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Exercise Intervention Trial for Colorectal Polyp Patients


Phase 2/Phase 3
40 Years
75 Years
Not Enrolling
Both
Colon Cancer Prevention

Thank you

Trial Information

Exercise Intervention Trial for Colorectal Polyp Patients


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 undergone a
colonoscopy within the past 36 months on proliferation rate in the upper part of colon
and rectal mucosa crypts.

2. To also measure the effects of a one-year moderate/vigorous intensity aerobic exercise
program vs. delayed-exercise control program in persons that have undergone a
colonoscopy within the past 36 months on:

- expression of apoptosis-related proteins (bax/bcl-2 ratio) in colon and rectal
mucosal biopsies

- rectal mucosal prostaglandin levels

- fasting serum/plasma insulin, glucose, triglycerides, insulin-like growth factor
1(IGF-1), and IGF binding protein-3 (IGFPB-3)

- body fat mass and distribution (body mass index, waist and hip circumferences,
bioelectrical impedance, DEXA scan)

- subcutaneous abdominal and intra-abdominal fat mass (measured by one-slice CT scan
at the L4 level)

- fitness (VO2max)

- quality of life (measured by standardized self-report instruments)

- sleep quality


Inclusion Criteria:



- 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 Criteria:

- 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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Outcome Measure:

Proliferation rate in the upper part of colon and rectal mucosa crypts.

Outcome Time Frame:

Baseline and 12-months

Safety Issue:

No

Authority:

United States: Federal Government

Study ID:

APPEAL CA77572-01

NCT ID:

NCT00668161

Start Date:

January 2001

Completion Date:

February 2005

Related Keywords:

  • Colon Cancer Prevention
  • Colonic Neoplasms

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109