NCT04589468

Researching the Effect of Exercise on Cancer

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
OTHER	Exercise	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.

Timeline

• Start date: 2020-10-02
• Primary completion: 2026-10-02
• Completion: 2026-10-02
• First posted: 2020-10-19
• Last updated: 2026-02-06

Locations

8 sites across 1 country: United States