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临床试验/NCT00455247
NCT00455247已完成3 期

Efficacy of an Oral Formula in Prevention of Anti-cancer Therapy Side Effects

Société des Produits Nestlé (SPN)10 个研究点 分布在 1 个国家开始时间: 2007年10月1日最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
试验地点
10

研究概览

简要总结

Anti-cancer treatment is often inducing side-effects that can affect the compliance to the treatment protocol and quality of life of the patients. The researchers will study if the nutritional intervention with the product could abrogate the undesired effects in a preventive manner.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double

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

  • Patient with GI neoplasm
  • Patient that must start a (new) line of chemotherapy with at least 2 cycles
  • Age > 18 ans
  • Exclusively orally fed
  • Life expectancy more than 3 months
  • Intravenous 5FU-based chemotherapy with 2 or 3-week cycles
  • Hematological toxicities from previous chemotherapies terminated or <= 2

排除标准

  • Positive HIV status
  • Pregnant or lactating woman
  • Currently participating or having participated in another clinical trial during the last month prior to the beginning of this study
  • Patient having diarrhoea of grade > 1 for more than 2 weeks before the inclusion
  • State of sub occlusion, chronic inflammatory diseases of the digestive tract, radiation enteropathy
  • Concomitant radiotherapy, except analgesic radiotherapy

研究者

发起方
Société des Produits Nestlé (SPN)
申办方类型
Industry

研究点 (10)

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