Exercise and counseling program for smokers at high risk for lung cancer
The BE FIT Study: Feasibility of an Exercise Intervention on Microbiome and Immune Function in a High-Risk Cohort for Lung Cancer
This study is testing whether a combination of online exercise and group counseling can help smokers at high risk for lung cancer improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 55 Years to 77 Years |
| Sex | All |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06445192 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effects of a virtually supervised exercise intervention combined with group counseling on inflammation and gut microbiome in smokers at high risk for lung cancer. Participants are randomized into two groups: one receiving the exercise intervention and counseling, and the other receiving usual care. The intervention includes telehealth sessions for aerobic and resistance exercises, along with group counseling, while monitoring health biomarkers and microbiome changes. The study aims to assess the feasibility and preliminary efficacy of this multi-component approach in improving health outcomes for high-risk individuals.
Who should consider this trial
Good fit: Ideal candidates are current or former smokers aged 50-77 with a significant smoking history and low physical activity levels.
Not a fit: Patients currently undergoing cancer treatment or those on specific medications that affect exercise safety may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could reduce inflammation and improve gut health, potentially lowering lung cancer risk in smokers.
How similar studies have performed: Other studies have shown positive outcomes with exercise interventions in cancer prevention, suggesting this approach may be promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 50-77 years of age * Current or former smoker with 20-pack year smoking history and within the last 15 years * Fewer than 60 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 Exclusion Criteria: * Person is on a regimen of the following medications: immunosuppressants, bisphosphonates, steroids, anticoagulants, warfarin, apixaban, probiotics * Person undergoing treatment for cancer in any form * Person plans to enter smoking cessation or change status
Where this trial is running
Columbus, Ohio
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Marisa Bittoni, PhD — Ohio State University Comprehensive Cancer Center
- Study coordinator: The Ohio State Comprehensive Cancer Center
- Email: OSUCCCClinicaltrials@osumc.edu
- Phone: 800-293-5066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.