Roswell Park Cancer Institute
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.
Stage I Lung Cancer Ajc V8
Stage Ia1 Lung Cancer Ajcc v8
Stage Ia2 Lung Cancer Ajc V8
Stage Ia3 Lung Cancer Ajcc v8
Stage IB Lung Cancer Ajc V8
Stage II Lung Cancer Ajc V8
Stage Iia Lung Cancer Ajcc v8
Stage Iib Lung Cancer Ajcc v8
Stage IIIA Lung Cancer Ajc V8
Stage IIIB Lung Cancer Ajcc V8
Best Practice
Laparoscopic Surgery
Quality-of-Life Assessment
Questionnaire Administration
Respiratory Muscle Training Device
Video-Assisted Thoracic Surgery
PHASE2
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.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 220 participants |
| Masking : | NONE |
| Primary Purpose : | PREVENTION |
| Official Title : | Preoperative Respiratory Muscle Training to Prevent Postoperative Pulmonary Complications in Patients Undergoing Resection for Lung Cancer |
| Actual Study Start Date : | 2019-03-20 |
| Estimated Primary Completion Date : | 2026-03-22 |
| Estimated Study Completion Date : | 2026-03-22 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
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RECRUITING
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263