Step Down Colon Cancer Risk

Adenomatous Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01476631
• Other study ID #: 201105308
• Status: Terminated
• Phase: N/A
• First received: November 9, 2011
• Last updated: August 2, 2013
• Start date: November 2008
• Est. completion date: April 2010

Study information

• Verified date: August 2013
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adenomatous Polyps

Intervention

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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise will decrease serum markers (insulin, C-peptide, IL-6 and PGE-2) in a dose response manner.	Changes in serum levels of four risk-related biomarkers: insulin, C-peptide, IL-6 and PGE-2 comparing baseline and 3 months serum levels.	3 months	No
Secondary	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.	Comparing changes in the secondary outcome of physical activity over three months, as measured by pedometer and accelerometer.	3 months	No

External Links

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