Pre-Surgical Respiratory Muscle Training for Lung Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Roswell Park Cancer Institute

Disqualifiers: Ischemic heart disease, Congestive heart failure, Cardiac arrhythmias, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

220 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether respiratory muscle training before lung cancer surgery can prevent post-surgery breathing problems like pneumonia. The study compares usual care with additional exercises using a power lung device to strengthen breathing muscles. It aims to improve recovery and quality of life for patients with stage I to IIIB lung cancer planning to undergo surgery. Suitable participants have documented lung cancer and are scheduled for specific types of lung surgery. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to advance lung cancer care.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial investigators for guidance.

What prior data suggests that respiratory muscle training is safe for lung cancer patients?

Research shows that respiratory muscle training (RMT) might be safe for people with lung cancer. A small study found that four weeks of RMT helped cancer survivors breathe more easily. Another study found that breathing exercises greatly reduced the risk of pneumonia after surgery.

Although information on RMT for cancer patients is limited, available data suggests it is generally well-tolerated. This trial is in an early stage, aiming to test the safety and effectiveness of RMT. Treatments typically reach this phase after demonstrating some safety in earlier tests. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Respiratory Muscle Training (RMT) for lung cancer patients because it focuses on strengthening respiratory muscles before surgery, which is different from the usual care. Unlike standard treatments that mostly involve post-surgical rehabilitation, RMT proactively prepares the lungs, potentially improving surgical outcomes. The use of a power lung device for RMT offers a hands-on, exercise-based approach that could enhance lung capacity and recovery. This method could offer a significant advantage by addressing respiratory health before the stress of surgery, which is why there’s a buzz around its potential benefits.

What evidence suggests that respiratory muscle training is effective for preventing lung complications after surgery in lung cancer patients?

Research shows that exercising breathing muscles before surgery can aid lung cancer patients in recovering more effectively. In this trial, one group will receive Respiratory Muscle Training (RMT) alongside usual care. Studies have found that this training strengthens these muscles and helps individuals remain active after lung surgery. Some research also suggests it can reduce the risk of post-surgery lung issues, such as pneumonia or breathing difficulties. This method is believed to enhance the body's ability to manage surgery and improve quality of life afterward. Overall, evidence supports its potential to make surgery safer and recovery smoother for lung cancer patients. ^{6 7 8 9 10}

Who Is on the Research Team?

Saikrishna S. Yendamuri

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

This trial is for patients with stage I-IIIB lung cancer, who can understand English and are set to have curative surgery (VATS or laparoscopic). It includes those who've had chemoradiotherapy. Excluded are pregnant women, those too frail, with poor performance status (ECOG > 2), or serious heart issues.

Inclusion Criteria

I may or may not have had chemoradiotherapy before surgery.

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

I am scheduled for or considering minimally invasive surgery for lung cancer.

Exclusion Criteria

My doctor considers me medically frail or I am mostly bedridden.

Any condition which in the investigator's opinion deems the participant an unsuitable candidate to participate in this study

I am currently pregnant or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Respiratory Muscle Training

Participants use a power lung device to complete 3 sets of 15 RMT exercises over 30 minutes, 6 days per week for 2-4 weeks prior to surgery

2-4 weeks

Surgery

Participants undergo video-assisted thoracic surgery or laparoscopic surgery

Postoperative Monitoring

Participants continue to track activity using a Fitbit for 3 months post-surgery

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Respiratory Muscle Training

Trial Overview

The study tests if training the respiratory muscles before surgery can prevent complications like pneumonia and breathing problems after lung cancer surgery. It involves exercises using a device, quality-of-life assessments, and questionnaires.

How Is the Trial Designed?

Group I: Arm II (RMT + usual care) Experimental Treatment 6 Interventions

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.

Group II: Arm I (usual care) Active Control 5 Interventions

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.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Inspiratory muscle training (IMT) combined with pulmonary rehabilitation (PR) significantly improved respiratory muscle strength and exercise capacity in 20 patients with non-small cell lung cancer (NSCLC) undergoing radiotherapy, with no reported adverse events.

Key improvements were observed in maximum inspiratory muscle pressure, 6-minute walk test distance, cycle endurance test performance, and knee strength measurements after 4 weeks of training, indicating the potential benefits of IMT with PR for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of inspiratory muscle training with pulmonary rehabilitation on NSCLC patients during radiation therapy: A pilot clinical study. Do, J., Lee, SH., Kim, SA., et al.[2023]

The new inspiratory muscle training and positive expiratory pressure (IMT/PEP) device improved maximal expiratory pressure in older men and showed non-inferiority compared to the Threshold IMT device, confirming its efficacy for respiratory muscle training.

