Status:
COMPLETED
Effect of Exercise on Biomarkers of Colon Cancer Risk
Lead Sponsor:
Fred Hutchinson Cancer Center
Conditions:
Colon Cancer Prevention
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
PHASE3
Brief Summary
There is strong observational epidemiologic evidence that physical activity is inversely associated with risk of colon cancer occurrence in both men and women. This association has been found in over ...
Detailed Description
The specific aims of the proposed study are: 1. To measure the effects of a one-year moderate/vigorous intensity aerobic exercise program vs. a delayed-exercise control program in persons that have u...
Eligibility Criteria
Inclusion
- Male or female
- Completed a colonoscopy within the past 36 months
- Ages 40-75 years at time of identification
- Sedentary activity pattern
- Gives informed consent, agrees to be randomly assigned
- Able to perform all study requirements, able to follow directions and complete forms
Exclusion
- Colorectal cancer at any time; any other invasive cancer within the past 10 years (simple basal or squamous cell carcinoma okay)
- Plans to leave Western Washington during the follow-up period
- Morbidly obese (BMI \> 41), weight loss of \> 10 pounds in the previous 3 months
- Familial polyposis, Gardner's syndrome, or other known familial colorectal cancer syndrome
- Ulcerative colitis or short bowel
- "Excessive"(\> 3 x week) laxative or enema use that might interfere with rectal crypt studies
- Current use of certain medications likely to interfere with success of the intervention, or with outcomes measures (for example, anticoagulants because of risk from colorectal biopsy, diet medications within past 6 months)
- Diabetes mellitus or fasting glucose \> 140
- Hemochromatosis- if diagnosed by physician
- Abnormal screening labs (hematocrit \< 32 or \> 48, white blood cells \< 3.0 or \> 15.0, potassium \< 3.5 or \> 5.3, fasting glucose \> 140, creatinine \> 2.0), or abnormalities on screening physical exam judged by study physicians to contraindicate participation in an exercise program
- Contraindications for entry into a training program 131 including: unstable angina, uncontrolled hypertension (systolic \> 200, diastolic \> 100), orthostatic hypotension (\>20 mm fall in systolic), moderate/severe aortic stenosis, uncontrolled arrhythmia, uncontrolled congestive heart failure, third degree heart block, pericarditis, myocarditis, pulmonary/systemic embolism within the past 6 months, thrombophlebitis, ST displacement \> 3 mm at rest, history of cardiac arrest)
- Contraindications for exercise testing 131 including: recent (within 6 months) cardiac event (MI, pulmonary edema, myocarditis, pericarditis), unstable angina, uncontrolled arrhythmia, third degree heart block, left bundle branch block, acute congestive failure, recent (within 6 months) pulmonary/systemic embolus, severe electrolyte abnormality
- Meets criteria to stop screening exercise test 131 as decided by overseeing physician
- Volunteering in order to lose weight; alcohol or drug abuse, significant mental or emotional problems such as would interfere with compliance (as assessed by study staff impression)
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2005
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT00668161
Start Date
January 1 2001
End Date
February 1 2005
Last Update
November 28 2012
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98102