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Colon Cancer PreventionPhase 2/3APPEALNCT00668161

Effect of Exercise on Biomarkers of Colon Cancer Risk

A Phase 2/3 study testing Exercise in people with Colon Cancer Prevention, run by Fred Hutchinson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Colon Cancer Prevention
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
202 participants
Where
1 siteUnited States
Study dates
Jan 2001to Feb 2005
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98102

Other trials in United States

About this study

Official title: Exercise Intervention Trial for Colorectal Polyp Patients

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.

Read the 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 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
Being tested
Exercise

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseBehavioural

    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.

Study groups in NCT00668161
Study groupRoleWhat they receive
1ExperimentalExercise
Receives: Behavioral: Exercise
2No interventionControl

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline and 12-months

Secondary outcomes (5)

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

    Measured: Baseline and 12-months

  2. rectal mucosal prostaglandin levels

    Measured: baseline and 12-months

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

    Measured: baseline and 12-months

  4. 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)

    Measured: baseline and 12-months

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

    Measured: baseline and 12-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2008 (estimated)
  2. Study startJan 2001
  3. Primary completionDec 2004
  4. Study completionFeb 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Investigator
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00668161
Sponsor's protocol ID
APPEAL CA77572-01
Other IDs
FHCRC-4838, R01 CA77572-01
Acronym
APPEAL
Status last verified
Nov 2012
First submitted
24 Apr 2008
Last updated
28 Nov 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 18202581

  • 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.

    PubMed 18006923

  • 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.

    PubMed 17855695

  • 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.

    PubMed 17557987

  • 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.

    PubMed 16985018

  • 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.

    PubMed 34550860

  • 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.

    PubMed 23036856

  • 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.

    PubMed 22368219

  • 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.

    PubMed 21371498

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Exercise in people with Colon Cancer Prevention, run by Fred Hutchinson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proliferation rate in the upper part of colon and rectal mucosa crypts. (time frame: Baseline and 12-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00668161, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2012.

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