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临床试验/NCT01687335
NCT01687335已完成不适用

Conformity With European Recommendations Concerning the Nutritional Care of the Cancerous Patients Benefiting From a Treatment by Chemotherapy Impact on the Nutritional State and the Quality of Life

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2012年6月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
102
试验地点
1
主要终点
improvement of their survival

研究概览

简要总结

The prevalence of malnutrition in cancerous patients varies between 50% and 80%. It is variable in function: the location and the extension of the tumor, of the general state , of age, of the socio-economic class and the pain. The health consequences of a malnutrition are very important: aggravation of the state of health, complications of treatment, hospitalization, alteration of the quality of life and decrease the survival, and the treatment response.

Nutrition being very important in patients, there are recommendations for the nutritional care of these patients, formulated by the European Society for Clinical Nutrition and Metabolism. The investigators do not know to what extent these recommendations are respected in practice and their influence on the nutritional status and the quality of life of patients.

The investigators therefore propose to assess the conformity of the nutritional care patients in clinical practice in relation to the European recommendations and in a second time to assess the influence of this compliance or non-compliance on the nutritional status clinical and biological of cancerous patients under chemotherapy, on their quality of life, on their response to treatment and on their survival.

The investigators will try to identify factors that may be linked to the non-compliance such as the characteristics of the cancer disease, socio-demographic characteristics of the subject and the factors related to the structure in which it is supported.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-year-old subject in 85 years in the inclusion
  • Subject presenting a cancerous pathology requiring a systematic treatment by exclusive chemotherapy for a minimal duration of three months with a plan of 3 cures of chemotherapy with an interval between the cures of 21 days
  • Presenting subject one of these 4 cancerous pathologies: cancer of the aéro-digestive ways superiors, sarcomas, colorectal cancers, broncho-lung cancers
  • Subject having the capacity of lira and to understand(include) French
  • Subject having signed lit(enlightened) consent
  • Subject taken care for its cancerous pathology in one of the partner services of the project
  • Subject affiliated to the national insurance scheme

排除标准

  • Subject having benefited from a major surgical operation in 4 weeks preceding the inclusion
  • Subject having benefited from a radiotherapy in two weeks before the inclusion
  • Subject minor(miner), pregnant woman, subject incapable to give its consent, subject under supervision(guardianship) - guardianship

结局指标

主要结局

improvement of their survival

时间窗: 3 YEARS

quality of life's improvement

时间窗: 3 YEARS

improvement of treatment effectiveness,

时间窗: 3 YEARS

次要结局

  • the answer to the treatment(3 years)
  • improvement of the screening of the undernutrition(3 YEARS)
  • the estimation of the survival with regard to the nutritional state of the patient.(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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