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.
Stage 3 or
ctDNA positive
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,
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
Sequential
Exercise
Other interventionExercise therapy in both phases will consist of individualized walking delivered 3 to 6 times weekly (over a 7-day period). Exercise treatment will be delivered for up to 18 months, or until progression of disease or withdrawal of consent, whichever comes first. The phase 1a trial will assess five doses of exercise therapy (i.e., 90, 150, 225, 300, and 375 mins/wk) delivered following a non-linear (i.e., exercise dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule. The phase 1b trial will only test one dose of exercise therapy - the RP2D identified in the phase 1a trial.
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.
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
