Pulmonary Rehabilitation for Lung Cancer

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Severe pulmonary hypertension, Exercise-induced syncope, Severe congestive heart failure, Bone metastasis, 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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a special exercise program, called pulmonary rehabilitation, can help people with lung cancer improve lung function. This improvement might enable them to undergo surgery. The study will also assess patient outcomes after surgery. Suitable candidates for this trial have lung cancer that currently cannot be operated on due to poor lung performance or overall health, but they do not have severe heart issues or certain other health problems. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

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

What prior data suggests that pulmonary rehabilitation is safe for lung cancer patients?

Research shows that pulmonary rehabilitation is generally safe for people with lung cancer. Studies have found it can enhance exercise capacity and overall quality of life without major side effects. In one study, 61% of participants experienced significant improvements, and no serious negative effects were reported. This suggests that pulmonary rehabilitation is well-tolerated by these patients. Prospective trial participants may find this information reassuring regarding the treatment's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about pulmonary rehabilitation for lung cancer because it offers a holistic approach that isn't typically part of standard treatments like surgery, chemotherapy, or radiation. Unlike these treatments, which focus directly on targeting the cancer itself, pulmonary rehabilitation aims to improve lung function and enhance overall quality of life. This method involves a series of exercises and activities over a few weeks, potentially allowing patients to breathe easier and feel better faster. By focusing on the patient's well-being and physical fitness, pulmonary rehabilitation could complement existing cancer treatments, providing a more comprehensive care plan.

What evidence suggests that pulmonary rehabilitation might be an effective treatment for lung cancer?

Research has shown that pulmonary rehabilitation, which participants in this trial will receive, can greatly benefit people with lung cancer. One study found it reduced the risk of lung problems after surgery by 60%. Other studies indicate it helps patients exercise more effectively and improves overall health. It also lowers the chances of complications during surgery and reduces breathing issues. Pulmonary rehabilitation eases breathing and can enhance mental well-being after lung surgery. These benefits make it a promising method to improve lung function and prepare for surgery. ^{2 6 7 8 9}

Who Is on the Research Team?

Vickie Shannon, BS,MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for lung cancer patients who can't have surgery due to poor lung function or other health issues but are otherwise stable. They should be able to perform some exercise without severe heart problems, not have bone metastasis, severe pulmonary hypertension, serious heart failure, or active psychiatric illness that could interfere.

Inclusion Criteria

My lung function tests show I can't have surgery for my lung tumor.

I am considered not fit for surgery due to my limited ability to perform daily activities.

Any non-pulmonary co-morbidity must be stable according to institutional guidelines

Exclusion Criteria

I do not have a psychiatric condition that could affect my treatment.

I have severe lung blood pressure or heart issues related to lung disease.

I have had fainting, chest pain, irregular heartbeat, or a significant drop in blood pressure during exercise.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pulmonary Rehabilitation

Participants undergo pulmonary rehabilitation to improve lung function, including exercise training, education, and counseling

3-4 weeks

9-12 visits (in-person)

Follow-up

Participants' health status is checked at 1 and 3 months after the last study visit or surgery, including tests and questionnaires

3 months

2 visits (in-person)

Long-term Follow-up

Research staff may contact participants by phone regarding health status, especially those who had lung surgery

30 days post-surgery

What Are the Treatments Tested in This Trial?

Interventions

• Pulmonary Rehabilitation

Trial Overview

The study is testing if a program of pulmonary rehabilitation (special exercises and therapies for the lungs) before surgery can improve lung function enough to make patients eligible for surgery and help them recover better after the operation.

How Is the Trial Designed?

Group I: Pulmonary Rehabilitation Experimental Treatment 2 Interventions

Pulmonary Rehabilitation - Rehabilitation treatment given over about 3-4 weeks. Questionnaire regarding quality-of-life that lasts about 30 minutes.

Pulmonary Rehabilitation is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Pulmonary Rehabilitation for:

• Chronic Obstructive Pulmonary Disease (COPD)
• Idiopathic Pulmonary Fibrosis (IPF)
• Interstitial Lung Diseases (ILDs)

Approved in United States as Pulmonary Rehabilitation for:

• COPD
• IPF
• ILDs
• Pulmonary Hypertension
• Cystic Fibrosis

Approved in Canada as Pulmonary Rehabilitation for:

• COPD
• IPF
• ILDs

Approved in Japan as Pulmonary Rehabilitation for:

• COPD
• IPF
• ILDs

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

Pulmonary rehabilitation is a comprehensive, non-medication intervention that has shown potential benefits for patients with chronic respiratory diseases, including those with lung cancer.

