Step Down Colon Cancer Risk

Not Applicable

Terminated

• Conditions: Adenomatous Polyps

• Registration Number: NCT01476631
• Lead Sponsor: Washington University School of Medicine

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 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.

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Study First Submitted: 2011-11-09
• Study First Submitted QC: 2011-11-17
• Study First Posted: 2011-11-22
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-02
• Last Update Posted: 2013-08-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• aged 50 to 80
• no personal cancer history
• found to have an adenomatous polyp upon colonoscopy at BJH/WUSM in the previous six months
• no contraindications to beginning an exercise program
• no previous diagnosis of familial polyposis syndromes
• no previous diagnosis of ulcerative colitis or Crohn's disease;

Exclusion Criteria

• Participants who are regular NSAID users will be excluded as this may interfere with the measurement of inflammatory marker outcomes. Regular use is defined as taking 80mg or more per day of aspirin, ibuprofen, naproxen or other NSAID 5 or more days of the week.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Exercise will decrease serum markers (insulin, C-peptide, IL-6 and PGE-2) in a dose response manner.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States