Folate-Depleted Diet Compared With Folate-Supplemented Diet in Preventing Colorectal Cancer in Patients at High Risk for Colorectal Cancer - Article
Clinical Trial: Folate-Depleted Diet Compared With Folate-Supplemented Diet in Preventing Colorectal Cancer in Patients at High Risk for Colorectal Cancer
This study is currently recruiting patients.
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||Treatment or Intervention||Phase|
|Colon Cancer |
| Drug: folic acid |
Procedure: biologically based therapies
Procedure: cancer prevention intervention
Procedure: chemoprevention of cancer
Procedure: complementary and alternative therapy
Procedure: dietary intervention
Procedure: dietary modification
Procedure: nutritional supplementation
|Phase I |
MedlinePlus related topics: Colorectal Cancer
Study Type: Interventional
Study Design: Prevention
- 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.
- 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.
- 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.
Ages Eligible for Study: 40 Years - 72 Years, Genders Eligible for Study: Both
Accepts Healthy Volunteers
- 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
- At least 6 months
- No excessive bleeding or coagulation disorder
- ALT or AST ≤ 2 times upper limit of normal
- No unexplained elevated alkaline phosphatase
- Creatinine ≤ 2.0 mg/dL
- Homocysteine concentration ≤ 17um/L
- No sustained blood pressure > 150/95 mm Hg for 3 consecutive readings
- 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
- 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
- No prior gastrointestinal surgery, including gastrectomy or small or large bowel resections
- Prior appendectomy or surgery of the esophagus allowed
- 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
- Simivastatin 5 or 10 mg/day
Location and Contact Information
Cancer Center at Tufts - New England Medical Center, Boston, Massachusetts, 02111-1854, United States; Recruiting
Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York, 10461, United States; Recruiting
Rockefeller University Hospital, New York, New York, 10021-6399, United States; Recruiting
Roswell Park Cancer Institute, Buffalo, New York, 14263-001, United States; Recruiting
Strang Cancer Prevention Center, New York, New York, 10021-6399, United States; Recruiting
Jim Marshall, PhD, Principal Investigator, Roswell Park Cancer Institute
Record last reviewed: December 2004
Last Updated: April 4, 2005
Record first received: November 9, 2004
ClinicalTrials.gov Identifier: NCT00096330
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005
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