Description:
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.
Title
- Brief Title: Researching the Effect of Exercise on Cancer
- Official Title: Phase 1a/b Trial of Exercise as Interception Therapy for Primary High-Risk Cancer
Clinical Trial IDs
- ORG STUDY ID:
20-378
- NCT ID:
NCT04589468
Conditions
- Breast Cancer
- Prostate Cancer
- Colorectal Cancer
- Stage I Breast Cancer
- Stage II Breast Cancer
- Stage III Breast Cancer
- Stage I Prostate Cancer
- Stage II Prostate Cancer
- Stage III Prostate Cancer
- Stage I Colorectal Cancer
- Stage II Colorectal Cancer
- Stage III Colorectal Cancer
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Dose-Finding/Escalation | Experimental | Fifty (n=50) post-treatment patients with colorectal cancer and detectable ctDNA. The study will use an adaptive continuous reassessment method (CRM) design to assign patients sequentially at trial entry to one of five escalated doses depending on the feasibility / tolerability of exercise therapy evaluated over the total treatment period. The primary objective of this phase 1a trial is to identify the RP2D of exercise therapy for further evaluation in the phase 1b trial. | |
Dose Expansion | Experimental | An independent cohort of 20 post-treatment patients with colorectal cancer and detectable ctDNA. This cohort expansion trial will only evaluate the RP2D identified in the phase 1a trial. The primary objective of this phase 1b trial is to further evaluate the feasibility, safety, and biological activity of the RP2D. | |
Eligibility Criteria
Inclusion Criteria:
- Postsurgical diagnosis of stage 2 or 3 colorectal cancer
- No evidence of disease as per standard imaging
- Age ≥ 18
- Detectable ctDNA
- Interval of ≥ 1 month but ≤ 5 years following completion of all definitive adjuvant
therapy
- Non-exercising (i.e., ≤ 30 mins of moderate or vigorous exercise/wk, as assessed by
remote activity and heart rate tracking for a 7-day period prior to study entry)
- Cleared for exercise participation as per screening clearance via PAR-Q+
Exclusion Criteria:
- Enrollment onto any other interventional investigational study
- 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Identify the recommended phase 2 dose (RP2D) of exercise for testing in the phase 1b. |
Time Frame: | 24 weeks |
Safety Issue: | |
Description: | 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. |
Details
Phase: | N/A |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Memorial Sloan Kettering Cancer Center |
Trial Keywords
- Breast Cancer
- Prostate Cancer
- Colorectal Cancer
- exercise
- ctDNA
- 20-378
- Memorial Sloan Kettering Cancer Center
Last Updated
July 30, 2021