Exercise and Counseling for Lung Cancer Prevention

Overseen By The Ohio State Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Must not be taking: Immunosuppressants, Steroids, Anticoagulants, others

Disqualifiers: Cancer treatment, Smoking cessation, Severe heart disease

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 20

Duration: 12 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

If you are taking immunosuppressants, bisphosphonates, steroids, anticoagulants, warfarin, apixaban, or probiotics, you will need to stop these medications to participate in the trial.

What data supports the effectiveness of the treatment Exercise and Counseling for Lung Cancer Prevention?

Research shows that exercise can be a safe and helpful addition to lung cancer care, improving physical function and quality of life. Exercise before lung cancer surgery can enhance physical and lung function, making surgery easier and reducing complications. ^{1 2 3 4 5}

Is exercise and counseling safe for humans?

Research shows that exercise interventions, including those supervised virtually or in person, are generally safe for people with cancer and other conditions. Studies report no serious exercise-related adverse events, though minor issues like muscle injuries can occur. Starting with low-intensity exercise and gradually increasing is recommended to ensure safety. ^{1 6 7 8 9}

How is the Virtually Supervised Exercise Intervention treatment different from other treatments for lung cancer prevention?

The Virtually Supervised Exercise Intervention is unique because it focuses on exercise as a preventive measure for lung cancer, offering a program that is supervised online, which can be more accessible and flexible for patients. Unlike traditional treatments that may involve medication or surgery, this approach emphasizes improving physical fitness and quality of life through guided exercise. ^{1 4 10 11 12}

Research Team

Marisa Bittoni, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for smokers at high risk of developing lung cancer. Participants will engage in a supervised exercise program and group counseling, all delivered virtually. To join, individuals must be willing to perform physical exercises, use medical devices as needed, provide biospecimens like blood or stool samples, and complete questionnaires.

Inclusion Criteria

Willing to sign an informed consent

Fewer than 60 minutes of participation in moderate intensity physical activity each week

I am between 50 and 77 years old.

Exclusion Criteria

I am currently taking medications like immunosuppressants, steroids, or blood thinners.

I am currently receiving treatment for cancer.

Person plans to enter smoking cessation or change status

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a virtually supervised aerobic and resistance exercise intervention and group counseling sessions

12 weeks

Telehealth sessions twice a week for 8 weeks, then once a week for 4 weeks

Extended Treatment

Participants continue with unsupervised exercise sessions and wear a Fitbit for monitoring

40 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Follow-up at 12 weeks and 1 year

Treatment Details

Interventions

• Group Counseling
• Virtually Supervised Exercise Intervention

Trial Overview The BE FIT Trial is testing whether virtual exercise programs combined with group counseling can reduce inflammation and positively change the gut's bacterial makeup in people at high risk for lung cancer. It involves regular physical performance tests and telemedicine check-ins.

Participant Groups

Group I: Group I (exercise intervention) Experimental Treatment 7 Interventions

Participants receive the supervised aerobic and resistance exercise intervention over 1 hour via telehealth BIW in weeks 1-8 and 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: Group II (usual care) Active Control 5 Interventions

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.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Findings from Research

Exercise interventions for lung cancer patients significantly reduce post-operative complications and improve exercise capacity, based on a systematic review of 30 studies involving a total of 6440 participants.

While exercise showed benefits in pre- and post-operative settings, health-related quality of life improvements were mostly non-significant, indicating a need for further high-quality research, especially in non-surgical populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise across the Lung Cancer Care Continuum: An Overview of Systematic Reviews. Edbrooke, L., Bowman, A., Granger, CL., et al.[2023]

Postoperative exercise interventions for surgical lung cancer patients have high to moderate-quality evidence showing they can significantly improve exercise capacity and muscle strength, which are crucial for recovery.

Preoperative exercise interventions may also enhance exercise capacity and pulmonary function, reduce the risk of postoperative complications, and shorten hospital stays, although the evidence quality is lower.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of perioperative exercise interventions on lung cancer patients: An overview of systematic reviews. Zhou, W., Woo, S., Larson, JL.[2021]

Exercise training is a safe and feasible adjunct therapy for patients with operable lung cancer, both before and after surgery, helping to improve their ability to tolerate exercise and potentially enhancing their quality of life.

For patients with inoperable lung cancer, while more research is needed, preliminary evidence indicates that carefully prescribed exercise training could also be beneficial and should be considered in their overall treatment plan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise therapy across the lung cancer continuum. Jones, LW., Eves, ND., Waner, E., et al.[2021]

Lung cancer survivors showed a preference for starting exercise programs during adjuvant treatment, especially those who had undergone lung surgery, indicating the importance of tailoring exercise timing to individual treatment experiences.

Exercise levels significantly declined after diagnosis, but engaging in exercise post-treatment was associated with improved quality of life and reduced fatigue, highlighting the potential benefits of exercise for recovery in lung cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise preferences, levels and quality of life in lung cancer survivors. Leach, HJ., Devonish, JA., Bebb, DG., et al.[2018]

Pre-surgery exercise interventions significantly improve physical and pulmonary function in lung cancer patients, which can enhance their ability to undergo surgery and reduce complications afterward.

