Clinical Trial: Step Down Colon Cancer Risk
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Step Down Colon Cancer Risk: A Pilot Intervention for Colon Cancer Risk Reduction
Brief Summary:
Hypothesis 1: Exercise will decrease serum markers in a dose response manner.
Hypothesis 2: Participants in the 60 minute intervention will have significantly higher physical activity levels than those in the 30 minute intervention at three months.
Detailed Summary:
Primary Aim: To conduct a dose response pilot trial of low (30 min/day) or high (60 min/day) dose exercise in men and women at increased risk of colon cancer. The major outcomes are changes in serum levels of four risk-related biomarkers: insulin, C-peptide, IL-6 and PGE-2.
Secondary Aim. To compare changes in the secondary outcome of physical activity over three months.
Sponsor: Washington University School of Medicine
Current Primary Outcome: Exercise will decrease serum markers (insulin, C-peptide, IL-6 and PGE-2) in a dose response manner. [ Time Frame: 3 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Participants in the 60 minute intervention will have significantly higher physical activity levels (measured by pedometer and accelerometer) than those in the 30 minute intervention at three months. [ Time Frame: 3 months ]
Original Secondary Outcome: Same as current
Information By: Washington University School of Medicine
Dates:
Date Received: November 9, 2011
Date Started: November 2008
Date Completion:
Last Updated: August 2, 2013
Last Verified: August 2013