Evaluating the Impact of a Virtually Supervised Exercise Intervention and Group Counseling on Inflammation and the Microbiome of Smokers at High Risk for Lung Cancer, BE FIT Trial

Running, not enrolling · Not applicable

Conditions studied: Lung Carcinoma

In brief

This phase II trial evaluates how a virtually supervised exercise intervention in combination with group counseling affects inflammation and the bacterial composition (microbiome) of the gut in smokers who are at high risk for lung cancer. Physical exercise has been shown to reduce lung cancer development and to have beneficial effects on the gut microbiome and inflammation. Group counseling may promote adherence to the exercise intervention by empowering participants to exert greater control over their behavior and environment. This clinical trial may help researchers understand how exercise impacts inflammation and the microbiome in people at risk for lung cancer and whether or not exercise with counseling can improve health outcomes in high-risk individuals.

Key facts

Study ID

NCT06445192

Run by

Ohio State University Comprehensive Cancer Center

People needed

65

Starts

2023-11-03

Expected to finish

2026-12-31

Last updated by the study team

2026-02-13

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 50-77 years of age
• Current or former smoker with 20-pack year smoking history and within the last 15 years
• Fewer than 150 minutes of participation in moderate intensity physical activity each week
• All participants must be free of severe heart, respiratory (e.g. chronic obstructive pulmonary disease [COPD]), or systemic disease that would make moderate intensity exercise participation unsafe
• Willing to sign an informed consent

You may not qualify if…

• Person undergoing treatment for cancer in any form
• Person plans to enter smoking cessation or change status

Where it is running

• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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