N-3 Fatty Acid EPA Supplementation in Cancer Patients Receiving Abdominal Radiotherapy - A Randomised Controlled Trial.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Change in weight (%)
研究概览
简要总结
Malnutrition occurs frequently in patients with cancer during and after radiotherapy to the gastrointestinal (GI) area and can lead to negative outcomes. N-3 fatty acids from fish, especially eicosapentaenoic acid (EPA) may possess anticachectic properties. The aim of this study is to investigate the effect of two nutritional interventions; dietary counselling and an oral nutritional supplement (ONS) containing 2.2 g of the n-3 fatty acid EPA (Forticare®) or standard care, including dietary counselling and protein supplementation when needed.
详细描述
Methods: Outpatients commencing radiotherapy to the GI area due to dissiminated cancer are randomized to receive dietary counselling and daily fish-oil supplementation over a 5-7 week period, or standard care. Outcome parameters are measured at baseline (onset of radiotherapy), week 5, and 12 weeks after commencing radiotherapy, with one additional measurement of body weight at week 2. Quality of life (QoL) is measured using the EORTC QLQ-C30 questionnaire. Radiotherapy-related side effects are assessed using a questionnaire developed specifically for this study. Data from a historical control group collected in a previous observational study is included in this study to compare incidence of weight loss.
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
- None
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
- •referred to radiotherapy for dissminated, abdominal cancer
- •> 18 years of age
- •able to understand and comply with the intervention
- •willingness to participate after oral and written conscent
排除标准
- •conditions precluding evaluations of end-points
- •operations planned in the observation period
结局指标
主要结局
Change in weight (%)
时间窗: 6 weeks
accumulated weight-loss or gain in per cent of the weight measured between baseline, end of treatment and at follow-up
次要结局
- energy intake (kJ/day) in % of estimated needs(6 weeks)
- Quality of life score (EORTC QLQ-C30 version 3.0) points(6 weeks)
- treatment-related side-effects (VAS) scale(6 weeks)
- protein intake (g/kg body weight/day) in % of estimated needs(6 weeks)
研究者
Jens Rikardt Andersen
Sponsor - Investigator
University of Copenhagen