Status:
COMPLETED
Folate-Depleted Diet Compared With Folate-Supplemented Diet in Preventing Colorectal Cancer in Patients at High Risk for Colorectal Cancer
Lead Sponsor:
Roswell Park Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Eligibility:
All Genders
40-72 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
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) i...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00096330
Start Date
September 1 2004
End Date
March 1 2008
Last Update
January 13 2014
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001