Exploring how exercise affects cancer recurrence
Phase 1a/b Trial of Exercise as Interception Therapy for Primary High-Risk Cancer
This study is testing how different levels of aerobic exercise can help reduce the chances of cancer coming back in people who have been treated for breast, prostate, or colorectal cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 8 sites (San Carlos, California and 7 other locations) |
| Trial ID | NCT04589468 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been treated for high-risk breast, prostate, or colorectal cancer and are currently non-exercising.
Not a fit: Patients with advanced cancer or those who are already engaging in regular exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new non-invasive strategy to reduce cancer recurrence risk through exercise.
How similar studies have performed: Other studies have shown promising results in the role of exercise in cancer recovery, suggesting this approach has potential.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Carlos, California and 7 other locations
- 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 (Recruiting)
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Commack (Limited Protocol Activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States (Recruiting)
Study contacts
- Principal investigator: Lee Jones, PhD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Lee Jones, PhD
- Email: jonesl3@mskcc.org
- Phone: 646-888-8103
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.