Respiratory Muscle Training for Lung Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Roswell Park Cancer Institute

Disqualifiers: Metastatic cancer, Recent pulmonary embolism, Aortic aneurysm, Current pneumothorax, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether home-based breathing exercises can aid lung cancer survivors experiencing breathing difficulties and fatigue after surgery. The focus is on strengthening the breathing muscles to enhance overall fitness and quality of life. Participants will use a device to perform these exercises at varying intensities as part of a Home-Based Respiratory Muscle Training Intervention. The study seeks lung cancer survivors who underwent non-metastatic surgery and face daily breathing challenges. As an unphased trial, it offers participants the chance to contribute to research that could improve recovery and quality of life for future lung cancer survivors.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that breathing exercises at home can be safe for people with lung cancer. In a small study, cancer survivors who practiced these exercises for four weeks experienced less shortness of breath and reported no major issues or side effects. Another study found that an eight-week program of these exercises improved quality of life without causing harm. Although specific research on these exercises for cancer patients is limited, similar exercises have been well-tolerated by individuals with long-term lung diseases. This suggests that these exercises might also be safe for lung cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the home-based respiratory muscle training (RMT) for lung cancer because it offers a unique, non-invasive approach to improving respiratory function. Unlike standard treatments that typically focus on chemotherapy, radiation, or surgery, this technique involves using a Power Lung device to enhance lung strength and capacity through targeted breathing exercises. The method is accessible, as it can be performed at home, which is a game-changer for patient convenience and compliance. Additionally, it may empower patients to take an active role in their care, potentially improving their quality of life during treatment.

What evidence suggests that respiratory muscle training is effective for lung cancer survivors?

This trial will compare different intensities of respiratory muscle training (RMT) for lung cancer survivors. Studies have shown that training the muscles used for breathing, known as RMT, can improve symptoms in people with long-term breathing problems. In one study, an 8-week RMT program conducted at home improved participants' quality of life, although it did not enhance their exercise capacity. Another study focused on individuals with chronic obstructive pulmonary disease (COPD) and found that RMT improved their breathing and exercise ability. However, limited information exists on how RMT specifically affects lung cancer survivors, so results may vary. Overall, RMT appears promising for easing breathing issues and enhancing quality of life. Participants in this trial will undergo either moderate/high intensity RMT or low intensity sham RMT to evaluate its effectiveness in this population. ^{1 2 3 6 7}

Who Is on the Research Team?

Andrew D Ray

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

This trial is for stage I-III lung cancer survivors who may be experiencing breathing difficulties, fatigue, and reduced fitness post-surgery. Participants should be able to perform exercises at home and have access to the necessary equipment.

Inclusion Criteria

Willing to provide biospecimen samples for the study (blood) which will be collected in the comfort of the patient's home by a mobile phlebotomy group

Self-identify as non-Hispanic Black or White

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

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

My cancer has spread to other parts of my body (stage IV).

I don't have conditions like recent lung clots or aortic aneurysm.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in home-based respiratory muscle training (RMT) sessions using the Power Lung device, 5 days per week for 12 weeks. Blood samples are collected throughout the study.

12 weeks

Home-based/virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of fatigue, dyspnea, and quality of life.

3 months

Optional Extension

Participants may optionally participate in an additional 6 weeks of moderate/high intensity RMT sessions.

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Home-Based Respiratory Muscle Training Intervention

Trial Overview The study tests if a home-based Respiratory Muscle Training (RMT) program can alleviate symptoms like breathlessness and fatigue in lung cancer survivors. It includes using medical devices for RMT, answering questionnaires, biospecimen collection, sham intervention comparison, and electronic health record reviews.

How Is the Trial Designed?

Group I: Group I (moderate/high intensity RMT) Experimental Treatment 5 Interventions

Patients participate in home-based/virtually supervised and unsupervised moderate/high intensity RMT sessions consisting of three sets of 15 breaths using the Power Lung device over 20 to 30 minutes per session, 5 days per week for 12 weeks. Patients also undergo blood sample collection throughout the study.

