Clinical trial NCT06445192: 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
Official title: The BE FIT Study: Feasibility of an Exercise Intervention on Microbiome and Immune Function in a High-Risk Cohort for Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Carcinoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 88
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: PRIMARY OBJECTIVES:

I. To evaluate the feasibility and preliminary efficacy of establishing a multi-component virtually-delivered exercise intervention trial with longitudinal biomarker and microbiome collection in the Ohio State University Lung Cancer Screening Clinic (OSULCSC).

II. To determine the impact of the multi-component virtually-delivered exercise intervention on the microbiome and inflammatory biomarkers.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I: Participants receive the supervised aerobic and resistance exercise intervention over 1 hour via telehealth twice a week (BIW) in weeks 1-8 and once a week (QW) in weeks 9-12 and then continue with unsupervised exercise sessions BIW in weeks 13-52. Participants also attend group counseling sessions over 1 hour QW in weeks 1-8 and bi-weekly in weeks 9-12. Participants also wear a Fitbit throughout the trial and undergo collection of blood samples at baseline and follow up.

GROUP II: Participants receive usual care consisting of education on standard recommendations for physical activity, the benefits of exercise, and an example of a light walking program. Participants also wear a Fitbit throughout the trial and undergo collection of blood samples at baseline and follow up.

After completion of study intervention, participants are followed up at 12 weeks and 1 year.

Eligibility 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 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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of patients recruited to virtually-delivered exercise intervention (feasibility)
timeFrame: Up to 1 year
measure: Proportion of patients who achieve study adherence (feasibility) based on attendance to the exercise program sessions and biospecimens submitted.
timeFrame: During 12-week program
measure: Assess the number of participants with a change in inflammatory biomarkers
timeFrame: Baseline to post-intervention (12 weeks)
measure: Microbe relative abundances
timeFrame: Baseline to post-intervention (12 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Marisa Bittoni, PhD
role: PRINCIPAL_INVESTIGATOR
References: