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Step Down Colon Cancer Risk

Primary Purpose

Adenomatous Polyps

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Walking
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adenomatous Polyps

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A: 30 minutes walking

Arm B: 60 minutes walking

Arm Description

First Step program with 30 minutes of walking and 10,000 steps per day for 3 months.

First Step program with 60 minutes of walking and 13,000 steps per day for 3 months.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 9, 2011
Last Updated
August 2, 2013
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01476631
Brief Title
Step Down Colon Cancer Risk
Official Title
Step Down Colon Cancer Risk: A Pilot Intervention for Colon Cancer Risk Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Terminated
Why Stopped
not enough patients consented during the funding period
Study Start Date
November 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenomatous Polyps

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: 30 minutes walking
Arm Type
Experimental
Arm Description
First Step program with 30 minutes of walking and 10,000 steps per day for 3 months.
Arm Title
Arm B: 60 minutes walking
Arm Type
Experimental
Arm Description
First Step program with 60 minutes of walking and 13,000 steps per day for 3 months.
Intervention Type
Behavioral
Intervention Name(s)
Walking
Intervention Description
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.
Primary Outcome Measure Information:
Title
Exercise will decrease serum markers (insulin, C-peptide, IL-6 and PGE-2) in a dose response manner.
Description
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 Outcome Measure Information:
Title
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.
Description
Comparing changes in the secondary outcome of physical activity over three months, as measured by pedometer and accelerometer.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Y. Wolin, ScD, FACSM
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22808053
Citation
Wolin KY, Fagin C, James AS, Early DS. Promoting physical activity in patients with colon adenomas: a randomized pilot intervention trial. PLoS One. 2012;7(7):e39719. doi: 10.1371/journal.pone.0039719. Epub 2012 Jul 13.
Results Reference
derived
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

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Step Down Colon Cancer Risk

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