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Researching the Effect of Aerobic Exercise on Cancer

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ClinicalTrials.gov Identifier: NCT03996239
Recruitment Status : Recruiting
First Posted : June 24, 2019
Last Update Posted : May 27, 2021
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE June 20, 2019
First Posted Date  ICMJE June 24, 2019
Last Update Posted Date May 27, 2021
Actual Study Start Date  ICMJE June 20, 2019
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
  • number of patients with variant allele frequency (VAF) [ Time Frame: 2 years ]
    measured by targeted CH panel in peripheral blood
  • changes in residual tumor burden (Solid tumor group) [ Time Frame: 2 years ]
    measured by the amount of circulating tumor DNA (ctDNA)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Researching the Effect of Aerobic Exercise on Cancer
Official Title  ICMJE Exercise as Interception Therapy: A "Proof-of-Concept" Digitized Trail
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • Behavioral: exercise (walking)
    • Other: blood draw
  • 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
    Interventions:
    • Behavioral: exercise (walking)
    • Other: plasma samples
    • Other: blood draw
  • 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
    Interventions:
    • Behavioral: exercise (walking)
    • Other: plasma samples
    • Other: blood draw
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 19, 2020)
48
Original Estimated Enrollment  ICMJE
 (submitted: June 21, 2019)
36
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 30 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
  • Any other current diagnosis of invasive cancer or hematologic cancer of any kind
  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lee Jones, PhD 646 888-8103 jonesl3@mskcc.org
Contact: Jessica Scott, PhD 646 888-8103 scottj1@mskcc.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03996239
Other Study ID Numbers  ICMJE 19-126
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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)
Supporting Materials: Informed Consent Form (ICF)
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lee Jones, PhD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP