Breast Cancer, Colorectal Cancer, Prostate Cancer, Stage I Breast Cancer, Stage I Colorectal Cancer, Stage II Breast Cancer, Stage II Colorectal Cancer, Stage III Breast Cancer, Stage III Colorectal Cancer, Stage III Prostate Cancer, Stage II Prostate Cancer, Stage I Prostate Cancer
Conditions
Keywords
Breast Cancer, Prostate Cancer, Colorectal Cancer, exercise, ctDNA, 20-378, Memorial Sloan Kettering Cancer Center
Brief summary
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.
Interventions
OTHERExercise
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.
Sponsors
City of Hope Medical Center
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identify the recommended phase 2 dose (RP2D) of exercise for testing in the phase 1b. | 24 weeks | 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. |
Countries
United States
Contacts
CONTACTLee Jones, MD
PRINCIPAL_INVESTIGATORLee Jones, MD
City of Hope Medical Center
Outcome results
None listed