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Researching the Effect of Aerobic Exercise on Cancer

Memorial Sloan Kettering Cancer Center (MSK) logo

Memorial Sloan Kettering Cancer Center (MSK)

Status

Enrolling

Conditions

Cancer

Treatments

Behavioral: exercise (walking)
Other: plasma samples
Other: blood draw

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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?

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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+

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 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 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)

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 5 patient groups

patients with clonal hematopoiesis
Experimental group
Description:
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
Treatment:
Other: blood draw
Behavioral: exercise (walking)
post treatment patients with breast or colorectal cancer
Experimental group
Description:
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
Treatment:
Other: blood draw
Other: plasma samples
Behavioral: exercise (walking)
men with localized prostate cancer undergoing active surveillance
Experimental group
Description:
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
Treatment:
Other: blood draw
Other: plasma samples
Behavioral: exercise (walking)
Individuals with Lynch Syndrome
Experimental group
Description:
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
Treatment:
Other: blood draw
Other: plasma samples
Behavioral: exercise (walking)
Individuals enrolled on Early Drug Development (EDD) trials
Experimental group
Description:
Participants will receive structured exercise therapy for 24 weeks. Participants will be followed by standard of care clinical follow-up
Treatment:
Behavioral: exercise (walking)

Trial contacts and locations

10

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Central trial contact

Lee Jones, PhD; Jessica Scott, PhD

Data sourced from clinicaltrials.gov

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