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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
51
Exercise 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.
City of Hope Medical Center
Durate, California, United States
RECRUITINGNatera, Inc. (Data or Specimen Analysis Only)
San Carlos, California, United States
NOT_YET_RECRUITINGMemorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
ACTIVE_NOT_RECRUITINGMemorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States
ACTIVE_NOT_RECRUITINGMemorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
ACTIVE_NOT_RECRUITINGMemorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, United States
ACTIVE_NOT_RECRUITINGMemorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States
ACTIVE_NOT_RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
ACTIVE_NOT_RECRUITINGMemorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States
ACTIVE_NOT_RECRUITINGIdentify 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.
Time frame: 24 weeks
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