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Sponsors and Collaborators: |
Rockefeller University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00096330 |
RATIONALE: Chemoprevention therapy is the use of certain agents to try to prevent the development of cancer. The use of folic acid may be effective in preventing colorectal cancer. Eating a diet rich in folic acid may prevent the development of colorectal cancer.
PURPOSE: This randomized phase I trial is studying how well a folate-depleted diet works compared to a folate-supplemented diet in preventing colorectal cancer in patients who are at high risk for developing colorectal cancer.
Condition | Intervention | Phase |
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Colorectal Cancer |
Dietary Supplement: dietary intervention Dietary Supplement: folic acid |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Single Blind |
Official Title: | Phase I Clinical Study of Folate |
Estimated Enrollment: | 20 |
Study Start Date: | September 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, single-blind study.
Randomization: After completion of the run-in period, patients are randomized to 1 of 2 arms.
PROJECTED ACCRUAL: A total of 20 patients (10 per arm) will be accrued for this study within 2.5 years.
Ages Eligible for Study: | 40 Years to 72 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
DISEASE CHARACTERISTICS:
Healthy persons at increased risk for colorectal neoplasia due to 1 of the following reasons:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
No prior gastrointestinal surgery, including gastrectomy or small or large bowel resections
Other
No concurrent lipid-lowering medications
The following concurrent statin drugs are allowed provided patient has been taking a stable dose for ≥ 1 month:
United States, Massachusetts | |
Tufts-NEMC Cancer Center | |
Boston, Massachusetts, United States, 02111-1854 | |
United States, New York | |
Albert Einstein Cancer Center at Albert Einstein College of Medicine | |
Bronx, New York, United States, 10461 | |
Rockefeller University Hospital | |
New York, New York, United States, 10021-6399 | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263-0001 | |
Strang Cancer Prevention Center | |
New York, New York, United States, 10021 |
Principal Investigator: | Jim Marshall, PhD | Roswell Park Cancer Institute |
Study ID Numbers: | CDR0000393455, AECM-0401022E, NEMCH-6060, RPCI-EPR-20703, RUH-PHO-0514-0404 |
Study First Received: | November 9, 2004 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00096330 History of Changes |
Health Authority: | United States: Federal Government |
colon cancer rectal cancer |
Vitamin B Complex Digestive System Neoplasms Hematinics Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Rectal Neoplasm Trace Elements Intestinal Diseases |
Rectal Diseases Intestinal Neoplasms Folic Acid Digestive System Diseases Rectal Cancer Vitamins Gastrointestinal Neoplasms Micronutrients Colorectal Neoplasms |
Digestive System Neoplasms Vitamin B Complex Hematinics Gastrointestinal Diseases Growth Substances Hematologic Agents Physiological Effects of Drugs Colonic Diseases Intestinal Diseases Rectal Diseases Pharmacologic Actions |
Intestinal Neoplasms Folic Acid Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Vitamins Gastrointestinal Neoplasms Micronutrients Colorectal Neoplasms |