Step Down Colon Cancer Risk

Washington University School of Medicine17 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Adenomatous Polyps

Interventions

WalkingBEHAVIORAL

* 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.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

Primary Outcomes

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

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

Time frame: 3 months

Secondary Outcomes

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.

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

Time frame: 3 months

Data from ClinicalTrials.gov

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