Respiratory Muscle Training Before Surgery in Preventing Lung Complications in Patients With Stage I-IIIB Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Best Practice, Laparoscopic Surgery, Quality-of-Life Assessment, Questionnaire Administration.
- Who it may be relevant to
- Registry 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. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Preoperative Respiratory Muscle Training to Prevent Postoperative Pulmonary Complications in Patients Undergoing Resection for Lung Cancer
Overview
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.
Interventions
- Other Best Practice
Receive usual care - Procedure Laparoscopic Surgery
Undergo laparoscopic surgery - Other Quality-of-Life Assessment
Ancillary studies - Other Questionnaire Administration
Ancillary studies - Device Respiratory Muscle Training Device
Use power lung device to complete RMT - Procedure Video-Assisted Thoracic Surgery
Undergo video-assisted thoracic surgery
Primary outcome measures
- Change in inspiratory and expiratory muscle strength [Time frame: Baseline up to 12 months]
- Change in pulmonary function and respiratory muscle endurance [Time frame: Baseline up to 12 months]
- Change in peak exercise capacity (VO2peak) [Time frame: Baseline up to 12 months]
Secondary outcome measures (11)
- Metabolic and muscle physiology marker analysis [Time frame: At time of surgical resection]
- Gene expression ribonucleic acid (RNA) extraction, reverse transcription, and real-time quantitative polymerase chain reaction (PCR) analysis [Time frame: At time of surgical resection]
- Change in quality of life (QoL) [Time frame: Baseline up to 12 months]
- Change in QoL [Time frame: Baseline up to 12 months]
- Change in fatigue level [Time frame: Baseline up to 12 months]
- Change in sleepiness (sleep apnea) [Time frame: Baseline up to 12 months]
- Change in sleepiness (sleep apnea) [Time frame: Baseline up to 12 months]
- Change in sleep quality [Time frame: Baseline up to 12 months]
- Change in anxiety and depression [Time frame: Baseline up to 12 months]
- Change in dyspnea [Time frame: Baseline up to 12 months]
- Presence or absence of pneumonia diagnoses [Time frame: Up to 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Roswell Park Cancer Institute — Buffalo
Identifiers
NCT: NCT04067830 · I 72818 · NCI-2019-03537 · I 72818 · R01CA222382