Cancer
Conditions
Keywords
Aerobic Exercise, 19-126
Brief summary
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?
Interventions
BEHAVIORALexercise (walking)
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
OTHERplasma samples
Plasma samples will be obtained at baseline.
OTHERblood draw
fasting blood
Sponsors
Memorial Sloan Kettering Cancer Center
Weill Medical College of Cornell University
University of California, Los Angeles
City of Hope Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
For cohort 3 only. Men with histologically-confirmed localized prostate cancer undergoing active surveillance. Both patients and investigators will be fully blinded to the ctDNA status of patients during study participation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 pre-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 pre-screening clearance via PAR-Q+ Cohort 5: EDD Phase 0a * Age ≥18 yrs * Receiving investigational agent under an EDD protocol for at least 2 months. * 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 pre-screening clearance via PAR-Q+ Phase 0b * Age ≥18 yrs * Newly Within 3 months of initiating investigational agent on an EDD Service protocol * 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 pre-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 (does not apply to Cohort 5: EDD) * 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): 1. Acute myocardial infarction within 3-5 days of any planned study procedures; 2. Unstable angina 3. Uncontrolled arrhythmia causing symptoms or hemodynamic compromise 4. Recurrent syncope 5. Active endocarditis 6. Acute myocarditis or pericarditis 7. Symptomatic severe aortic stenosis 8. Uncontrolled heart failure 9. Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures 10. Thrombosis of lower extremities within 3 months of any planned study procedures 11. Suspected dissecting aneurysm 12. Uncontrolled asthma 13. Pulmonary edema 14. Respiratory failure 15. Acute non-cardiopulmonary disorders that may affect exercise performance * Room air desaturation at rest ≤ 85% (Cohorts 1 and 2 only)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of patients with variant allele frequency (VAF) | 2 years | measured by targeted CH panel in peripheral blood |
| changes in residual tumor burden (Solid tumor group) | 2 years | measured by the amount of circulating tumor DNA (ctDNA) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJessica Scott, PhD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed