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Effect of Exercise on Biomarkers of Colon Cancer Risk (APPEAL)

Primary Purpose

Colon Cancer Prevention

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Exercise

About this trial

This is an interventional prevention trial for Colon Cancer Prevention

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Fred Hutchinson Cancer Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm Description

Exercise

Control

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT00668161

First Posted

April 24, 2008

Last Updated

November 26, 2012

Sponsor

Fred Hutchinson Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT00668161

Brief Title

Effect of Exercise on Biomarkers of Colon Cancer Risk

Acronym

APPEAL

Official Title

Exercise Intervention Trial for Colorectal Polyp Patients

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

January 2001 (undefined)

Primary Completion Date

December 2004 (Actual)

Study Completion Date

February 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Fred Hutchinson Cancer Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 30 observational studies, and appears to be independent of effects of diet, body fat mass, and other potential confounding factors. Prior to large-scale recommendations regarding exercise as a means of preventing colon cancer, however, more information is needed regarding the type of exercise, when it must be initiated, and how much must be done, in order to produce a protective effect. Information on the mechanisms and biological pathways through which exercise might protect the colon will aid in developing the answers to these questions. This is a randomized controlled trial of a one-year moderate/vigorous exercise intervention vs. delayed- exercise control on various biomarkers of colon cancer risk in persons that have undergone a colonoscopy within the past 36 months.. The trial is designed to establish the effects of the exercise intervention on colorectal cell proliferation and terminal differentiation, and on factors that may lie in the pathway between exercise and proliferation and apoptosis, in colon and rectal epithelium. It will provide data on: 1) the efficacy of a one-year moderate intensity aerobic exercise program in modulating these processes to a pattern considered low risk for colon cancer, and 2) the mechanisms whereby exercise may lower colon cancer risk in humans. To the investigators' knowledge, this will be the first study of its kind.

Detailed Description

The specific aims of the proposed study are: 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colon Cancer Prevention

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

202 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Exercise

Arm Title

Arm Type

No Intervention

Arm Description

Control

Intervention Type

Behavioral

Intervention Name(s)

Exercise

Intervention Description

60 minutes/session of aerobic exercise, 6 d/week at 50-50% HHR. All sessions will begin with 10 minutes of stretching and 5 minutes of warm-up, and will end with 5 minutes of cool down.

Primary Outcome Measure Information:

Title

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

Time Frame

Baseline and 12-months

Secondary Outcome Measure Information:

Title

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

Time Frame

Baseline and 12-months

Title

rectal mucosal prostaglandin levels

Time Frame

baseline and 12-months

Title

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

Time Frame

baseline and 12-months

Title

Time Frame

baseline and 12-months

Title

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

Time Frame

baseline and 12-months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Facility Information:

Facility Name

Fred Hutchinson Cancer Research Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98102

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

18202581

Citation

Hawkins VN, Foster-Schubert K, Chubak J, Sorensen B, Ulrich CM, Stancyzk FZ, Plymate S, Stanford J, White E, Potter JD, McTiernan A. Effect of exercise on serum sex hormones in men: a 12-month randomized clinical trial. Med Sci Sports Exerc. 2008 Feb;40(2):223-33. doi: 10.1249/mss.0b013e31815bbba9.

Results Reference

result

PubMed Identifier

18006923

Citation

Abrahamson PE, King IB, Ulrich CM, Rudolph RE, Irwin ML, Yasui Y, Surawicz C, Lampe JW, Lampe PD, Morgan A, Sorensen BE, Ayub K, Potter JD, McTiernan A. No effect of exercise on colon mucosal prostaglandin concentrations: a 12-month randomized controlled trial. Cancer Epidemiol Biomarkers Prev. 2007 Nov;16(11):2351-6. doi: 10.1158/1055-9965.EPI-07-0120.

Results Reference

result

PubMed Identifier

17855695

Citation

Campbell KL, McTiernan A, Li SS, Sorensen BE, Yasui Y, Lampe JW, King IB, Ulrich CM, Rudolph RE, Irwin ML, Surawicz C, Ayub K, Potter JD, Lampe PD. Effect of a 12-month exercise intervention on the apoptotic regulating proteins Bax and Bcl-2 in colon crypts: a randomized controlled trial. Cancer Epidemiol Biomarkers Prev. 2007 Sep;16(9):1767-74. doi: 10.1158/1055-9965.EPI-07-0291.

Results Reference

result

PubMed Identifier

17557987

Citation

McTiernan A, Sorensen B, Irwin ML, Morgan A, Yasui Y, Rudolph RE, Surawicz C, Lampe JW, Lampe PD, Ayub K, Potter JD. Exercise effect on weight and body fat in men and women. Obesity (Silver Spring). 2007 Jun;15(6):1496-512. doi: 10.1038/oby.2007.178.

Results Reference

result

PubMed Identifier

16985018

Citation

McTiernan A, Yasui Y, Sorensen B, Irwin ML, Morgan A, Rudolph RE, Surawicz C, Lampe JW, Ayub K, Potter JD, Lampe PD. Effect of a 12-month exercise intervention on patterns of cellular proliferation in colonic crypts: a randomized controlled trial. Cancer Epidemiol Biomarkers Prev. 2006 Sep;15(9):1588-97. doi: 10.1158/1055-9965.EPI-06-0223.

Results Reference

result

PubMed Identifier

34550860

Citation

Duggan C, Yu M, Willbanks AR, Tapsoba JD, Wang CY, Grady WM, McTiernan A. Exercise effects on DNA methylation in EVL, CDKN2A (p14, ARF), and ESR1 in colon tissue from healthy men and women. Epigenetics. 2022 Oct;17(10):1070-1079. doi: 10.1080/15592294.2021.1982512. Epub 2021 Oct 6.

Results Reference

derived

PubMed Identifier

23036856

Citation

Imayama I, Alfano CM, Mason CE, Wang C, Xiao L, Duggan C, Campbell KL, Foster-Schubert KE, Wang CY, McTiernan A. Exercise adherence, cardiopulmonary fitness and anthropometric changes improve exercise self-efficacy and health-related quality of life. J Phys Act Health. 2013 Jul;10(5):676-89. doi: 10.1123/jpah.10.5.676. Epub 2012 Oct 4.

Results Reference

derived

PubMed Identifier

22368219

Citation

Campbell K, Foster-Schubert K, Xiao L, Alfano C, Bertram LC, Duggan C, Irwin M, McTiernan A. Injuries in sedentary individuals enrolled in a 12-month, randomized, controlled, exercise trial. J Phys Act Health. 2012 Feb;9(2):198-207. doi: 10.1123/jpah.9.2.198.

Results Reference

derived

PubMed Identifier

21371498

Citation

Imayama I, Alfano CM, Cadmus Bertram LA, Wang C, Xiao L, Duggan C, Campbell KL, Foster-Schubert KE, McTiernan A. Effects of 12-month exercise on health-related quality of life: a randomized controlled trial. Prev Med. 2011 May;52(5):344-51. doi: 10.1016/j.ypmed.2011.02.016. Epub 2011 Mar 1.

Results Reference

derived

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Effect of Exercise on Biomarkers of Colon Cancer Risk

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