Preoperative pulmonary rehabilitation for smokers with lung nodules

Accelerated Pulmonary Rehabilitation in the Preoperative Period

This study is testing if a special exercise and support program can help current smokers with suspicious lung nodules get healthier before their lung cancer treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Vermont (other)
• Locations: 1 site (Burlington, Vermont)
• Trial ID: NCT06432972 on ClinicalTrials.gov

What this trial studies

This project involves a single-arm, non-masked intervention where participants who are current smokers with suspicious lung nodules will undergo pulmonary rehabilitation (PR) before lung cancer treatment. The study aims to assess the feasibility and acceptability of this prehabilitation approach, including smoking cessation support. Participants will be monitored for various outcomes such as fitness levels, respiratory symptoms, and surgical complications over a two-year period. The study will enroll approximately 20 participants from the University of Vermont Medical Center, focusing on those who are eligible for lung cancer treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are current smokers with a highly suspicious lung nodule and are eligible for lung cancer treatment.

Not a fit: Patients who cannot safely participate in pulmonary rehabilitation due to unstable cardiac or psychiatric conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve surgical outcomes and overall health for patients with lung cancer and COPD who smoke.

How similar studies have performed: While the specific approach of preoperative pulmonary rehabilitation for smokers with lung nodules is innovative, similar studies have shown positive outcomes in related populations.

Eligibility criteria

Inclusion Criteria:

* Age 18 years or older
* Lung nodule that is deemed highly suspicious for lung cancer based on: nodule characteristics, risk factors, CT-PET avidity, previous biopsy results, and assessment by physicians specializing in lung cancers
* Eligible for treatment
* Current cigarette smoking ≥5 cigarettes per day
* Willing to attempt smoking cessation during prehab period
* Willing to take nicotine replacement therapy (NRT) and varenicline
* Able to attend PR at UVMMC for 2, one-hour sequential sessions for a total of 16 sessions over 8 days during treatment
* Willing and able to provide informed consent; ability determined by study physician and/or LMDC treatment physicians

Exclusion Criteria:

* Unable to safely participate in PR due to unstable cardiac disease, unstable peripheral vascular disease, musculoskeletal disease that would prevent exercise, significant psychiatric or neurocognitive disease that would limit ability to exercise safely in a group setting as determined by the study physician and/or treatment physicians
* Inability to consistently attend PR during treatment
* Pregnancy, per patient self-report
* Active or recent participation in another clinical trial that, in the opinion of the investigator would impact outcomes measured in this study
* Any other condition in the opinion of the investigator/study physician and or treatment physicians that would jeopardize patient safety or integrity of research results

Where this trial is running

Burlington, Vermont

• University of Vermont Medical Center — Burlington, Vermont, United States (RECRUITING)

Study contacts

• Study coordinator: Olivia J Garrow, MS, RDN

Conditions: Chronic Obstructive Pulmonary Disease, Lung Cancer, Pulmonary Rehab