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RecruitingNot applicable

Researching the Effect of Exercise on Cancer

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether aerobic exercise, which works the heart and lungs, can lower ctDNA—small pieces of cancer DNA in the blood. It aims to find a safe, practical amount of exercise that may help keep cancer from coming back. It is for adults treated for cancer who have a high risk of it coming back and do little exercise.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Had surgery for a solid tumor with a high risk of coming back. For cancers other than breast cancer, this means stage 3 cancer or cancer DNA found in the blood. The first study phase includes only colorectal cancer.
  • For breast cancer, meet the study’s high-risk rules. These involve cancer left in the breast or nearby lymph nodes after chemotherapy before surgery, hormone and HER2 test results, and cancer risk scores.
  • Have no signs of cancer now.
  • Finished all main treatment given after surgery at least 1 month but no more than 2 years ago.
  • Usually do less than 30 minutes of moderate exercise and less than 20 minutes of hard exercise each week. Activity and heart rate will be tracked for 7 days. The study leader may allow slightly higher amounts.
  • Be cleared to exercise through the study’s health screening.
  • Be willing to follow all study steps.

Who can't join

  • Are in another study testing a treatment or other action, unless the study leader decides it will not affect this study’s results.
  • Have another current invasive cancer—cancer that has grown into nearby tissue.
  • Have any cancer that has spread to distant parts of the body.
  • Have another health problem or illness that the study doctor thinks makes this study a poor fit.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (9)

CA

NJ

NY