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Step Down Colon Cancer Risk: A Pilot Intervention for Colon Cancer Risk Reduction


N/A
50 Years
80 Years
Not Enrolling
Both
Adenomatous Polyps

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Trial Information

Step Down Colon Cancer Risk: A Pilot Intervention for Colon Cancer Risk Reduction


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Exercise will decrease serum markers (insulin, C-peptide, IL-6 and PGE-2) in a dose response manner.

Outcome 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.

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Kathleen Y. Wolin, ScD, FACSM

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

201105308

NCT ID:

NCT01476631

Start Date:

June 2009

Completion Date:

January 2010

Related Keywords:

  • Adenomatous Polyps
  • Colonic Neoplasms
  • Adenomatous Polyps

Name

Location
Washington University School of Medicine Saint Louis, Missouri  63110