NCT01070355已完成2 期
The Effects of Eicosapentaenoic Acid (EPA) on Biomarkers of Growth and Vascularity in Human Colorectal Cancer Liver Metastases (The EPA for Metastasis Trial)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Histological Ki67 cancer cell proliferation index
研究概览
简要总结
Eicosapentaenoic acid (EPA) is a naturally occuring omega-3 polyunsaturated fatty acid found in oily fish. EPA has anti-colorectal (bowel) cancer activity in experimental models. This trial will test whether EPA reduces markers of tumour growth, and is safe and well tolerated,in patients with colorectal cancer liver metastases awaiting surgery.
详细描述
A double-blind, randomised, placebo-controlled trial of eicosapentaenoic acid (EPA), in the free fatty acid form, 2g daily in patients who will undergo liver resection surgery for colorectal cancer liver metastases.
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
- •Age greater than or equal to 18 years
- •Either sex
- •Liver resection deemed clinically appropriate for management of metastatic colorectal cancer
- •Duration between decision to perform liver resection and surgery greater than 2 weeks
- •Ability to give written informed consent and follow study protocol
- •Telephone contact possible
排除标准
- •Neo-adjuvant chemotherapy for colorectal cancer (CRC) liver metastasis
- •Chemotherapy for any cancer in the previous 3 months
- •Known bleeding diathesis or anticoagulation therapy
- •Fish or seafood allergy
- •Use of fish oil supplements (eg. cod liver oil) and unwilling to stop for the duration of the study
- •Pregnancy
- •Non-aspirin non-steroidal anti-inflammatory (NSAID) or corticosteroid use
- •Renal impairment (serum creatinine >150)
- •Active inflammatory disease (e.g. Inflammatory Bowel Disease, Rheumatoid Arthritis).
研究组 & 干预措施
Placebo
Placebo Comparator
2 capsules twice daily
干预措施: Placebo (Drug)
Eicosapentaenoic acid free fatty acid
Active Comparator
2g daily (2 x 500mg capsules twice daily)
干预措施: Eicosapentaenoic acid free fatty acid (Drug)
结局指标
主要结局
Histological Ki67 cancer cell proliferation index
时间窗: at surgery 2-6 weeks after randomisation
次要结局
- Histological neo-CK18 cancer cell apoptosis index(at surgery 2-6 weeks after randomisation)
- Histological tumour CD31-positive cell microvessel density(at surgery 2-6 weeks after randomisation)
- Safety and tolerability of EPA treatment(Every 2 weeks whilst patient is taking study medication)
- Metastatic tissue and healthy liver tissue fatty acid composition and prostaglandin levels(at surgery 2-6 weeks after randomisation)
- Plasma markers of prostaglandin metabolism(1. Baseline 2. after approx 4 weeks of study medication (immediately prior to surgery). 3. Six weeks after liver resection (no study medication))
- Platelet aggregation(1. Baseline 2. after approx 4 weeks of study medication (immediately prior to surgery). 3. Six weeks after liver resection (no study medication))
- Urinary markers of prostaglandin metabolism(1. Baseline 2. after 2 weeks of study medication 3. after approx 4 weeks of study medication (immediately prior to surgery). 4. Six weeks after liver resection (no study medication))
研究者
研究点 (1)
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