Fish Oil and Evening Primrose Oil in the Treatment of Breast Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Change in quality of life
研究概览
简要总结
Recent literature data suggest beneficial effects of dietary fats in patients with cancers, in particular polyunsaturated fatty acids (PUFAs). Fish oil and evening primrose oil provide a high amount of PUFAs and a desirable n-6/n-3 PUFAs ratio.
详细描述
Breast cancer (BC) is leading cancer in women. As most of the cancers, it is characterized by inflammation and alternations in lipid and fatty acid metabolism. Patients with BC have impaired fatty acid profiles, low level of PUFAs, and high n-6/n-3 PUFAs ratio. Moreover, these changes are related to clinical outcome.
Fish oil is the richest source of anti-inflammatory n-3 PUFAs. Evening primrose oil (EPO) is rich in 18:3 n-6, the only n-6 fatty acid with an anti-inflammatory effect. Dietary intake of fish oil or EPO has been shown to decrease inflammation and improve PUFAs status in patients with cancers. However, it is not known what is the effect of combined EPO and fish oil in BC patients.
The study design is double-blind, controlled, randomized nutritional intervention. The participants are randomly assigned into intervention and control group before starting chemotherapy. All patients receive nutritional counseling to achieve a daily energy and protein intake according to recommended dietary allowances, with (intervention) or without (control) of milled seed mix.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double blind
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed breast cancer,
- •Clinical Stadium III and IV,
- •Patients able to understand requirements of the study and provide written informed consent-
排除标准
- •Previous radio- or chemotherapy
- •Other serious chronic diseases
- •Statin therapy
- •Use of fat-based dietary supplements (such as fish oil, evening primrose oil etc) 3 months prior to study
结局指标
主要结局
Change in quality of life
时间窗: Baseline, 3 months, 1 year
Assessed by standardized questionnaires, scale 1-4 (1-not at all, 2- a little, 3 - quite a bit, 4- very much), higher value represents worse outcome.
Change in disease status
时间窗: Baseline, 3 months, 1 year
Remission, stable disease or progression
次要结局
- Changes in plasma fatty acids profiles(Baseline, 3 months, 1 year)
- Changes in interleukins(Baseline, 3 months, 1 year)
- Changes in activity of superoxide dismutase.(Baseline, 3 months, 1 year)
- Changes in nutritional status(Baseline, 3 months, 1 year)
- Changes in activity of glutathion peroxidase.(Baseline, 3 months, 1 year)
- Changes in lipid profiles(Baseline, 3 months, 1 year)
- Changes in activity of catalase.(Baseline, 3 months, 1 year)
- Changes in activity of glutathion reductase.(Baseline, 3 months, 1 year)
研究者
Aleksandra Arsic
Research Associate Professor
University of Belgrade