The Effect of Two Dose Levels of Eicosapentaenoic Acid (EPA) on Apoptosis and Cell Proliferation in the Colonic Mucosa of Patients With a History of Colonic Polyps.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- To measure levels of apoptosis in the normal colonic mucosa in subjects with a history of colonic adenomas, before and after treatment with EPA 99%.
研究概览
简要总结
The purpose of this study is to determine the effect of two doses purified EPA (an omega-3 fatty acid), on apoptosis (natural cell death) and cell proliferation (formation of new cells) in the lining of the colon for patients with a history of colonic polyps.
详细描述
Colorectal cancer is generally accepted to develop from changes within colonic adenomatous polyps. More than 90% of new large bowel cancers arise sporadically. The molecular events leading to the development of colorectal cancer from polyps are characterised by an imbalance in cell proliferation (formation of new cells) and apoptosis (natural cell death) from changes in the genes involved in normal colon cells.
Recent work at St George's Hospital Medical School, London, has shown significant beneficial effects on cell proliferation and apoptosis rates in the lining of the colon in subjects with a history of colonic adenomas using a highly purified, free-fatty acid form of eicosapentaenoic acid (EPA).
Comparator(s): 2g EPA per day for 6 months and 1g EPA per day for 6 months will be compared against placebo for 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged over 18
- •Patients of child-bearing potential must demonstrate a negative pregnancy test at screening, and should use a reliable form of contraception during the trial and for 1 month afterwards, e.g:
- •Oral contraceptive + condom
- •Intra-uterine device (IUD)+ condom
- •Diaphragm with spermicide + condom
- •Male partners of women of child bearing potential should use a reliable form of contraception during the trial and for 1 month afterwards, e.g:
- •Oral contraceptive + condom
- •Intra-uterine device (IUD)+ condom
- •Diaphragm with spermicide + condom
- •Patients must have a known history of colorectal adenomata and be under clinical follow-up for these, or be found to have one or more of these at the time of colonoscopy
- •Patients must have provided written informed consent to participate
排除标准
- •Patients who are allergic to fish
- •Patients who have diabetes mellitus
- •Patients who are pregnant or breast-feeding
- •Patients taking aspirin or other non-steroidal anti-inflammatory drugs on a regular basis
- •Patients who have aspirin-sensitive asthma
- •Patients suffering from haemorrhagic disorders
- •Patients who are taking warfarin or other anticoagulants
- •Patients who have significant abnormalities on their screening blood tests
- •Patients taking lipid lowering medication
- •Patients with known inflammatory bowel disease (IBD), or previously unknown IBD until discovered at the time of their colonoscopy
- •Patients with gastrointestinal malabsorptive disease
- •Patients belonging to a known polyposis syndrome (e.g. FAP, HNPCC)
- •Patients with a previous colonic resection for colorectal cancer
- •Patients who are taking other fish-oil supplements (e.g. cod liver oil) who are unwilling to stop them for the duration of the study
- •Patients who are deemed mentally incompetent, or have a history of anorexia nervosa or bulimia
- •Patients with a history of alcohol or drug abuse, including laxative abuse
- •Patients considered by their physician unlikely to be able to comply with the protocol.
- •Patients who have taken part in an experimental drug study in the preceding 2 months.
研究组 & 干预措施
1g EPA per day
干预措施: Eicosapentaenoic Acid (EPA) (Drug)
1g EPA per day
干预措施: Endoscopy (Procedure)
1g EPA per day
干预措施: Biopsies taken (Procedure)
1g EPA per day
干预措施: Clinical chemistry (Procedure)
1g EPA per day
干预措施: Haematology (Procedure)
1g EPA per day
干预措施: Physical examination (Procedure)
1g EPA per day
干预措施: Vital signs (Procedure)
1g EPA per day
干预措施: Urine pregnancy test (Procedure)
1g EPA per day
干预措施: Completion of patient diary card (Procedure)
2g EPA per day
干预措施: Eicosapentaenoic Acid (EPA) (Drug)
2g EPA per day
干预措施: Endoscopy (Procedure)
2g EPA per day
干预措施: Biopsies taken (Procedure)
2g EPA per day
干预措施: Clinical chemistry (Procedure)
2g EPA per day
干预措施: Haematology (Procedure)
2g EPA per day
干预措施: Physical examination (Procedure)
2g EPA per day
干预措施: Vital signs (Procedure)
2g EPA per day
干预措施: Urine pregnancy test (Procedure)
2g EPA per day
干预措施: Completion of patient diary card (Procedure)
Placebo
干预措施: Endoscopy (Procedure)
Placebo
干预措施: Biopsies taken (Procedure)
Placebo
干预措施: Clinical chemistry (Procedure)
Placebo
干预措施: Haematology (Procedure)
Placebo
干预措施: Physical examination (Procedure)
Placebo
干预措施: Vital signs (Procedure)
Placebo
干预措施: Urine pregnancy test (Procedure)
Placebo
干预措施: Completion of patient diary card (Procedure)
结局指标
主要结局
To measure levels of apoptosis in the normal colonic mucosa in subjects with a history of colonic adenomas, before and after treatment with EPA 99%.
时间窗: 3 months and 6 months
To measure levels of cell proliferation in the normal colonic mucosa in subjects with a history of colonic adenomas, before and after treatment with EPA 99%.
时间窗: 3 months and 6 months
次要结局
- To measure the tissue content of EPA in the colonic mucosa before, during and after treatment with EPA.(3 months and 6 months)
- To determine the safety and tolerability of EPA.(3 months and 6 months)