NCT01423799已完成3 期
Immunonutrition to Improve Quality of Life of Upper Gastrointestinal Cancer Patients Undergoing Oncological Treatment
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2012年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Quality of Life (QOL), measured with the EORTC QLQ-C30
研究概览
简要总结
The purpose of this study is to compare the health-related quality of life following dietary supplementation with an immunonutrition formulation vs an isocaloric/isoprotein control diet supplement in patients suffering from upper digestive tract neoplasia undergoing oncological treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven GI cancer.
- •Age ≥ 18 years.
- •Life expectancy more than 3 months.
- •Female patients of child-bearing potential must be willing to employ effective contraception during the study period.
- •Female patients of child-bearing potential must have a negative serum Beta Human Chorionic Gonadotrophin (βhCG) test at Visit
- •The patient is able to communicate effectively with study personnel and is considered reliable, willing, and cooperative in terms of compliance with the protocol requirements.
- •The patient voluntarily gives written informed consent to participate in the study.
排除标准
- •Severe concomitant clinical conditions other than the previously untreated digestive tract cancer that jeopardise the protocol follow-up.
- •The patient is pregnant or is a lactating woman.
- •Currently participating or having participated in another interventional clinical trial related to nutritional support during the 30 days prior to the beginning of the study product intake, except if this other interventional trial is testing new drug or surgical intervention. (Note: participation in a prior or concurrent clinical trial not related to nutritional support does not exclude the patient from participation.)
- •Other malignancies in the last 5 years (except for successfully treated in situ basocellular skin and in situ cervical uterine tumours).
- •Patients with more than 20% weight loss over a 6 months period.
研究组 & 干预措施
Nutritional product
Experimental
Nutritional intervention containing immuno-nutrients
干预措施: Nutritional supplements containing arginine, n-3 and nucleotides (Dietary Supplement)
Control Group
Active Comparator
Isocaloric and isonitrogenous control without immuno nutrients.
干预措施: Isocaloric control (Dietary Supplement)
结局指标
主要结局
Quality of Life (QOL), measured with the EORTC QLQ-C30
时间窗: QOL will me measured 30 days post-surgery
次要结局
- QOL assessed by the EORTC QLQ-OG 25(QOL will me measured 30 days post-surgery)
研究者
研究点 (2)
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