Breast Cancer Clinical Trial
Official title:
Phase 1a/b Trial of Exercise as Interception Therapy for Primary High-Risk Cancer
NCT number | NCT04589468 |
Other study ID # | 20-378 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2, 2020 |
Est. completion date | October 2, 2024 |
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.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | October 2, 2024 |
Est. primary completion date | October 2, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Postsurgical diagnosis of high-risk colorectal cancer or high-risk breast cancer as defined by one of the following: ° High-risk colorectal cancer - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | Basking Ridge | New Jersey |
United States | Memorial Sloan Kettering Commack (Limited Protocol Activities) | Commack | New York |
United States | Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Harrison | New York |
United States | Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | Middletown | New Jersey |
United States | Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Montvale | New Jersey |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | Natera, Inc. (Data or Specimen Analysis Only) | San Carlos | California |
United States | Memorial Sloan Kettering Nassau (Limited Protocol Activities) | Uniondale | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identify the recommended phase 2 dose (RP2D) of exercise for testing in the phase 1b. | 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. | 24 weeks |
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