NCT00096330已完成1 期
Phase I Clinical Study of Folate
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- •Analyze the effects of a folate-depleted vs a folate-supplemented diet on folate-related DNA endpoints
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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:
- •Performance status
- •Ambulatory
- •Life expectancy
- •At least 6 months
- •Hematopoietic
- •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
- •Cardiovascular
- •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
- •Chemotherapy
- •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
- •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
- 另有 6 项未显示
排除标准
- 未提供
结局指标
主要结局
•Analyze the effects of a folate-depleted vs a folate-supplemented diet on folate-related DNA endpoints
时间窗: pre and post treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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