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临床试验/NCT00459589
NCT00459589已完成不适用

Nutritional Intervention in Geriatric Oncology in Patients at Risk of Undernutrition

University Hospital, Bordeaux4 个研究点 分布在 1 个国家目标入组 341 人开始时间: 2007年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
341
试验地点
4
主要终点
Survival

研究概览

简要总结

Older patients with cancer are poorly treated or not treated at all. A previous study in the south west of France (364 patients) showed that patients receiving chemotherapy had short survival times which strongly depended on nutritional status. In this study, the researchers would like to evaluate if individual dietician follow-up at each cycle of chemotherapy increases survival of patients at risk of undernutrition.

详细描述

Undernutrition in patients with cancer also called tumour cachexia concerns about 50% of this population during tumour progression. It's well established that loss of weight is poor prognosis factor in patients treated by chemotherapy in digestive cancers. Small number of studies assessing undernutrition, its management and consequences on prognosis were published. Previous study lead by our team in oncogeriatry in Aquitaine accrued 364 patients more than 70 years old and treated by chemotherapy for cancer. Median follow-up at 13 months for intermediary analysis about 155 first patients revealed at first geriatric evaluation, 28 pts (18.7%) were malnourished (MNA<17) and 72 pts (48.0%) at risk of malnutrition (MNA 17 to 23.5). At one year median follow-up major mortality was observed in 20 (71.4%) undernourished patients, 34 (47.2%) patients at risk of undernutrition and 13 (26.0%) patients without nutritional problem. According to consensus undernourished patients received nutritional support. Management of patients at risk of malnutrition is not clear. Our hypothesis is that nutritional support in patients at risk of undernutrition detected during geriatric evaluation could increase survival, safety, functional status and quality of life of patients. We construct an open multicentric two group randomized trial comparing usual nutritional management versus usual nutritional management plus nutritional intervention with dietician at each cycle of chemotherapy in 6 first cycles to maintain 30 kcal/kg/d and 1.2 protein/kg/d. Principal objective is to increase survival at 1 year with 10%. According to O'Brien and Fleming method we have to include 410 pts in each group, about 1640 pts will be evaluated by MNA test.

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
None

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over 70 years of age
  • Histologically proven cancer
  • Treatment by chemotherapy
  • Risk of undernutrition according to MNA score between 17 and 23.5
  • Life expectancy > 12 weeks
  • Patient affiliated with the French social security regimen
  • Written informed consent

排除标准

  • MNA score under 17 or over 23.5
  • Geographic, psychological, or social conditions potentially hampering compliance with the study protocol
  • Symptomatic central nervous system (CNS) metastases
  • Chemotherapy treatments not published as standard protocols
  • Treatment that does not allow geriatric evaluation and dietician follow-up.

结局指标

主要结局

Survival

时间窗: 1 year

次要结局

  • mood (GDS-15)(before and after treatment)
  • biology (C-reactive protein [CRP], albumin, haemoglobin, creatinine clearance)(before and after treatment)
  • Survival(2 years)
  • toxicity of chemotherapy (NTC CTCv3 scale)(within 6 cycles of chemotherapy treatment,)
  • quality of life(before and after chemotherapy treatment)
  • function: IADL, ADL, get up and go test(before and after treatment)
  • weight(before and after treatment)
  • MNA(before and after treatment)
  • dietary intakes(before and after treatment)
  • hospitalisation frequency(during treatment)
  • opportunistic infection frequency(during treatment)
  • fall, breaks, pressure sore(during treatment)
  • death(during treatment and at 2 years)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (4)

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