Status:
COMPLETED
Effect of Folate on DNA in Colon Tissue and Blood Samples From Patients at Increased Risk of Developing Colorectal Neoplasia
Lead Sponsor:
Rockefeller University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Eligibility:
All Genders
40-72 years
Phase:
PHASE1
Brief Summary
RATIONALE: Studying samples of blood and tissue from patients at risk of cancer in the laboratory may help doctors learn more about the effect of folate on DNA and identify biomarkers related to cance...
Detailed Description
OBJECTIVES: * To analyze the effects of changes in levels of dietary folate intake on damage to DNA and repair capacity, mRNA expression, and DNA uracil incorporation in peripheral blood mononuclear ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- At increased risk for developing colorectal neoplasia due to 1 of the following:
- Personal history of colorectal adenomatous polyps
- Family history of colorectal adenoma or adenocarcinoma
- No hereditary nonpolyposis colorectal cancer (HNPCC)
- No more than one first-degree family member with colorectal or endometrial malignancies
- PATIENT CHARACTERISTICS:
- Ambulatory
- Female patients must be ≥ 2 years post-menopausal (i.e., 2 years after the last menstrual period)
- Negative pregnancy test
- Male patients must use effective contraception during and for 2 months after completion of study treatment (for male patients enrolled in the folate depletion group)
- Serum folate level ≤ 20 ng/mL
- Plasma vitamin B12 level ≥ 250 pg/mL
- Serum homocysteine level ≤ 17 μmol/L
- ALT or AST ≤ 2 times upper limit of normal
- No unexplained elevated alkaline phosphatase
- Creatinine ≤ 2.0 mg/dL
- HIV negative
- No folate metabolism abnormalities or predisposing conditions
- No prior malignancy except nonmelanoma skin cancer
- No intestinal malabsorption or inflammatory bowel disease
- No excessive bleeding or coagulation disorder
- No untreated hyperthyroidism
- No diabetes mellitus requiring insulin
- No daily alcohol intake \> 2 ½ shot glasses of whisky or three 8-ounce glasses of beer or wine
- No sustained blood pressure \> 150/95 mm Hg for three consecutive readings
- No other serious illness that would limit life expectancy to \< 6 months
- PRIOR CONCURRENT THERAPY:
- 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 of aspirin (≥ 2 tablets of 325 mg regular strength OR \> 1 tablet of 500 mg extra strength aspirin) per day
- The following drugs are allowed for cardiovascular prophylaxis provided the patient has been taking the drug regularly for ≥ 1 month and continues to take the same dose during study participation:
- One or two regular strength aspirin tablets (i.e., 325 mg per tablet) per day
- One baby aspirin tablet (81 mg tablet) per day
- More than 3 months since regular daily ingestion of other non-steroidal anti-inflammatory drugs (NSAIDs)
- No concurrent anticoagulation therapy
- No concurrent sterol-binding resins, such as cholestyramine (for the treatment of high blood cholesterol)
- No other concurrent investigational drugs
- No other concurrent medications that might, in the view of the study physicians, alter rectal mucosal proliferation, folate metabolism, or renal/hepatic metabolism
- No concurrent weight control medications
- No concurrent supplemental folate preparation containing \> 400 mcg of folic acid per day
- No concurrent hormone replacement therapy, including oral, transplanted, or injected contraceptives
- Concurrent thyroid hormone replacement allowed provided the patient is euthyroid
- No concurrent medication interfering with folic acid metabolic effects, including any of the following:
- Methotrexate
- Phenytoin
- Phenobarbital
- Primidone
- Sulfonamides
- Folinic acid derivatives
- No concurrent lipid-lowering medications other than usual doses of the class of drugs known as statins
- The following statin drugs are allowed provided the patient has been taking the drug regularly for ≥ 1 month and continues to take the same dose during study participation:
- Atorvastatin (10 or 20 mg/day)
- Fluvastatin (20 mg 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 :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00611000
Start Date
June 1 2003
Last Update
February 17 2009
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