Step Down Colon Cancer Risk

This study has been terminated.
(not enough patients consented during the funding period)
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01476631
First received: November 9, 2011
Last updated: August 2, 2013
Last verified: August 2013

November 9, 2011
August 2, 2013
November 2008
April 2010   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01476631 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Step Down Colon Cancer Risk
Step Down Colon Cancer Risk: A Pilot Intervention for Colon Cancer Risk Reduction

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Adenomatous Polyps
Behavioral: 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.
  • Experimental: Arm A: 30 minutes walking
    First Step program with 30 minutes of walking and 10,000 steps per day for 3 months.
    Intervention: Behavioral: Walking
  • Experimental: Arm B: 60 minutes walking
    First Step program with 60 minutes of walking and 13,000 steps per day for 3 months.
    Intervention: Behavioral: Walking
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
17
April 2010
April 2010   (final data collection date for primary outcome measure)

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.
Both
50 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01476631
201105308
No
Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Kathleen Y. Wolin, ScD, FACSM Washington University School of Medicine
Washington University School of Medicine
August 2013

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