Researching the Effect of Aerobic Exercise on Cancer
Status
Conditions
Treatments
Details and patient eligibility
About
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?
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Cohort 1: CH
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CH called by MSK practices as documented by an MSK physician
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Age ≥18 yrs
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Completion of all anticancer therapy
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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)
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Performing less than 150 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluated by self-report
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Willingness to comply with all study-related procedures
Cohort 2: Solid Tumor
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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)
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Age ≥ 18 yrs
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Performing less than 150 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluated by self-report
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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+
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 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 screening clearance via PAR-Q+
Exclusion criteria
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Concurrent use of any form of antitumor therapy (endocrine therapy and anti-HER2 antibodies allowed)
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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)
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Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation.
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Mental impairment leading to inability to cooperate
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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
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Room air desaturation at rest ≤ 85% (Cohorts 1 and 2 only)
Trial design
Primary purpose
Allocation
Interventional model
Masking
60 participants in 5 patient groups
Trial contacts and locations
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Central trial contact
Lee Jones, PhD; Jessica Scott, PhD
Data sourced from clinicaltrials.gov
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