跳至主要内容
临床试验/NCT03632200
NCT03632200招募中不适用

Improvement of the Nutritional Course of Care After Surgical Treatment at the Patients Affected by a Cancer of the Head and by the Neck

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年3月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
The satisfactory nutritional state defined by the absence of loss of weight

研究概览

简要总结

Whatever are the strategies of coverage, the consideration of the state of bad nutrition is not often the priority. According to the last recommendations (2012) of the French Society Clinical Nutrition and Metabolism (SFNEP), the surgeries of the cancers of the VADS are not listed among surgeries with high morbidity. So the specific recommendations for the patients undernourished with surgery with low morbidity, only a personalized dietary advice and oral nutritional supplements are recommended in preoperative. There is no specific recommendation in post-operative.

Two groups of cancer patients of the VADS will be compared: a control group benefiting from a nutritional coverage based on the current recommendations of the SFNEP, an experimental group benefiting from an improved nutritional coverage.

In preoperative, all the patients of experimental group will benefit from dietary advice during a multidisciplinary specific consultation. In post-operative, a dietetic consultation will be set up in 7 days at the exit of hospitalization and call phone at M1, M2, M4 and M5. And for the undernourished patient will benefit a multidisciplinary consultation at the rate of a consultation a month during 6 months.

In the Group control, the patients will be followed according to the current recommendations of the SFNEP.

详细描述

Whatever are the strategies of coverage, the consideration of the state of bad nutrition is not often the priority. According to the last recommendations (2012) of the French Society Clinical Nutrition and Metabolism (SFNEP), the surgeries of the cancers of the VADS are not listed among surgeries with high morbidity. So the specific recommendations for the patients undernourished with surgery with low morbidity, only a personalized dietary advice and oral nutritional supplements are recommended in preoperative. There is no specific recommendation in post-operative.

Two groups of cancer patients of the VADS will be compared: a control group benefiting from a nutritional coverage based on the current recommendations of the SFNEP, an experimental group benefiting from an improved nutritional coverage.

In preoperative, all the patients of experimental group will benefit from dietary advice during a multidisciplinary specific consultation. In post-operative, a dietetic consultation will be set up in 7 days at the exit of hospitalization and call phone at M1, M2, M4 and M5. And for the undernourished patient will benefit a multidisciplinary consultation at the rate of a consultation a month during 6 months.

In the Group control, the patients will be followed according to the current recommendations of the SFNEP.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients affected by a cancer of the VADS
  • Man or woman of 18 and more years old
  • Patient benefiting from a surgery for its cancer of the VADS
  • Patient having signed a written consent
  • Patient member in a national insurance scheme

排除标准

  • Patient minor
  • Patient benefiting from a radiotherapy
  • Patient participant in another research interfering on the nutritional state of the patient
  • Patients under guardianship or guardianship

研究组 & 干预措施

Experimental group

Experimental

The patients with a cancer of the VADS: in preoperative, all the patients will benefit from dietary advice during a multidisciplinary specific consultation (physiotherapist, dietician, nursing staff CMF). The accent will be put on the adaptations of the diet, the complementary nutritional contributions, the assistants in "better to eat".

In post-operative, a dietetic consultation will be set up in 7 days at the post hospitalization and rate call phone at M1, M2, M4 and M5.

The undernourished patient will benefit besides a multidisciplinary consultation at the rate of a consultation a month during 6 months according to the same conditions.

干预措施: Experimental group (Other)

Control group

No Intervention

The patients will be followed according to the current recommendations of the French Society Clinical Nutrition and Metabolism (SFNEP).

结局指标

主要结局

The satisfactory nutritional state defined by the absence of loss of weight

时间窗: 6 months

weight loss difference equal to 0 between the time 0 and the 6th month

次要结局

  • The score PG-SGA (index of Detsky)(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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