Post-surgery exercise interventions show inconsistent results, with some studies reporting no significant effects, highlighting the need for more research on the timing and setting of exercise programs in lung cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and lung cancer surgery: A systematic review of randomized-controlled trials. Himbert, C., Klossner, N., Coletta, AM., et al.[2023]

The exercise intervention for women with stage II+ breast cancer was safe, with no serious exercise-related adverse events reported, and both low and high supervision groups showed high compliance to the exercise dosage.

Both groups experienced improvements in quality of life, physical activity, and fitness, but only the high-supervision group demonstrated significant gains in strength and self-efficacy, suggesting that more supervision may enhance certain benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomised, Comparative, Effectiveness Trial Evaluating Low- versus High-Level Supervision of an Exercise Intervention for Women with Breast Cancer: The SAFE Trial. Spence, RR., Sandler, CX., Singh, B., et al.[2023]

Supervised exercise in community settings for cancer patients is seen as a meaningful and feasible task by physical therapists and personal trainers, enhancing their confidence in promoting health during treatment.

However, challenges arise from conflicting advice given to patients about exercising during treatment, highlighting the need for better communication between oncology care and exercise professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Phys-Can study: meaningful and challenging - supervising physical exercise in a community-based setting for persons undergoing curative oncological treatment. Henriksson, A., Igelström, H., Arving, C., et al.[2022]

In a review of over 5,500 participants from 11 physical activity interventions, no serious study-related adverse events were reported, indicating a high level of safety in these exercise programs.

While minor musculoskeletal injuries were noted, the studies emphasized a 'start low and go slow' approach, suggesting that moderate-intensity physical activity is safe and effective for sedentary, chronically ill, or older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. Ory, M., Resnick, B., Jordan, PJ., et al.[2022]

The 8-week group-based physical activity program delivered via videoconferencing was feasible and well-accepted by cancer survivors, with high enrollment (61 out of 65 interested) and retention rates (86.9%).

Participants showed significant improvements in physical activity levels, muscular endurance, and quality of life after the program, indicating that this innovative approach may effectively support cancer survivors in increasing their physical activity and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Group-Based, Videoconference-Delivered Physical Activity Program for Cancer Survivors. Leach, HJ., Crisafio, ME., Howell, MJ., et al.[2023]

The LUNGEVITY trial will evaluate the effects of different exercise training types on cardiorespiratory fitness (VO2peak) and patient-reported outcomes in 160 post-operative non-small cell lung cancer patients over 16 weeks.

The study aims to determine the most effective exercise regimen (aerobic, resistance, or a combination) for improving fitness and quality of life, which could lead to new rehabilitation guidelines for lung cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The lung cancer exercise training study: a randomized trial of aerobic training, resistance training, or both in postsurgical lung cancer patients: rationale and design. Jones, LW., Eves, ND., Kraus, WE., et al.[2021]

Exercise interventions for lung cancer patients are both safe and effective, leading to improvements in physical fitness, muscle strength, and quality of life, as well as reductions in cancer-related fatigue and dyspnoea.

Prehabilitation, or exercising before treatment, has been shown to enhance recovery outcomes after surgery, highlighting the importance of individualized exercise plans throughout the cancer care journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity for people with lung cancer. Edbrooke, L., Granger, CL., Denehy, L.[2020]

Exercise can significantly benefit lung cancer patients by improving strength, endurance, and emotional well-being, regardless of the stage of their illness.

A structured recovery fitness program that includes breathing exercises, stretching, aerobic activities, and strength training is recommended to support lung cancer survivors and address their diverse needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The importance of exercise in lung cancer treatment. Michaels, C.[2020]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Exercise across the Lung Cancer Care Continuum: An Overview of Systematic Reviews. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Effects of perioperative exercise interventions on lung cancer patients: An overview of systematic reviews. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Exercise therapy across the lung cancer continuum. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Exercise preferences, levels and quality of life in lung cancer survivors. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Exercise and lung cancer surgery: A systematic review of randomized-controlled trials. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A Randomised, Comparative, Effectiveness Trial Evaluating Low- versus High-Level Supervision of an Exercise Intervention for Women with Breast Cancer: The SAFE Trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

The Phys-Can study: meaningful and challenging - supervising physical exercise in a community-based setting for persons undergoing curative oncological treatment. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A Group-Based, Videoconference-Delivered Physical Activity Program for Cancer Survivors. [2023]

10. England pubmed.ncbi.nlm.nih.gov

The lung cancer exercise training study: a randomized trial of aerobic training, resistance training, or both in postsurgical lung cancer patients: rationale and design. [2021]

11. Australia pubmed.ncbi.nlm.nih.gov

Physical activity for people with lung cancer. [2020]

12. China pubmed.ncbi.nlm.nih.gov

The importance of exercise in lung cancer treatment. [2020]