ISRCTN28490479已完成不适用
tritional Support in Patients with newly diagnosed oEsophageal Cancer: a randomised, double blind, controlled clinical trial
Danone Research (Netherlands)0 个研究点目标入组 67 人开始时间: 2011年6月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Newly diagnosed with carcinoma of the oesophagus or gastro-oesophageal junction (Siewert-Stein classification type I - III)
- •2. Age more than or equal to 18 years
- •3. Written informed consent
- •Reference group (were included for baseline comparisons, no intervention in these subjects):
- •1. Age and sex-matched with the Dutch oesophagus cancer population
- •2. Written informed consent
- •3. Body mass index (BMI) 18.5-30 kg/m2
排除标准
- •1. Life expectancy < 3 months
- •2. Planned start of cancer treatment within 3 weeks
- •3. Eastern Cooperative Oncology Group (ECOG) performance status > 2
- •4. Any oesophagus related surgery after diagnosis before inclusion
- •5. Chemo- and/or radiotherapy in the past 5 years
- •6. Altered immune function [e.g. caused by major active infection, autoimmune disease, active allergy, rheumatoid arthritis, inflammatory bowel diseases, multiple sclerosis, or by use of medication such as immunosuppressive drugs, immunomodulators, or corticosteroids (unless not considered to be systemically available)]
- •7. Dysphagia score of 4 using the dysphagia scoring system
- •8. Dependence on tube feed or parenteral nutrition in the last 4 weeks
- •9. Use of fish oil containing supplements during the last 4 weeks
- •10. Intolerance or allergy to dairy, fish, or other ingredients of the study products
- •11. Dependency on fibre free diet
- •12. If pre-menopausal female: pregnant or lactating
- •13. Dementia or altered mental status that would prohibit the understanding and giving of informed consent
- •14. Any other medical condition that may interfere with the safety of the patient or the outcome parameters, in the investigator?s judgment.
- •15. Investigator?s uncertainty about the willingness or ability of the patient to comply with the protocol requirements (e.g. alcohol abuse)
- •Reference group (were included for baseline comparisons, no intervention in these subjects):
- •1. Significant involuntary weight loss in the past year
- •2. Smoking (defined as currently smoking or quit less than or equal to 6 months ago)
- •3. Acute or chronic disease
- •4. Altered immune function [e.g. caused by major active infection, autoimmune disease, active allergy, rheumatoid arthritis, inflammatory bowel diseases, multiple sclerosis, or by use of medication such as immunosuppressive drugs, immunomodulators, or corticosteroids (unless not considered to be systemically available)]
- •5. If pre-menopausal female: pregnant or lactating
- •6. Any other condition that may interfere with the definition ?healthy volunteer? according to the investigator?s judgement
研究者
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