Researching the Effect of Aerobic Exercise on Cancer

Not Applicable

Recruiting

Conditions: Cancer

Interventions: Behavioral: exercise (walking)
Other: plasma samples
Other: blood draw

Registration Number: NCT03996239

Lead Sponsor: Memorial Sloan Kettering Cancer Center

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?

Detailed Description: Not available

Recruitment & Eligibility

Status: RECRUITING

Sex: All

Target Recruitment: 52

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)

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients with clonal hematopoiesis	exercise (walking)	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
post treatment patients with breast or colorectal cancer	exercise (walking)	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
men with localized prostate cancer undergoing active surveillance	exercise (walking)	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
Individuals with Lynch Syndrome	blood draw	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
patients with clonal hematopoiesis	blood draw	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
post treatment patients with breast or colorectal cancer	plasma samples	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
men with localized prostate cancer undergoing active surveillance	plasma samples	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
Individuals with Lynch Syndrome	plasma samples	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
post treatment patients with breast or colorectal cancer	blood draw	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
men with localized prostate cancer undergoing active surveillance	blood draw	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
Individuals with Lynch Syndrome	exercise (walking)	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
Individuals enrolled on Early Drug Development (EDD) trials	exercise (walking)	Participants will receive structured exercise therapy for 24 weeks. Participants will be followed by standard of care clinical follow-up

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (10): University of California, Los Angeles (Data or Specimen Analysis Only)
🇺🇸
Los Angeles, California, United States
Memorial Sloan Kettering Monmouth
🇺🇸
Middletown, New Jersey, United States
Memorial Sloan Kettering Nassau
🇺🇸
Uniondale, New York, United States
SOMALOGIC (Data or Specimen Analysis Only)
🇺🇸
Boulder, Colorado, United States
Memorial Sloan Kettering Commack
🇺🇸
Commack, New York, United States
Memorial Sloan Kettering Westchester
🇺🇸
Harrison, New York, United States
Memorial Sloan Kettering Bergen
🇺🇸
Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Center
🇺🇸
New York, New York, United States
LABORATORY CORPORATION OF AMERICA HOLDINGS (Data or Specimen Analysis Only)
🇺🇸
Burlington, North Carolina, United States
Duke University Medical Center (Data or Specimen Analysis Only)
🇺🇸
Durham, North Carolina, United States

Researching the Effect of Aerobic Exercise on Cancer

Recruitment & Eligibility

Study & Design

Trial Locations

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