NCT01476631

Step Down Colon Cancer Risk

Step Down Colon Cancer Risk: A Pilot Intervention for Colon Cancer Risk Reduction

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Adenomatous Polyps

Interventions

Type	Name	Description
BEHAVIORAL	Walking	* 7 days prior to baseline participants must wear a blinded pedometer * At baseline information on the blinded pedometer will downloaded to the computer for analysis as well as number of days worn and hours of wear. Sociodemographic, cancer risk factors, height/weight, fast blood draw to check levels on insulin, C-peptide, IL-6 and PEG-2 and questionnaires PPAQ, Exercise Confident Survey and Sallis Social Support Scale, Day/night; Home/Work, neighborhood safety, HINTS, IPAPS, CES-D, Brief COPE, Urban and Life Stress Scale.

Timeline

• Start date: 2008-11-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2011-11-22
• Last updated: 2013-08-05

Locations

1 site across 1 country: United States