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 ]

Changes in serum levels of four risk-related biomarkers: insulin, C-peptide, IL-6 and PGE-2 comparing baseline and 3 months serum levels.


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 ]

Comparing changes in the secondary outcome of physical activity over three months, as measured by pedometer and accelerometer.


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