Group II: Group II (low intensity sham RMT) Placebo Group 5 Interventions

Patients participate in home-based/virtually supervised and unsupervised low intensity sham RMT sessions using the Power Lung breathing device over 20 to 30 minutes per session, 5 days per week for 12 weeks. Patients also undergo blood sample collection throughout the study. Patients may optionally participate in the moderate/high intensity RMT session for 6 weeks upon study completion.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Published Research Related to This Trial

A 12-week telemedicine-based intervention combining inspiratory muscle training (IMT) and walking promotion was found to be feasible and acceptable for lung cancer survivors, with a retention rate of 79% and high participant satisfaction.

Participants in the intervention group showed significant improvements in health-related quality of life (HRQL) compared to the control group, indicating that this approach may effectively disrupt the 'dyspnea-inactivity' spiral following lung cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine-based inspiratory muscle training and walking promotion with lung cancer survivors following curative intent therapy: a parallel-group pilot randomized trial. Ha, DM., Comer, A., Dollar, B., et al.[2023]

Inspiratory muscle training (IMT) combined with exercise significantly reduced symptoms of dyspnea during daily life in breast cancer survivors, with a notable improvement in the Transitional Dyspnea Index score by +2.9 points compared to the control group.

The IMT group also showed substantial enhancements in respiratory muscle endurance and cycling endurance, with increases of +472 seconds and +428 seconds, respectively, indicating that IMT may be an effective adjunctive rehabilitation tool for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunctive Inspiratory Muscle Training During a Rehabilitation Program in Patients With Breast Cancer: An Exploratory Double-Blind, Randomized, Controlled Pilot Study. Dahhak, A., Devoogdt, N., Langer, D.[2022]

In a study of 109 elderly lung cancer patients, those who participated in enhanced recovery after surgery-based respiratory function exercises showed significant improvements in respiratory function and overall quality of life compared to those receiving only conventional care.

The exercise program also led to a lower incidence of pulmonary complications (5.26% in the exercise group vs. 21.15% in the control group), highlighting its effectiveness in promoting safer postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Enhanced Recovery After Surgery-Based Respiratory Function Exercise in Elderly Patients with Lung Cancer and its Effect on Postoperative Functional Recovery. Du, J., Wu, C., Li, A., et al.[2023]

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]

A pilot study involving 34 early-stage lung cancer patients showed that a multimodal prehabilitation program, which included nutritional supplements and exercise, is feasible and well-accepted, with high adherence rates (86% for exercise and 93% for supplements).

While the prehabilitation program successfully increased dietary intake of key nutrients like protein and omega-3 fatty acids, it did not result in significant changes in muscle characteristics, indicating the need for further research in a larger trial to assess functional and post-operative outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of multimodal prehabilitation on muscle size, myosteatosis, and dietary intake of surgical patients with lung cancer - a randomized feasibility study. Lawson, C., Ferreira, V., Carli, F., et al.[2022]

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) 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06869447

Home-Based Respiratory Muscle Training Intervention for ... This clinical trial evaluates the effects of whether breathing exercises at home can reduce symptoms and help stage I-III lung cancer survivors stay active.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11612835/

Home-Based Exercise and Self-Management After Lung ... The findings suggest that although a home-based exercise and self-management program did not improve physical function, it improves some important clinical ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1877065722000811

Home-based respiratory muscle training on quality of life ... Only an 8-week supervised home-based RMT programme was effective in improving quality of life, but not exercise tolerance, in individuals with long-term post- ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9034447/

The use of respiratory muscle training in patients with ... Little is known about clinical efficacy of RMT in cancer patients. Conflicting results have been reported regarding increases in respiratory muscle strength ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/15412555.2025.2487473

Home-Based Inspiratory Muscle Training as Stand-Alone ... The primary outcomes were inspiratory muscle performance and functional exercise capacity, while secondary outcomes included lung function, COPD-related health ...

6. wjon.org wjon.org/index.php/wjon/article/view/1781/1583

Potential Therapeutic Role of Respiratory Muscle Training in ... A small pilot, single group study has demonstrated a beneficial effect of 4-week RMT on dyspnea in cancer survivors (lung, n = 5 and breast, n = 5) [10]. Both ...

7. resmedjournal.com resmedjournal.com/article/S0954-6111(25)00029-0/fulltext

Evaluation of online videos and websites on inspiratory ... Inspiratory muscle training (IMT) is an effective rehabilitation modality for individuals with chronic lung disease. IMT can improve dyspnea, ...