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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
  Purpose

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.


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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Step Down Colon Cancer Risk: A Pilot Intervention for Colon Cancer Risk Reduction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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.


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. [ 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.


Enrollment: 16
Study Start Date: June 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: Randomized to 30 min walking or 60 min walking x 3 mon 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.

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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01476631

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Kathleen Y. Wolin, ScD, FACSM Washington University School of Medicine
  More Information

Additional Information:
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine  This link exits the ClinicalTrials.gov site

No publications provided by Washington University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01476631     History of Changes
Other Study ID Numbers: 201105308
Study First Received: November 9, 2011
Last Updated: November 17, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Colonic Neoplasms
Adenomatous Polyps
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 16, 2013