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Active, Not Recruiting

NCT Number: NCT04589468

Researching the Effect of Exercise on Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Exercise

Other

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 outcomes

  1. Identify the recommended phase 2 dose (RP2D) of exercise for testing in the phase 1b.

    Time frame: 24 weeks

    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.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Oct 19, 2020
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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