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Clinical Trial NCT04589468 for Breast Cancer, Prostate Cancer, Colorectal Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer, Stage I Prostate Cancer, Stage II Prostate Cancer, Stage III Prostate Cancer, Stage I Colorectal Cancer, Stage II Colorectal Cancer, Stage III Colorectal Cancer is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Researching the Effect of Exercise on Cancer

Active, not recruiting
Clinical Trial NCT04589468 is an interventional study for Breast Cancer, Prostate Cancer, Colorectal Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer, Stage I Prostate Cancer, Stage II Prostate Cancer, Stage III Prostate Cancer, Stage I Colorectal Cancer, Stage II Colorectal Cancer, Stage III Colorectal Cancer that is active, not recruiting. It started on 2 October 2020 with plans to enroll 33 participants. Led by Memorial Sloan Kettering Cancer Center, it is expected to complete by 2 October 2026. The latest data from ClinicalTrials.gov was last updated on 5 November 2025.
Brief Summary
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.
Official Title

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

Conditions
Breast CancerProstate CancerColorectal CancerStage I Breast CancerStage II Breast CancerStage III Breast CancerStage I Prostate CancerStage II Prostate CancerStage III Prostate CancerStage I Colorectal CancerStage II Colorectal CancerStage III Colorectal Cancer
Other Study IDs
  • 20-378
NCT ID Number
NCT04589468
Start Date (Actual)
2020-10-02
Last Update Posted
2025-11-05
Completion Date (Estimated)
2026-10-02
Enrollment (Estimated)
33
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Keywords
Breast Cancer
Prostate Cancer
Colorectal Cancer
exercise
ctDNA
20-378
Memorial Sloan Kettering Cancer Center
Primary Purpose
Prevention
Design Allocation
Non-Randomized
Interventional Model
Sequential
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalDose-Finding/Escalation
Fifty (n=50) post-treatment patients with colorectal cancer or breast cancer, deemed high-risk of relapse. The study will use an adaptive continuous reassessment method (CRM) design to assign patients sequentially at trial entry to one of five escalated doses depending on the feasibility / tolerability of exercise therapy evaluated over the total treatment period. The primary objective of this phase 1a trial is to identify the RP2D of exercise therapy for further evaluation in the phase 1b trial.
Exercise
Exercise therapy in both phases will consist of individualized walking delivered 3 to 6 times weekly (over a 7-day period). Exercise treatment will be delivered for up to 18 months, or until progression of disease or withdrawal of consent, whichever comes first. The phase 1a trial will assess five doses of exercise therapy (i.e., 90, 150, 225, 300, and 375 mins/wk) delivered following a non-linear (i.e., exercise dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule. The phase 1b trial will only test one dose of exercise therapy - the RP2D identified in the phase 1a trial.
ExperimentalDose Expansion
An independent cohort of 30 post-treatment patients with colorectal (n=15) or breast (n=15) cancer deemed high-risk of relapse. This cohort expansion trial will only evaluate the RP2D identified in the phase 1a trial. The primary objective of this phase 1b trial is to further evaluate the feasibility, safety, and biological activity of the RP2D.
Exercise
Exercise therapy in both phases will consist of individualized walking delivered 3 to 6 times weekly (over a 7-day period). Exercise treatment will be delivered for up to 18 months, or until progression of disease or withdrawal of consent, whichever comes first. The phase 1a trial will assess five doses of exercise therapy (i.e., 90, 150, 225, 300, and 375 mins/wk) delivered following a non-linear (i.e., exercise dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule. The phase 1b trial will only test one dose of exercise therapy - the RP2D identified in the phase 1a trial.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Identify the recommended phase 2 dose (RP2D) of exercise for testing in the phase 1b.
Using an adaptive phase 1 (non-randomized) design, non-exercising (i.e., \<60 mins/wk of moderate or vigorous exercise) post-treatment patients with primary breast, prostate, or colorectal cancer and detectable ctDNA (n=50) will be administered one of five escalating dose levels.
24 weeks
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  • 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

  • Enrollment onto any other interventional investigational study except interventions determined by the PI not to confound study outcomes
  • 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
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8 Study Locations in 1 Countries

California

Natera, Inc. (Data or Specimen Analysis Only), San Carlos, California, 94070, United States

New Jersey

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, 07645, United States

New York

Memorial Sloan Kettering Commack (Limited Protocol Activities), Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale, New York, 11553, United States