Phase 1a/b Trial of Exercise as Interception Therapy for Primary High-Risk Cancer
| Registry | NCT04589468 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; non randomized, sequential, masking: none, prevention |
| Enrollment | 51 (Estimated) |
| Sponsor | City of Hope Medical Center (Other); collaborators: National Cancer Institute (NCI) |
| Conditions | 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 |
| Interventions | Exercise (Other) |
| Dates | start 2026-10-30 (estimated), primary completion 2028-02-13 (estimated), completion 2028-02-13 (estimated), first posted 2020-10-19, last updated 2026-08-27 |
| Locations | 9 sites in United States |
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All trials for Breast Cancer All trials for Prostate Cancer All trials of 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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Dose-Finding/Escalation | Experimental | Other: Exercise | 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. |
| Dose Expansion | Experimental | Other: Exercise | 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. |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| 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 |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Harrison, New York | United States | Active not recruiting |
| Memorial Sloan Kettering Cancer Center | New York, New York | United States | Active not recruiting |
| Memorial Sloan Kettering Nassau (Limited Protocol Activities) | Uniondale, New York | United States | Active not recruiting |
NIH grants: P30CA033572