Both home-based and center-based training protocols had high adherence rates (91-99%), suggesting that with proper education, home-based training can be effective for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a new respiratory muscle training device in community-dwelling elderly men: an open-label, randomized, non-inferiority trial. Kim, SH., Shin, MJ., Lee, JM., et al.[2022]

In a pilot study involving 12 competitive wheelchair racing athletes, respiratory muscle endurance training (RMET) significantly improved the athletes' 10-km time-trial performance, with times decreasing from 27.1 minutes to 24.1 minutes after 30 sessions of training.

The training group also showed a significant increase in respiratory muscle endurance, while the control group did not experience any improvement, indicating that RMET can enhance both respiratory function and exercise performance in wheelchair athletes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of respiratory muscle endurance training on wheelchair racing performance in athletes with paraplegia: a pilot study. Mueller, G., Perret, C., Hopman, MT.[2008]

Inspiratory muscle training (IMT) is feasible and shows potential effectiveness in reducing breathlessness and improving quality of life in lung cancer patients, as demonstrated in a pilot study with 46 participants over 12 weeks.

Significant improvements were observed in various outcome measures, including distress from breathlessness, coping ability, and emotional function, suggesting that IMT could be a beneficial intervention for managing symptoms in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of resistance inspiratory muscle training in the management of breathlessness in patients with thoracic malignancies: a feasibility randomised trial. Molassiotis, A., Charalambous, A., Taylor, P., et al.[2018]

Preoperative respiratory muscle training (RMT) significantly reduces postoperative pulmonary complications (PPC), pneumonia, and respiratory failure (PRF) in patients undergoing thoracic surgeries, showing comparable efficacy to preoperative aerobic exercise training (AET) based on a meta-analysis of 25 studies involving 2070 patients.

Both RMT and AET also lead to a similar reduction in hospital length of stay (HLOS) by approximately 1.7 days, indicating that either training method can be beneficial in improving postoperative outcomes, especially in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-Operative Outcomes of Pre-Thoracic Surgery Respiratory Muscle Training vs Aerobic Exercise Training: A Systematic Review and Network Meta-analysis. Kunadharaju, R., Saradna, A., Ray, A., et al.[2023]

Perioperative respiratory muscle training (RMT) significantly improved postoperative respiratory muscle strength, as indicated by an increase in maximal inspiratory pressure (MIP) by 8.13 cmH2O in a meta-analysis of 7 studies involving 240 participants.

RMT also enhanced postoperative physical activity levels, suggesting it may be beneficial for recovery in patients undergoing lung surgery, although further research with larger sample sizes is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative respiratory muscle training improves respiratory muscle strength and physical activity of patients receiving lung surgery: A meta-analysis. Yang, MX., Wang, J., Zhang, X., et al.[2022]

In a study of 40 patients undergoing pulmonary resection, those who received preoperative respiratory muscle training (RMT) in addition to chest physiotherapy showed significant improvements in respiratory muscle strength and exercise capacity compared to those who only received chest physiotherapy.

Patients in the RMT group had a shorter hospital stay (9.1 days) compared to the control group (12.9 days), indicating that RMT may enhance recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative respiratory muscle training in addition to chest physiotherapy after pulmonary resection: A randomized controlled study. Taşkin, H., Telli Atalay, O., Yuncu, G., et al.[2020]

Preoperative respiratory muscle training (RMT) significantly reduced the incidence of postoperative pulmonary complications (PPCs) and pneumonia in patients undergoing open cardiac surgery, with a risk reduction of 49% for PPCs and 56% for pneumonia based on a systematic review of 8 trials involving 696 participants.

RMT also led to a shorter hospital stay by an average of 1.7 days and improved respiratory muscle strength, as indicated by higher maximal inspiratory pressure values, making it a beneficial intervention for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative respiratory muscle training reduces the risk of pulmonary complications and the length of hospital stay after cardiac surgery: a systematic review. Cursino de Moura, JF., Oliveira, CB., Coelho Figueira Freire, AP., et al.[2023]

Two weeks of inspiratory muscle training (IMT) did not preserve respiratory muscle strength in high-risk patients undergoing lung cancer surgery, as measured by maximal inspiratory and expiratory pressures, but it did improve oxygen saturation levels postoperatively.

The incidence of pneumonia was similar between the IMT group and the control group, suggesting that IMT did not significantly reduce the risk of postoperative pulmonary complications, although it showed a trend towards better oxygenation on days 3 and 4 after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative inspiratory muscle training in addition to breathing exercises and early mobilization improves oxygenation in high-risk patients after lung cancer surgery: a randomized controlled trial. Brocki, BC., Andreasen, JJ., Langer, D., et al.[2022]

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