Can a walking routine alter cancer biomarkers? new trial investigates

NCT ID NCT03996239

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 21, 2026 · Last updated Aug 06, 2026 · Updated 3 times

Summary

This study explores whether regular aerobic exercise, specifically walking about 300 minutes per week, can change certain biomarkers in the blood that are linked to cancer risk. Participants are adults who have completed all cancer therapy and have either clonal hematopoiesis (a blood condition) or a solid tumor with residual disease. The trial uses a home-based, digitally monitored exercise program to see if exercise can intercept cancer progression.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
aerobic exercise (walking)
What this could lead to
If it works, this could show that exercise can reduce cancer-related biomarkers, pointing toward a non-drug way to lower cancer risk.
What could go wrong
This is a small early-stage proof-of-concept trial, so results may not be conclusive or apply to everyone. Exercise adherence may vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

38 people

The number who actually took part.

Started

Jun 2019

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 pre-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 pre-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 pre-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 pre-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)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Duke University Medical Center (Data or Specimen Analysis Only)

    Durham, North Carolina, 27701, United States

  • LABORATORY CORPORATION OF AMERICA HOLDINGS (Data or Specimen Analysis Only)

    Burlington, North Carolina, 27215, United States

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604, United States

  • SOMALOGIC (Data or Specimen Analysis Only)

    Boulder, Colorado, 80301, United States

  • University of California, Los Angeles (Data or Specimen Analysis Only)

    Los Angeles, California, 90095, United States

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