Researching the Effect of Aerobic Exercise on Cancer

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03996239
Collaborator
(none)
37
10
4
47.4
3.7
0.1

Study Details

Study Description

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
  • Behavioral: exercise (walking)
  • Other: plasma samples
  • Other: blood draw
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
37 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 :
Jun 20, 2019
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

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

Primary Outcome Measures

  1. number of patients with variant allele frequency (VAF) [2 years]

    measured by targeted CH panel in peripheral blood

  2. changes in residual tumor burden (Solid tumor group) [2 years]

    measured by the amount of circulating tumor DNA (ctDNA)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 University of California, Los Angeles (Data or Specimen Analysis Only) Los Angeles California United States 90095
2 SOMALOGIC (Data or Specimen Analysis Only) Boulder Colorado United States 80301
3 Memoral Sloan Kettering Monmouth Middletown New Jersey United States 07748
4 Memorial Sloan Kettering Bergen Montvale New Jersey United States 07645
5 Memorial Sloan Kettering Commack Commack New York United States 11725
6 Memoral Sloan Kettering Westchester Harrison New York United States 10604
7 Memorial Sloan Kettering Cancer Center New York New York United States 10065
8 Memorial Sloan Kettering Nassau Uniondale New York United States 11553
9 LABORATORY CORPORATION OF AMERICA HOLDINGS (Data or Specimen Analysis Only) Burlington North Carolina United States 27215
10 Duke University Medical Center (Data or Specimen Analysis Only) Durham North Carolina United States 27701

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Lee Jones, PhD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT03996239
Other Study ID Numbers:
  • 19-126
First Posted:
Jun 24, 2019
Last Update Posted:
Apr 5, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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

Study Results

No Results Posted as of Apr 5, 2022