Phase 1a/b Trial of Exercise as Interception Therapy for Primary High-Risk Cancer
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.
• 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