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NCT04589468Recruiting

Researching the Effect of Exercise on Cancer

Phase 1a/b Trial of Exercise as Interception Therapy for Primary High-Risk Cancer

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

Researchers think that exercise may be able to prevent cancer from coming back by lowering ctDNA levels. The purpose of this study is to explore how aerobic exercise (exercise that stimulates and strengthens the heart and lungs and improves the body's use of oxygen) can reduce the level of ctDNA found in the blood. During the study, the highest level of exercise that is practical, is safe, and has positive effects on the body that may prevent the return of cancer (including a decrease in ctDNA levels) will be found. Each level of exercise tested will be a certain number of minutes each week. Once the best level of exercise is found, it will be tested further in a new group of participants. All participants in this study will have been previously treated for breast, prostate, or colorectal cancer.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
51 (estimated)
First submitted
5 Oct 2020
Start date
12 Oct 2026
Primary completion date
13 Feb 2028
Lead sponsor
City of Hope Medical Center
NCT number
NCT04589468

What you commit to

  • Study type: Interventional
  • Planned participants: 51
  • From 12 Oct 2026 to the primary completion date, 13 Feb 2028
  • 9 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Any other current diagnosis of invasive cancer of any kind
  • Distant metastatic malignancy 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

Other

  • Enrollment onto any other interventional investigational study except interventions determined by the PI not to confound study outcomes

Who the study is looking for

  • Postsurgical diagnosis of patients with primary solid tumors at high-risk of relapse as defined by one of the following:
    • ° High-risk primary solid tumor (e.g., colorectal, ovarian, non-small cell lung cancer) (colorectal cancer only for Phase 1a)
  • Stage 3 or
  • ctDNA positive
    • ° High-risk breast cancer
  • Residual invasive disease in the breast or the lymph nodes following completion of neoadjuvant chemotherapy (NACT),
  • Estrogen receptor (ER), and/or progesterone receptor (PR) positive and HER2 negative,
  • CPS-EG score ≥ 3,
  • CPS-EG score ≥2 w ith ypN+, or
  • Recurrence score ≥ 25
  • No evidence of disease
  • Age ≥ 18
  • Interval of ≥ 1 month but ≤ 2 years following completion of all definitive adjuvant therapy
  • Non-exercising (i.e., \< 30 minutes of moderate and \< 20 mins of vigorous exercise/wk), as assessed by remote activity and heart rate tracking for a 7-day period prior to study entry)
    • ° If ≥ 30 minutes but less than 45 minutes of moderate exercise/week, or if ≥ 20 minutes but less than 30 minutes of vigorous exercise/week, patients may be eligible, at the discretion of the PI.
  • Cleared for exercise participation as per screening clearance via PAR-Q+
  • Willingness to comply with all study-related procedures

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Coordinator of this site? Confirm its status
Basking RidgeUnited StatesActive, not recruiting
Memorial Sloan Kettering Commack (Limited protocol activities)
Coordinator of this site? Confirm its status
CommackUnited StatesActive, not recruiting
City of Hope Medical Center
Coordinator of this site? Confirm its status
DurateUnited StatesRecruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Coordinator of this site? Confirm its status
HarrisonUnited StatesActive, not recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Coordinator of this site? Confirm its status
MiddletownUnited StatesActive, not recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Coordinator of this site? Confirm its status
MontvaleUnited StatesActive, not recruiting
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesActive, not recruiting
Natera, Inc. (Data or Specimen Analysis Only)
Coordinator of this site? Confirm its status
San CarlosUnited StatesNot yet recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Coordinator of this site? Confirm its status
UniondaleUnited StatesActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.