Researching the Effect of Aerobic Exercise on Cancer

NCT ID: NCT03996239

Last Updated: 2025-07-17

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-20

Study Completion Date

2026-06-30

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?

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
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.

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

Group Type EXPERIMENTAL

exercise (walking)

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

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

Group Type EXPERIMENTAL

exercise (walking)

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

Plasma samples will be obtained at baseline.

blood draw

Intervention Type OTHER

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

Group Type EXPERIMENTAL

exercise (walking)

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

Plasma samples will be obtained at baseline.

blood draw

Intervention Type OTHER

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

Group Type EXPERIMENTAL

exercise (walking)

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

Plasma samples will be obtained at baseline.

blood draw

Intervention Type OTHER

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

Group Type EXPERIMENTAL

exercise (walking)

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

plasma samples

Plasma samples will be obtained at baseline.

Intervention Type OTHER

blood draw

fasting blood

Intervention Type OTHER

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 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

SOMALOGIC (Data or Specimen Analysis Only)

Boulder, Colorado, United States

Site Status

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Site Status

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Site Status

Memorial Sloan Kettering Commack

Commack, New York, United States

Site Status

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Site Status

LABORATORY CORPORATION OF AMERICA HOLDINGS (Data or Specimen Analysis Only)

Burlington, North Carolina, United States

Site Status

Duke University Medical Center (Data or Specimen Analysis Only)

Durham, North Carolina, United States

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 41124991 (View on PubMed)

Related Links

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http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

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19-126

Identifier Type: -

Identifier Source: org_study_id

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