Expired Study
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Buffalo, New York 14263


Purpose:

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.


Study summary:

OBJECTIVES: Primary - Analyze the effects of a folate-depleted vs a folate-supplemented diet on folate-related DNA endpoints (e.g., genomic and gene-specific DNA methylation and DNA strand breaks) in rectal epithelial cells in patients at high risk for colorectal neoplasia. - Analyze the effects of these dietary interventions on folate-related DNA endpoints (e.g., genomic and gene-specific DNA methylation, DNA strand breaks, and uracil incorporation into DNA) in blood mononuclear cells in these patients. Secondary - Analyze the effects of these dietary interventions on the patterns of differential gene expression in rectal epithelial cells and blood mononuclear cells in these patients. OUTLINE: This is a randomized, single-blind study. - Run-in period: Patients are placed on an average folate-containing diet for 56 days. - Randomization: After completion of the run-in period, patients are randomized to 1 of 2 arms. - Arm I (folate depleted diet): Patients are placed on a low-folate diet for 84 days. Patients receive oral folic acid supplementation once daily on days 57-84. - Arm II (folate supplemented diet): Patients continue on an average folate-containing diet for an additional 56 days. Patients receive oral folic acid supplementation once daily on days 1-56. Patients are followed at 4 weeks. PROJECTED ACCRUAL: A total of 20 patients (10 per arm) will be accrued for this study within 2.5 years.


Criteria:

DISEASE CHARACTERISTICS: - Healthy persons at increased risk for colorectal neoplasia due to 1 of the following reasons: - Personal history of colorectal adenomatous polyps - Family history of colorectal adenoma or adenocarcinoma - No history of multiple family members with colorectal neoplasia that is suggestive of dominant hereditary neoplasia PATIENT CHARACTERISTICS: Age - 40 to 72 Performance status - Ambulatory Life expectancy - At least 6 months Hematopoietic - No excessive bleeding or coagulation disorder Hepatic - ALT or AST ≤ 2 times upper limit of normal - No unexplained elevated alkaline phosphatase Renal - Creatinine ≤ 2.0 mg/dL Cardiovascular - Homocysteine concentration ≤ 17um/L - No sustained blood pressure > 150/95 mm Hg for 3 consecutive readings Other - Vitamin B_12 ≥ 250 pg/mL - Folate level ≤ 20 mg/dL - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 4 weeks after study participation - No intestinal malabsorption or inflammatory bowel disease - No prior malignancy except nonmelanoma skin cancer - No calcium metabolism abnormalities or predisposing conditions, such as hyperparathyroidism - No untreated hyperthyroidism - No untreated insulin-requiring diabetes mellitus - No daily alcohol intake > 2 ½ shot glasses of whiskey or three 8 ounce glasses of beer or wine - No other serious illness that might limit life expectancy to < 6 months PRIOR CONCURRENT THERAPY: Biologic therapy - None Chemotherapy - None Endocrine therapy - No concurrent hormone replacement therapy, including oral, transplanted, or injected contraceptives - Concurrent thyroid hormone replacement is allowed as long as the patient is euthyroid for 3 months Radiotherapy - None Surgery - No prior gastrointestinal surgery, including gastrectomy or small or large bowel resections - Prior appendectomy or surgery of the esophagus allowed Other - More than 3 months since regular ingestion of ≥ 650 mg per day of aspirin (≥ 2 tablets of 325 mg regular strength OR > 1 tablet of 500 mg extra strength aspirin) - More than 3 months since regular daily ingestion of nonsteroidal anti-inflammatory drugs - At least 1 month since vitamin, mineral, or herbal supplementation - No other concurrent vitamin, mineral, or herbal supplementation - No concurrent anticoagulants - No concurrent sterol-binding resins (i.e., cholestyramine) - No other concurrent investigational drugs or medications that might alter rectal mucosal proliferation, folate metabolism, or renal/hepatic impairment - No concurrent weight control medications - No concurrent supplemental folate preparations containing > 400 mcg of folic acid per day - No concurrent lipid-lowering medications - The following concurrent statin drugs are allowed provided patient has been taking a stable dose for ≥ 1 month: - Atorvastatin 10 or 20 mg/day - Fluvastatin 20 or 40 mg/day - Lovastatin 10 or 20 mg/day - Pravastatin 10 or 20 mg/day - Simvastatin 5 or 10 mg/day


NCT ID:

NCT00096330


Primary Contact:

Principal Investigator
James Marshall, PhD
Roswell Park Cancer Institute


Backup Contact:

N/A


Location Contact:

Buffalo, New York 14263
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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