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NCT00668161 · ClinicalTrials.gov registry record · Phase 2
Effect of Exercise on Biomarkers of Colon Cancer Risk
A Phase 2 study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 202
- Enrollment target
NCT00668161 is a Phase 2 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 202 participants.
The verdict
NCT00668161, a Phase 2 study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 202 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Exercise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 2001-01 |
| Est. Completion | 2005-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00668161
The ClinicalTrials.gov registry entry for NCT00668161 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 202 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Exercise is the first listed.
NCT00668161 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00668161 about?
NCT00668161 is a clinical study titled "Effect of Exercise on Biomarkers of Colon Cancer Risk". 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...
What is the current status of trial NCT00668161?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 202 participants. The study started on 2001-01. Estimated completion is 2005-02.
What interventions are being tested in trial NCT00668161?
The interventions under investigation include: Exercise (BEHAVIORAL).
Who is sponsoring clinical trial NCT00668161?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
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