Exploring how exercise affects cancer recurrence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the impact of aerobic exercise on cancer recurrence by measuring levels of circulating tumor DNA (ctDNA) in patients previously treated for breast, prostate, or colorectal cancer. Researchers aim to determine the optimal level of exercise that is safe and effective in reducing ctDNA levels, which may indicate a lower risk of cancer returning. Participants will engage in varying intensities of exercise over a specified duration to identify the most beneficial regimen. The findings could lead to new recommendations for post-treatment care in cancer survivors.

Why it matters

Who can join: the full rules

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

Where it's running

• City of Hope Medical Center
  Durate, California, United States Recruiting
• Natera, Inc. (Data or Specimen Analysis Only)
  San Carlos, California, United States Not yet recruiting
• Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
  Basking Ridge, New Jersey, United States Active not recruiting
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
  Middletown, New Jersey, United States Active not recruiting
• Memorial Sloan Kettering Bergen (Limited Protocol Activities)
  Montvale, New Jersey, United States Active not recruiting
• Memorial Sloan Kettering Commack (Limited Protocol Activities)
  Commack, New York, United States Active not recruiting

Study contacts

• Principal investigator: Lee Jones, MD — City of Hope Medical Center
• Study coordinator: Lee Jones, MD
• Email: leejones@coh.org
• Phone: 6262184673

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.