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

75 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical research study is to see if pulmonary rehabilitation can improve patients' lung function, which would increase their chances of becoming eligible for surgery. The health of pulmonary rehabilitation participants after surgery will also be examined.

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 data supports the effectiveness of the treatment Pulmonary Rehabilitation for lung cancer?

Pulmonary rehabilitation, a non-drug treatment, has shown promise in improving exercise tolerance, quality of life, and surgical outcomes for lung cancer patients. It is well-established for helping those with chronic respiratory diseases, like COPD, and early studies suggest similar benefits for lung cancer patients. ^{1 2 3 4 5}

Is pulmonary rehabilitation safe for humans?

Pulmonary rehabilitation is generally considered safe for humans, as studies have shown it to be a feasible and beneficial intervention for patients with lung cancer and other chronic respiratory diseases, improving exercise capacity and quality of life. ^{1 6 7 8 9}

How is the treatment Pulmonary Rehabilitation unique for lung cancer patients?

Pulmonary Rehabilitation is unique for lung cancer patients because it is a non-medication treatment that focuses on improving exercise tolerance, quality of life, and surgical outcomes through a combination of exercise programs, breathing techniques, and lifestyle changes. Unlike traditional drug therapies, it helps patients manage symptoms and enhance their ability to participate in daily activities and family life. ^{1 2 10 11 12}

Research Team

Vickie Shannon, BS,MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. China pubmed.ncbi.nlm.nih.gov

[Pulmonary rehabilitation in the management of patients with lung cancer]. [2021]

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

Pulmonary Rehabilitation in Lung Cancer. [2019]

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

Preoperative and postoperative pulmonary rehabilitation in lung cancer patients. [2008]

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

Pulmonary Rehabilitation: A Retrospective Study in Eastern North Carolina. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Improving the uptake of pulmonary rehabilitation in patients with COPD: qualitative study of experiences and attitudes. [2018]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Pulmonary Rehabilitation Programmes Within Three Days of Hospitalization for Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-Analysis. [2022]

7. Singapore pubmed.ncbi.nlm.nih.gov

Feasibility of an eight-week outpatient-based pulmonary rehabilitation program for advanced lung cancer patients undergoing cytotoxic chemotherapy in Korea. [2019]

8. France pubmed.ncbi.nlm.nih.gov

[Pulmonary rehabilitation after lung resection for tumor - a feasibility study]. [2013]

9. Switzerland pubmed.ncbi.nlm.nih.gov

[Pulmonary rehabilitation: a multidisciplinary and comprehensive intervention]. [2009]

10. Switzerland pubmed.ncbi.nlm.nih.gov

[Pulmonary rehabilitation in respiratory disorders other than COPD : an individualized approach]. [2019]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Pulmonary rehabilitation in Switzerland. [2022]

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

Pulmonary Rehabilitation and Palliative Care for the Lung Cancer Patient. [2022]