Abstract 3729: The BE FIT study: feasibility of an exercise intervention on the microbiome and immune function in a high-risk cohort for lung cancer

Abstract Background/Objective: Modifiable lifestyle risk factors, including diet and exercise, have shown to be associated with reduced lung cancer risk. We previously implemented the BEWELL diet study, which assessed the effects of a black raspberry beverage on bodily inflammation and the microbiome in high-risk smokers. We recently launched the BEFIT exercise study with similar outcomes and objectives which are to: a) confirm the feasibility of an exercise intervention in high-risk smokers, and b) examine the intervention impact on the microbiome and inflammatory biomarkers. This report will describe trial progress, including participant characteristics, recruitment challenges and adherence in this ongoing study. Methods: Consenting enrollees from The Ohio State University Lung Cancer Screening Clinic (OSULCSC) were randomized to one of two arms: (a) Exercise/Behavioral Support Intervention - an ACSM-approved 12-week virtual resistance training plus aerobic program, or (b) Standard of Care - an information-only, control condition (e.g. light walking). Eligibility criteria include: ages 40-80 years, exercise<150 minutes/week, 20 pack-year smoking history and computer/internet access. Blood draws, stool samples, physical activity measures and behavior change predictors will be evaluated at baseline and intervention completion, with 1-year follow-up to assess adherence. Results: We have consented 47 out of 115 eligible participants, with 23 randomized to the intervention arm and 24 to the control arm (5 and 6 withdrew from each group, respectively). Individuals have primarily been recruited through the OSULCSC and social media ads. Our goal is to recruit 40 participants who complete the 12-week study (20 per arm). Common reasons for withdrawal include too busy, changed mind and no longer interested. Participant characteristics include mean age 64, 75% female, 89% white, 45% current smokers and mean BMI of 35 (obese). Adherence to the intervention has been high with 90% of sessions attended and no adverse events reported. Biospecimen collection and social cognitive intermediates are currently underway. Discussion: We have successfully launched the BEFIT exercise intervention study for smokers at high risk for lung cancer with high adherence and no adverse events reported. Due to initial recruiting challenges and dropout, with many being ineligible initially, we adjusted the eligibility criteria (lower age and exercise levels) and increased the study compensation. Our BEWELL study showed statistically significant improvements in the gut microbiome with a few non-significant changes in inflammation. We will assess similar outcomes in the BEFIT study and look forward to reporting these when completed. These lifestyle studies provide unique strategies for lung cancer prevention, which are greatly needed. Citation Format: Marisa A. Bittoni, Angela Lontoc, Matt Soileau, Jennifer Moon, Liliana Marin, Victoria Hockenhull, Amoni Lewis-Hughes, Daniel Spakowicz, David A. Carbone, Zachary Chaplow. The BE FIT study: feasibility of an exercise intervention on the microbiome and immune function in a high-risk cohort for lung cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 3729.