Step Down Colon Cancer Risk

NCT ID: NCT01476631

Last Updated: 2013-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-04-30

Brief Summary

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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

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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

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Adenomatous Polyps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm A: 30 minutes walking

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

Group Type EXPERIMENTAL

Walking

Intervention Type BEHAVIORAL

* 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.

Arm B: 60 minutes walking

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

Group Type EXPERIMENTAL

Walking

Intervention Type BEHAVIORAL

* 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathleen Y. Wolin, ScD, FACSM

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 22808053 (View on PubMed)

Related Links

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http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

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201105308

Identifier Type: -

Identifier Source: org_study_id