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

Lung Carcinoma Clinical 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06445192
• Other study ID #: OSU-22194
• Secondary ID: NCI-2023-05556
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Ohio State University Comprehensive Cancer Center
• Contact: The Ohio State Comprehensive Cancer Center
• Phone: 800-293-5066
• Email: OSUCCCClinicaltrials[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 77 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Carcinoma
• Lung Neoplasms

Intervention

Other:
• Best Practice
Receive usual care

Procedure:
• Biospecimen Collection
Undergo collection of blood samples

Other:
• Exercise Counseling
Attend group counseling
• Exercise Intervention
Receive aerobic and resistance exercise intervention via telehealth
• Medical Device Usage and Evaluation
Wear Fitbit
• Physical Performance Testing
Ancillary studies
• Questionnaire Administration
Ancillary studies
• Telemedicine
Receive aerobic and resistance exercise intervention via telehealth

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients recruited to virtually-delivered exercise intervention (feasibility)	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)	Up to 1 year
Primary	Proportion of patients who achieve study adherence (feasibility) based on attendance to the exercise program sessions and biospecimens submitted.	Study adherence is defined as a) the proportion of patients attending at least 20 out of 24 sessions for the 12-week program and b) the percentage of biospecimen samples collected at the post program period (12 weeks). This study will be considered feasible if the compliance rate for both of these combined is 75% or more. Descriptive statistics will be used to examine the distribution of all patient and treatment characteristics, including compliance.	During 12-week program
Primary	Assess the number of participants with a change in inflammatory biomarkers	Will assess the effect of the intervention on inflammatory markers of C-reactive protein and IL-6 separately using linear mixed models with the biomarker serving as the outcome variable. Will also assess the changes in the biomarkers across time in each intervention group.	Baseline to post-intervention (12 weeks)
Primary	Microbe relative abundances	Will assess the effect of the intervention on the diversity and relative abundances of individual microbes. Will compare everyone's post-intervention time point to baseline in control and the exercise interventions cohorts, applying linear or generalized mixed-effects models for the diversity or individual microbes.	Baseline to post-intervention (12 weeks)

External Links

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