Pre-Surgical Respiratory Muscle Training for Lung Cancer

Overseen by Saikrishna S. Yendamuri

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Roswell Park Cancer Institute

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

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that Pre-Surgical Respiratory Muscle Training for Lung Cancer is an effective treatment?

The available research shows that Pre-Surgical Respiratory Muscle Training (RMT) can be effective for lung cancer patients. One study found that RMT, when combined with breathing exercises and early movement, improved oxygen levels in high-risk patients after lung cancer surgery. Another study indicated that RMT could help maintain the strength of breathing muscles in patients undergoing lung surgery. Additionally, a comparison of RMT with aerobic exercise training suggested that RMT might offer better post-surgery outcomes for patients having lung surgeries. These findings suggest that RMT can help improve breathing and recovery in lung cancer patients. ^{1 2 3 4 5}

What safety data exists for respiratory muscle training in lung cancer patients?

The safety of respiratory muscle training (RMT) in lung cancer patients has been evaluated in various studies. A meta-analysis suggests that perioperative RMT can improve respiratory muscle strength and physical activity in patients undergoing lung surgery. A randomized controlled trial found that postoperative inspiratory muscle training (IMT) improved oxygenation in high-risk lung cancer surgery patients, potentially reducing postoperative pulmonary complications. Additionally, a pilot study indicated that IMT with pulmonary rehabilitation might enhance respiratory muscles and exercise capacity in non-small cell lung cancer patients during radiotherapy. While these studies highlight potential benefits, they also imply that RMT is generally safe for lung cancer patients, though adherence to training can be a challenge. ^{1 2 4 6 7}

Is the treatment in the trial 'Pre-Surgical Respiratory Muscle Training for Lung Cancer' a promising treatment?

Yes, the treatment is promising. Research shows that respiratory muscle training can improve breathing strength, exercise capacity, and reduce hospital stay for lung cancer patients undergoing surgery. ^{1 2 4 8 9}

Research Team

Saikrishna S. Yendamuri

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Respiratory Muscle Training (Behavioural Intervention)

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.

Participant Groups

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+

Dr. Julia Faller

Roswell Park Cancer Institute

Chief Medical Officer since 2024

DO from an unspecified institution

Dr. Candace S. Johnson

Roswell Park Cancer Institute

Chief Executive Officer since 2015

PhD in Immunology from The Ohio State University

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Singapore pubmed.ncbi.nlm.nih.gov

The effects of inspiratory muscle training with pulmonary rehabilitation on NSCLC patients during radiation therapy: A pilot clinical study. [2023]

2. Germany 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. [2022]

3. Germany 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. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Perioperative respiratory muscle training improves respiratory muscle strength and physical activity of patients receiving lung surgery: A meta-analysis. [2022]

5. United States 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. [2023]

6. Netherlands 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. [2023]

7. England 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of respiratory muscle endurance training on wheelchair racing performance in athletes with paraplegia: a pilot study. [2008]

9. England pubmed.ncbi.nlm.nih.gov

Postoperative respiratory muscle training in addition to chest physiotherapy after pulmonary resection: A randomized controlled study. [2020]