Researching the Effect of Aerobic Exercise on Cancer
Exercise as Interception Therapy: A "Proof-of-Concept" Digitized Trail
1 other identifier
interventional
38
1 country
10
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable cancer
Started Jun 2019
Longer than P75 for not_applicable cancer
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2019
CompletedStudy Start
First participant enrolled
June 20, 2019
CompletedFirst Posted
Study publicly available on registry
June 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
July 17, 2025
July 1, 2025
7 years
June 20, 2019
July 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
number of patients with variant allele frequency (VAF)
measured by targeted CH panel in peripheral blood
2 years
changes in residual tumor burden (Solid tumor group)
measured by the amount of circulating tumor DNA (ctDNA)
2 years
Study Arms (5)
patients with clonal hematopoiesis
EXPERIMENTALExercise 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
EXPERIMENTALExercise 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
EXPERIMENTALExercise 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
EXPERIMENTALExercise 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
EXPERIMENTALParticipants will receive structured exercise therapy for 24 weeks. Participants will be followed by standard of care clinical follow-up
Interventions
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 will be obtained at baseline.
fasting blood
Eligibility Criteria
You may qualify if:
- 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:
- +31 more criteria
You may not qualify if:
- 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):
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
University of California, Los Angeles (Data or Specimen Analysis Only)
Los Angeles, California, 90095, United States
SOMALOGIC (Data or Specimen Analysis Only)
Boulder, Colorado, 80301, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
LABORATORY CORPORATION OF AMERICA HOLDINGS (Data or Specimen Analysis Only)
Burlington, North Carolina, 27215, United States
Duke University Medical Center (Data or Specimen Analysis Only)
Durham, North Carolina, 27701, United States
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica Scott, PhD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2019
First Posted
June 24, 2019
Study Start
June 20, 2019
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
July 17, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, ICF
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.