Participant must be undergoing either video-assisted thoracic surgery (VATS) or laparoscopic surgery for curative intent lung resection - Have the following pulmonary function values: - Forced expiratory volume in 1 second (FEV1) < 60% (% predicted) and/or, - Diffusion capacity of the lung for carbon monoxide (DLCO) < 60% of predicted - Note: Patients with moderate-to-severe airflow obstruction will be chosen because they are at the greatest risk for complications and also demonstrate the greatest benefits associated with RMT - Patients with or without neoadjuvant chemoradiotherapy (CRT) prior to surgery will be included - Cognitive ability to follow written and verbal instructions - Participant must be available for a minimum of 2 weeks prior to scheduled surgical resection - Participant or legal representative 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 - Overall medical frailty (clinician discretion) - 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

  • Start Date

    2019-01-22

  • Last Updated

    2019-08-21

  • Sponsor

    National Cancer Institute (NCI)

  • Condition Name

    Stage IIIB Lung Cancer AJCC v8

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