Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
38 participants
INTERVENTIONAL
2019-06-20
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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patients with clonal hematopoiesis
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
exercise (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
blood draw
fasting blood
post treatment patients with breast or colorectal cancer
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
exercise (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
plasma samples
Plasma samples will be obtained at baseline.
blood draw
fasting blood
men with localized prostate cancer undergoing active surveillance
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
exercise (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
plasma samples
Plasma samples will be obtained at baseline.
blood draw
fasting blood
Individuals with Lynch Syndrome
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
exercise (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
plasma samples
Plasma samples will be obtained at baseline.
blood draw
fasting blood
Individuals enrolled on Early Drug Development (EDD) trials
Participants will receive structured exercise therapy for 24 weeks. Participants will be followed by standard of care clinical follow-up
exercise (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
Interventions
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exercise (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
plasma samples
Plasma samples will be obtained at baseline.
blood draw
fasting blood
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Weill Medical College of Cornell University
OTHER
University of California, Los Angeles
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jessica Scott, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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University of California, Los Angeles (Data or Specimen Analysis Only)
Los Angeles, California, United States
SOMALOGIC (Data or Specimen Analysis Only)
Boulder, Colorado, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States
Memorial Sloan Kettering Commack
Commack, New York, United States
Memorial Sloan Kettering Westchester
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Nassau
Uniondale, 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
Countries
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References
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Scott JM, Tsai BL, Stewart C, Eng SE, White JR, Bolton KL, Vaz-Luis I, Havas J, Di Meglio A, Martin AL, Boyault S, Wang R, Micol JB, Diaz LA Jr, Boutros PC, Jones LW. Impact of Exercise on Clonal Hematopoiesis. JACC Adv. 2025 Oct 21;4(11 Pt 1):102260. doi: 10.1016/j.jacadv.2025.102260. Online ahead of print.
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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19-126
Identifier Type: -
Identifier Source: org_study_id
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