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临床试验/NCT03751384
NCT03751384已完成不适用

Fish Oil Supplementation in Cancer Patients - Capsules or in Nutritional Supplements. A Controlled Trial of Compliance.

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2015年5月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
2
主要终点
Compliance

研究概览

简要总结

Several studies indicate beneficial effects of eicosapentanoic acid (EPA) on cancer cachexia. However, compliance is generally low. This case control study is conducted in order to investigate if compliance depends upon the physical properties of the supplement (capsules vs. drinks). In order to further investigate how compliance can be improved, a possible correlation between sideeffects and rate of increased polyunsaturated fatty acid concentration in blood is also tested

详细描述

Patients with abdominal cancer in active chemotherapeutic were allocated to either EPA in an oral nutritional drink (commercial) or capsules with fish oil. The dose of EPA was the same in both groups, and diets were adjusted as iso-caloric. Compliance to the fish oil treatment was the primary outcome. Blood concentrations of EPA secondary.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

pseudo-anonymized

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients receiving chemotherapy on Rigshospitalet due to colorectal cancer
  • Not terminally ill
  • Subjects must be18 years of age (or older)

排除标准

  • Subjects who do not read/speak/understand Danish
  • Familial hypercholesterolemia
  • Predialytic patients (GFR < 15 ml/min/1,73 m2 or creatinine ≥ 500 mmol/L)
  • Use of blood thinners
  • Bleeder's disease

研究组 & 干预措施

Capsules

Experimental

Dietary Supplement: Möllers Omega-3 Ekstra Sterk

干预措施: Möllers Omega-3 Ekstra Sterk (Dietary Supplement)

Drink

Active Comparator

Dietary Supplement: Nutrifriend Cachexia

干预措施: Nutrifriend Cachexia (Dietary Supplement)

结局指标

主要结局

Compliance

时间窗: 4 weeks

Number of Capsules and bottles counted

次要结局

  • Erythrocyte concentration of EPA(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jens Rikardt Andersen

Associated Professor

University of Copenhagen

研究点 (2)

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