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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 : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: patients with clonal hematopoiesis
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
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. 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
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.




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)



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 anthracycline treatment
    • Prior left-sided breast and/or chest wall radiotherapy
    • Currently receiving or previously received androgen deprivation therapy Prior bone marrow transplant
    • History of smoking
  • 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
  • Adequate FFPE tumor block / slides from surgery
  • 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

Exclusion Criteria:

  • Concurrent use of any form of antitumor therapy (endocrine therapy and anti-HER2 antibodies allowed for breast patients)
  • 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 exercise:

    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%

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: Neil Iyengar, MD 646 888-8103 iyengarn@mskcc.org
Contact: Lee Jones, PhD 646 888-8103

Locations
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United States, New Jersey
Memoral Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Neil Iyengar, MD    646-888-8103      
Memorial Sloan Kettering Bergen Not yet recruiting
Montvale, New Jersey, United States, 07645
Contact: Neil Iyengar, MD    646-888-8103      
United States, New York
Memorial Sloan Kettering Cancer Center @ Commack Recruiting
Commack, New York, United States, 11725
Contact: Neil Iyengar, MD    646-888-8103      
Memoral Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Neil Iyengar, MD    646-888-8103      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Neil Iyengar, MD    646-888-8103      
Contact: Lee Jones, PhD    646-888-8103      
Principal Investigator: Neil Iyengar, MD         
Memorial Sloan Kettering Nassau Recruiting
Uniondale, New York, United States, 11553
Contact: Neil Iyengar, MD    646-888-8103      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Neil Iyengar, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03996239     History of Changes
Other Study ID Numbers: 19-126
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
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