Preliminary studies indicate that pulmonary rehabilitation can improve exercise tolerance, enhance quality of life, and reduce surgical complications in lung cancer patients, suggesting it may be a valuable addition to their treatment plan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pulmonary rehabilitation in the management of patients with lung cancer]. Qiao, Y., Qiu, X., Zhou, Q.[2021]

Pulmonary rehabilitation, which includes physical training, education, and lifestyle changes, is an effective intervention for chronic respiratory disorders beyond just COPD, such as interstitial lung diseases and pulmonary hypertension.

Recent studies suggest that clinicians should consider pulmonary rehabilitation for a wide range of chronic lung conditions, including lung cancer and obesity, highlighting its versatility and potential benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pulmonary rehabilitation in respiratory disorders other than COPD : an individualized approach]. Janssens, JP., Chappuis-Gisin, É., Maragkoudakis, C., et al.[2019]

Pulmonary rehabilitation significantly enhances performance, endurance, and quality of life for patients with chronic lung disease, while also reducing hospitalizations and length of hospital stays.

Patients who are motivated to quit smoking are the most likely to benefit from pulmonary rehabilitation, making them ideal candidates for this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary rehabilitation in Switzerland. Karrer, W.[2022]

The pulmonary rehabilitation (PR) program significantly improved exercise capacity in COPD patients, with an average increase of 263.8 feet in the 6-minute walk distance (6MWD) after participation.

The program also led to a reduction in the frequency of COPD exacerbations by 0.3 events per year, indicating a positive impact on overall health, although quality-of-life improvements were mixed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary Rehabilitation: A Retrospective Study in Eastern North Carolina. Chalise, SN., Shaheen, HT., Rizwan, MZ., et al.[2019]

Pulmonary rehabilitation significantly enhances the quality of life for lung cancer patients by improving their functional capacity and endurance through tailored exercise programs and various supportive techniques.

This intervention is increasingly integrated into palliative care, helping patients manage breathlessness and maintain activity levels during chemotherapy and radiation therapy, ultimately boosting their self-efficacy and participation in family life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary Rehabilitation and Palliative Care for the Lung Cancer Patient. Tiep, B., Sun, V., Koczywas, M., et al.[2022]

Qualitative interviews with 16 patients with COPD revealed that fears about breathlessness and exercise were significant barriers to accepting pulmonary rehabilitation, while the potential to regain control over their health motivated participation.

A proposed model suggests that framing pulmonary rehabilitation as a means to regain control may help address patients' concerns and improve their willingness to engage in the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the uptake of pulmonary rehabilitation in patients with COPD: qualitative study of experiences and attitudes. Harris, D., Hayter, M., Allender, S.[2018]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11934484/

Effect of pulmonary rehabilitation on lung cancer surgery ...

The multivariate log-binomial regression revealed that PR had a reduction of 60% postoperative pulmonary complications (PPC) rate (EE = − 0.60, ...

2.

bmccancer.biomedcentral.com

bmccancer.biomedcentral.com/articles/10.1186/s12885-024-11977-5

Pulmonary rehabilitation improves exercise capacity, health ...

The aim of this study was to investigate the effects of PR on exercise capacity, HRQL, and cardiopulmonary function in patients with lung cancer.

3.

bmjopen.bmj.com

bmjopen.bmj.com/content/15/7/e091749

Pulmonary rehabilitation for patients receiving lung cancer ...

Pulmonary rehabilitation (PR) may improve the physical and psychological conditions of patients with lung cancer receiving RT, but specific evidence is lacking.

4.

publications.ersnet.org

publications.ersnet.org/content/erj/58/suppl65/pa1991

Outcomes of pulmonary rehabilitation after lung resection in ...

Pulmonary rehabilitation program applied after lung resection in patients with non-small cell lung cancer reduces dyspnea and psychological symptoms.

5.

tcr.amegroups.org

tcr.amegroups.org/article/view/64720/html

The efficacy of pulmonary rehabilitation exercise training on ...

Implementing pulmonary rehabilitation significantly reduced postoperative complications and the risk of pulmonary complications in lung cancer patients.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12306476/

Pulmonary rehabilitation for patients receiving lung cancer ...

This review mapped the evidence on PR in patients with lung cancer receiving RT for intervention characteristics and outcome assessments.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9322504/

Effectiveness of Outpatient Pulmonary Rehabilitation in ...

A minimal clinically significant change was achieved by 61% of patients. Due to its retrospective nature, there was no control group of lung ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07104630

Pulmonary Rehabilitation in Advanced Lung Cancer ...

This study is for people who have previously been diagnosed with advanced stage non-small cell lung cancer (NSCLC). Many people with advanced stage NSCLC ...

9.

sciencedirect.com

sciencedirect.com/science/article/pii/S1976131720300724

The Effects of the Respiratory Rehabilitation Program on ...

This study aims to examine the effects of the respiratory rehabilitation program on perceived self-efficacy and dyspnea in patients with lung cancer.