Step Down Colon Cancer Risk

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT01476631

First received: November 9, 2011

Last updated: November 17, 2011

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 9, 2011

Last Updated Date

November 17, 2011

Start Date ^ICMJE

June 2009

Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Exercise will decrease serum markers (insulin, C-peptide, IL-6 and PGE-2) in a dose response manner. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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 Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01476631 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Step Down Colon Cancer Risk

Official Title ^ICMJE

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 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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Adenomatous Polyps

Intervention ^ICMJE

Behavioral: 30 minutes of walking (=10,000 steps per day) for 3 months

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. Those randomized to Arm A will walk for 30 minutes + 10,000 steps per day for 3 months
Study completion will be the same as baseline evaluations.

Study Arm (s)

Experimental: Arm A: Randomized to 30 min walking or 60 min walking x 3 mon

Intervention: Behavioral: 30 minutes of walking (=10,000 steps per day) for 3 months

Publications *

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. Epub 2012 Jul 13.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2010

Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

50 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01476631

Other Study ID Numbers ^ICMJE

201105308

Has Data Monitoring Committee

Responsible Party

Washington University School of Medicine

Study Sponsor ^ICMJE

Washington University School of Medicine

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Kathleen Y. Wolin, ScD, FACSM

Washington University School of Medicine

Information Provided By

Washington University School of Medicine

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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