NCT01025167已完成不适用
The Effect of a New Specific Enteral Formula Compared to a Standard Formula on the Tolerability of a Combined Radio- and Chemotherapy in Cancer Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 20
- 主要终点
- Body cell mass measured by bioelectrical impedance spectroscopy (BIS)
研究概览
简要总结
The purpose of the study is to determine the impact of a specific nutrition formula with a high content of eicosapentaenoic acid (EPA) and fat in oncology patients receiving radio-/chemotherapy on body weight, body composition, nutritional status and physical function compared to a standard nutrition formula. Using an adaptive design approximately 80 patients will be randomized in the first part of the study. Following an interim analysis further 160 patients may be added, for a total of 240 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •patients with head & neck cancer or oesophagus cancer,
- •enteral nutrition with PEG at least for 14 weeks,
- •cancer patients who receive a combined radio-/chemotherapy,
- •start of nutritional therapy latest at beginning of the radio-/chemotherapy, body mass index >=16 and <=30 kg/m2,0
- •Kondrup Score>=3 or SGA = B/C,
- •life expectancy > 6 months,
- •written informed consent.
排除标准
- •second active carcinoma,
- •severe diarrhea unresponsive to codeine/loperamide,
- •positive anti-HIV-test (safety reasons),
- •pregnant or lactating women,
- •insulin-dependent diabetes mellitus type I and II,
- •patients with cardiac pacemaker,
- •allergy to contents of the investigational product, to milk protein or to fish oil,
- •patient has no PEG,
- •participation in concurrent clinical studies with any other investigational nutritional therapy within one months prior to start of the study,
- •intake of muscle growth supportan substances (e.g. anabolics),
- •additional fish oil or EPA substitution within the last 4 weeks, SGA status A (well nourished).
结局指标
主要结局
Body cell mass measured by bioelectrical impedance spectroscopy (BIS)
时间窗: Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period
次要结局
- Other parameters of body composition such as fat free mass, lipid mass, total body water, intracellular water, lean tissue mass(Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period)
- Hand grip strength(Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period)
- Quality of Life(Baseline, end of radio-/chemotherapy, day 49 of convalescence period)
- Gastrointestinal tolerance(Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period, daily)
研究者
研究点 (20)
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