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Researching the Effect of Aerobic Exercise on Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03996239
Recruitment Status : Recruiting
First Posted : June 24, 2019
Last Update Posted : October 28, 2022
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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?

Condition or disease Intervention/treatment Phase
Cancer Behavioral: exercise (walking) Other: plasma samples Other: blood draw Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Exercise as Interception Therapy: A "Proof-of-Concept" Digitized Trail
Actual Study Start Date : June 20, 2019
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Behavioral: 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

Other: blood draw
fasting blood
Experimental: 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
 Behavioral: 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

Other: plasma samples
Plasma samples will be obtained at baseline.

Other: blood draw
fasting blood
Experimental: 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
 Behavioral: 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

Other: plasma samples
Plasma samples will be obtained at baseline.

Other: blood draw
fasting blood
Experimental: 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
 Behavioral: 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

Other: plasma samples
Plasma samples will be obtained at baseline.

Other: blood draw
fasting blood


Outcome Measures
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Primary Outcome Measures :
  1. number of patients with variant allele frequency (VAF) [ Time Frame: 2 years ]
    measured by targeted CH panel in peripheral blood

  2. changes in residual tumor burden (Solid tumor group) [ Time Frame: 2 years ]
    measured by the amount of circulating tumor DNA (ctDNA)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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+

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
  • 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996239


Contacts
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Contact: Lee Jones, PhD 646 888-8103 jonesl3@mskcc.org
Contact: Jessica Scott, PhD 646 888-8103 scottj1@mskcc.org

Locations
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United States, California
University of California, Los Angeles (Data or Specimen Analysis Only) Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Paul C Boutros, PhD    310-794-7160      
United States, Colorado
SOMALOGIC (Data or Specimen Analysis Only) Not yet recruiting
Boulder, Colorado, United States, 80301
Contact: Paul Boutros, PhD    303-625-9000      
United States, New Jersey
Memoral Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Lee Jones, PhD    646-888-8103      
Memorial Sloan Kettering Bergen Recruiting
Montvale, New Jersey, United States, 07645
Contact: Lee Jones, PhD    646-888-8103      
United States, New York
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Lee Jones, PhD    646-888-8103      
Memoral Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Lee Jones, PhD    646-888-8103      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Lee Jones, PhD    646-888-8103    jonesl3@mskcc.org   
Principal Investigator: Lee Jones, PhD         
Memorial Sloan Kettering Nassau Recruiting
Uniondale, New York, United States, 11553
Contact: Lee Jones, PhD    646-888-8103      
United States, North Carolina
LABORATORY CORPORATION OF AMERICA HOLDINGS (Data or Specimen Analysis Only) Not yet recruiting
Burlington, North Carolina, United States, 27215
Contact: Suzanne Carlisle    336-436-5760      
Duke University Medical Center (Data or Specimen Analysis Only) Not yet recruiting
Durham, North Carolina, United States, 27701
Contact: Jason Locasale, PhD    919-684-9309      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Lee Jones, PhD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03996239    
Other Study ID Numbers: 19-126
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: October 28, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Aerobic Exercise
19-126