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临床试验/NCT02921646
NCT02921646终止不适用

Monocentric, Prospective Study Assessing the Feasibility to Use Resting Energy Expenditure by Indirect Calorimetry as Prognostic Marker of Tumoral Response to 1st Line Chemotherapy in Patients Suffering From Metastatic Pancreatic Cancer

Center Eugene Marquis2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2017年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
8
试验地点
2
主要终点
Resting energetic expenditure measurement by indirect calorimetry

研究概览

简要总结

The purpose of this study is to determine whether evolution of resting energetic expenditure is a predictive marker of tumoral response for patients suffering from metastatic pancreatic cancer and treated with 1st line of chemotherapy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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

  • Pancreatic metastatic cancer
  • Patient older than 18 years
  • Initiation of a first line of chemotherapy by Folfirinox, or Gemcitabine or in combination with Nab-Paclitaxel.
  • At least one measurable target lesion
  • Patient signed consent for Energie-Pancreas study participation

排除标准

  • Other concomitant cancer
  • Major general status alteration ( Performance status = 3 or 4 at inclusion)
  • Concomitant diseases explaining an altered general status or having an impact on energetic expenditure (i.e.chronic or severe infection, severe cardiac insufficiency, severe respiratory insufficiency, chronic inflammatory disease, recent surgery (< 1 month), ongoing Healing, hyperthyroidism.
  • Patient deprived of his liberty, under guardianship, curator.
  • Pregnant patient or breastfeeding
  • Claustrophobic patient

结局指标

主要结局

Resting energetic expenditure measurement by indirect calorimetry

时间窗: 4 months

Unit measure : calorie per day

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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