Preoperative Respiratory Muscle Training to Prevent Postoperative Pulmonary Complications in Patients Undergoing Resection for Lung Cancer

Who is this study for? Patients undergoing resection for lung cancer
Status: Recruiting
Location: See location...
Intervention Type: Other, Device, Procedure
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Roswell Park Cancer Institute
RECRUITING
Buffalo
Time Frame
Start Date: 2019-03-20
Estimated Completion Date: 2027-03-22
Participants
Target number of participants: 220
Treatments
Active_comparator: 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.
Experimental: 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 attending 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.
Related Therapeutic Areas
Sponsors
Leads: Roswell Park Cancer Institute
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov