Pulmonary Rehabilitation for Lung Cancer

Overseen By Melinda Hsu, MD, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Heart failure, Coronary syndromes, 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

Duration: 8 weeks

85 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether pulmonary rehabilitation can help individuals with advanced non-small cell lung cancer (NSCLC) breathe easier and improve their daily lives. Participants will either undergo pulmonary rehabilitation for eight weeks or continue with their usual care. The trial includes interviews to identify any challenges participants or doctors encounter with this treatment. Individuals with advanced NSCLC who sometimes experience shortness of breath might be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I have to stop taking my current medications for the 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 pulmonary rehabilitation is safe for people with advanced stage non-small cell lung cancer?

Research shows that pulmonary rehabilitation (PR) is generally safe for people with lung cancer. Studies have found that this treatment can improve exercise capacity and ease breathing. For instance, one study discovered that PR reduced complications after lung surgery and lowered the risk of breathing problems.

Another study examined patients with non-small cell lung cancer and found that PR reduced breathlessness and improved mood. These findings suggest that PR is well-tolerated.

Overall, PR appears to be a safe option for managing symptoms related to lung cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about pulmonary rehabilitation (PR) for lung cancer because it offers a fresh approach beyond the usual treatments like surgery, chemotherapy, and radiation. PR focuses on improving lung function and overall fitness through tailored exercise and education, which can enhance quality of life and potentially improve treatment outcomes. Unlike traditional treatments that directly target cancer cells, this method empowers patients to strengthen their bodies and manage symptoms more effectively. By addressing physical and emotional well-being, PR could become a valuable complement to the existing standard of care.

What evidence suggests that pulmonary rehabilitation might be an effective treatment for advanced stage NSCLC?

Research has shown that pulmonary rehabilitation, which participants in this trial may receive, benefits people with lung cancer. One study found it improves exercise ability and overall health, which is important for better treatment results. Another study discovered it reduces the risk of complications after lung surgery by 60%. It also boosts muscle strength and general physical fitness. These improvements can lead to less shortness of breath and better daily functioning for people with lung cancer. ^{1 2 4 6 7}

Who Is on the Research Team?

Melinda Hsu, MD, MS

Principal Investigator

Case Comprehensive Cancer Center, University Hospitals

Are You a Good Fit for This Trial?

This trial is for people who have advanced stage non-small cell lung cancer (NSCLC) and experience shortness of breath. It's designed to see if pulmonary rehabilitation can improve their breathing, energy levels, and overall quality of life.

Inclusion Criteria

Participants must be fluent in written and spoken English

My condition hasn't worsened in the last 3 months.

I often feel out of breath or have trouble breathing.

Exclusion Criteria

Participants have evidence of clinical and/or radiographic progression

I am mentally capable of following the study's requirements.

I am at high risk for bone fractures or spine problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either eight weeks of pulmonary rehabilitation or usual care

8 weeks

Weekly visits for pulmonary rehabilitation group

Follow-up

Participants are monitored for changes in functional capacity and quality of life

4 weeks

Qualitative Interviews

Interviews conducted to assess attitudes and barriers to pulmonary rehabilitation

One-time interview between month 6 and 30

What Are the Treatments Tested in This Trial?

Interventions

• Pulmonary Rehabilitation

Trial Overview

The study tests the effects of an eight-week pulmonary rehabilitation program compared to usual care without this program. Participants are randomly assigned to one of these two options to measure the benefits of rehabilitation on lung function and fatigue in NSCLC survivors.

How Is the Trial Designed?

Group I: Pulmonary Rehabilitation (PR) Experimental Treatment 1 Intervention

Group II: Usual care Active Control 1 Intervention

Group III: Qualitative interviews Active Control 1 Intervention

A subset of PR participants, a subset of participants who decline the randomized portion of the study, and a subset of medical care providers will participate in qualitative interviews to assess attitudes and barriers to PR.

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

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 ...

Low exercise capacity can affect treatment outcomes in patients with lung cancer [5]. It increases the risk of surgical complications, hinders ...

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/erjor/11/5/00434-2025

Beyond survival: improving lung cancer rehabilitation through ...

Research indicates that rehabilitation after lung cancer surgery can significantly enhance functional exercise capacity and muscle strength, and supports ...

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.

sciencedirect.com

sciencedirect.com/science/article/pii/S1556086415330367

Increasing Physical Activity and Exercise in Lung Cancer

In summary, the evidence appears to show that exercise is safe perioperatively, functional status is improved with variable effects, and preoperative ...

7.

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.