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临床试验/NCT04208334
NCT04208334已完成2 期

A Double-blind, Placebo-controlled Randomized Trial Phase II Evaluating the Effect of Curcumin for Treatment of Cancer Anorexia-Cachexia Syndrome in Patients With Stage III-IV of Head and Neck Cancer

Phramongkutklao College of Medicine and Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年2月13日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Muscle mass

研究概览

简要总结

A study of Curcumin to prevent cancer anorexia and cachexia Syndrom in locally advance and advance stage head and neck cancer (stage III, IV)

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
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

入选标准

  • Head and neck cancer stage III-IV
  • Cancer anorexia cachexia syndrome by 2011 Cancer cachexia an International Consensus
  • Enteral feeding with Nasogastric Tube or Gastrostomy
  • Normal Bone marrow, kidneys, and liver function
  • Normal function of enteral digestion and absorption

排除标准

  • Pregnancy
  • History of allergy to Curcumin or herbal medicine
  • History of Herbal medicine used
  • History of Billiary of obstruction
  • History of Antiplatelete or anticoagulant.

结局指标

主要结局

Muscle mass

时间窗: 60 days after intervention

We measure muscle mass by Bioelectrical Impedance Analysis (BIA)

次要结局

  • BMI(60 days after intervention)
  • Hand grips muscle strength(60 days after intervention)
  • serum NF-kB level(60 days after intervention)

研究者

发起方
Phramongkutklao College of Medicine and Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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