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Brief Title: FOcus on Reducing Dose-limiting Toxicities in Colon Cancer With Resistance Exercise Study
Official Title: FOcus on Reducing Dose-limiting Toxicities in Colon Cancer With Resistance Exercise Study
Study ID: NCT03291951
Brief Summary: FORCE is a randomized home-based resistance training/strength training (RT) intervention study for Stage II and III colon cancer patients undergoing chemotherapy. Participants will be 180 newly diagnosed Stage II and III colon cancer patients from Kaiser Permanente of Northern California (KPNC), the Penn State Cancer Institute (PSCI), and the Dana Farber Cancer Institute (DFCI). The intervention will begin within the first weeks of adjuvant chemotherapy and continue exercise through the completion of post-operative chemotherapy. Specifically, the investigators will examine between group differences for RT versus waitlist control for chemotherapy outcomes including dose delays, dose reductions, early stoppage and Grade 3 and 4 toxicities. The investigators will also study changes in muscle mass (MM) and changes in specific inflammatory markers (e.g. CRP, IL-6 and TNF-RII) as potential markers of change in response to RT. To determine effects of change of MM on chemotherapy-specific drug clearance, the investigators will examine the impact body composition changes on the pharmacokinetics (PK) of 5-FU and oxaliplatin, two of the most commonly used drugs for colon cancer.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Kaiser Permanente Division of Research, Oakland, California, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Penn State Cancer Institute, Hershey, Pennsylvania, United States
Name: Bette J Caan, DrPH
Affiliation: Kaiser Permanente
Role: PRINCIPAL_INVESTIGATOR
Name: Kathryn H Schmitz, PhD, MPH
Affiliation: Penn State Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Jeffrey Meyerhardt, MD, MPH
Affiliation: Dana-Farber Cancer Institute
Role: PRINCIPAL_INVESTIGATOR