Researching the Effect of Aerobic Exercise on Cancer

Study Overview
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Brief Summary
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This study is being done to answer the following question: Will aerobic exercise (exercise that stimulates and strengthens the heart and lungs, and improves the body's use of oxygen) change the biomarkers (signs of disease) found in the blood?

Official Title
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Exercise as Interception Therapy: A Proof-of-Concept Digitized Trail

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: exercise (walking)
* Other: plasma samples
* Other: blood draw


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cohort 1: CH CH called by MSK practices as documented by an MSK physician Age ≥18 yrs Completion of all anticancer therapy High risk of cardiovascular disease defined by presence of at least one of the following: Age ≥60 Prior treatment with chemotherapy Prior left-sided breast and/or chest wall radiotherapy Currently receiving or previously received androgen deprivation therapy Prior bone marrow transplant History of smoking Currently treated for one or more cardiovascular risk factors (i.e., hypertension, diabetes, hyperlipidemia) Performing less than 150 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluated by self-report Willingness to comply with all study-related procedures Cohort 2: Solid Tumor Patients at risk of harboring circulating tumor DNA as defined by one of the following: Histologically confirmed stage III (i.e., high risk of recurrence) colorectal cancer within 2 years of completion of all adjuvant therapy. Histologically confirmed stage III breast cancer with residual disease after neoadjuvant therapy and within 12 months of completing (neo)adjuvant chemotherapy Patients with metastatic breast cancer and radiographic stable disease or NED for ≥6 months and not currently receiving chemotherapy (endocrine therapy and anti-HER2 antibodies allowed) Age ≥ 18 yrs Performing less than 150 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluated by self-report Willingness to comply with all study-related procedures Cohort 3: Active Surveillance Men with histologically confirmed localized prostate cancer undergoing active surveillance Age ≥ 18 yrs Performing less than 15 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluated by self-report Willingness to comply with all study-related procedures Cleared for exercise participation as per screening clearance via PAR-Q+ Cohort 4: Lynch Syndrome Age ≥18 yrs Hereditary colorectal cancer syndrome, specifically Lynch syndrome, defined by the presence of a deleterious germline mutation in the MLH1, MSH2, MSH6, PMS2 or EPCAM genes Have a portion of the distal colon or rectosigmoid intact to enable collection of normal mucosa biopsies Performing less than 150 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluated by self-report Willingness to comply with all study-related procedures Cleared for exercise participation as per screening clearance via PAR-Q+ Exclusion Criteria: Concurrent use of any form of antitumor therapy (endocrine therapy and anti-HER2 antibodies allowed) Enrollment onto any other interventional investigational study except interventions determined by the PI not to confound study outcomes Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation. Mental impairment leading to inability to cooperate Any of the following contraindications to cardiopulmonary exercise testing (Cohorts 1 and 2 only): Acute myocardial infarction within 3-5 days of any planned study procedures; Unstable angina Uncontrolled arrhythmia causing symptoms or hemodynamic compromise Recurrent syncope Active endocarditis Acute myocarditis or pericarditis Symptomatic severe aortic stenosis Uncontrolled heart failure Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures Thrombosis of lower extremities within 3 months of any planned study procedures Suspected dissecting aneurysm Uncontrolled asthma Pulmonary edema Respiratory failure Acute non-cardiopulmonary disorders that may affect exercise performance Room air desaturation at rest ≤ 85% (Cohorts 1 and 2 only)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with clonal hematopoiesis<br>Exercise treatment will consist of individualized walking delivered up to 5 times weekly. Patients in all cohorts will receive one dose of exercise (i.e.,  300 mins/wk following a non-linear dosing schedule) in both cohorts. Patients will have the option to receive exercise treatment at MSK or at their residence. Home-based exercise will be implemented and monitored using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service | Behavioral: exercise (walking)<br>* Exercise treatment will consist of individualized walking delivered up to 5 times weekly. This trial will evaluate one dose of exercise (i.e.,  300 mins/wk following a non-linear dosing schedule) in both cohorts. Patients will have the option to receive exercise treatment at MSK or at their residence. Home-based exercise will be implemented and monitored using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service<br>Other: blood draw<br>* fasting blood<br>|
| Experimental: post treatment patients with breast or colorectal cancer<br>Exercise treatment will consist of individualized walking delivered up to 5 times weekly. Patients in all cohorts will receive one dose of exercise (i.e.,  300 mins/wk following a non-linear dosing schedule) in both cohorts. Patients will have the option to receive exercise treatment at MSK or at their residence. Home-based exercise will be implemented and monitored using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service | Behavioral: exercise (walking)<br>* Exercise treatment will consist of individualized walking delivered up to 5 times weekly. This trial will evaluate one dose of exercise (i.e.,  300 mins/wk following a non-linear dosing schedule) in both cohorts. Patients will have the option to receive exercise treatment at MSK or at their residence. Home-based exercise will be implemented and monitored using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service<br>Other: plasma samples<br>* Plasma samples will be obtained at baseline.<br>Other: blood draw<br>* fasting blood<br>|
| Experimental: men with localized prostate cancer undergoing active surveillance<br>Exercise treatment will consist of individualized walking delivered up to 5 times weekly. Patients in all cohorts will receive one dose of exercise (i.e.,  300 mins/wk following a non-linear dosing schedule) in both cohorts. Patients will have the option to receive exercise treatment at MSK or at their residence. Home-based exercise will be implemented and monitored using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service | Behavioral: exercise (walking)<br>* Exercise treatment will consist of individualized walking delivered up to 5 times weekly. This trial will evaluate one dose of exercise (i.e.,  300 mins/wk following a non-linear dosing schedule) in both cohorts. Patients will have the option to receive exercise treatment at MSK or at their residence. Home-based exercise will be implemented and monitored using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service<br>Other: plasma samples<br>* Plasma samples will be obtained at baseline.<br>Other: blood draw<br>* fasting blood<br>|
| Experimental: Individuals with Lynch Syndrome<br>Exercise treatment will consist of individualized walking delivered up to 5 times weekly. Patients in all cohorts will receive one dose of exercise (i.e.,  300 mins/wk following a non-linear dosing schedule) in both cohorts. Patients will have the option to receive exercise treatment at MSK or at their residence. Home-based exercise will be implemented and monitored using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service | Behavioral: exercise (walking)<br>* Exercise treatment will consist of individualized walking delivered up to 5 times weekly. This trial will evaluate one dose of exercise (i.e.,  300 mins/wk following a non-linear dosing schedule) in both cohorts. Patients will have the option to receive exercise treatment at MSK or at their residence. Home-based exercise will be implemented and monitored using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service<br>Other: plasma samples<br>* Plasma samples will be obtained at baseline.<br>Other: blood draw<br>* fasting blood<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with variant allele frequency (VAF) | measured by targeted CH panel in peripheral blood | 2 years | 
| changes in residual tumor burden (Solid tumor group) | measured by the amount of circulating tumor DNA (ctDNA) | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aerobic Exercise, 19-126