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临床试验/NCT03829072
NCT03829072已完成不适用

Impact of Cooking Education and Adapted Physical Activity on Nutritional Status and Quality of Life of Patients Treated by Allo Stem Cell Transplantation

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年3月21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
25
试验地点
2
主要终点
Body mass index

研究概览

简要总结

Majority of patients after allo stem cell transplantation have malnutrition and decrease of physical activities. This state impacts on quality of life and on outcome of some complications like infections, graft versus host disease and could decrease the overall survival. In this study, the investigators propose cooking education and adapted physical activity to improve that. Cooking education and adapted physical activity at home will be performed by two famous chefs for the first one and by a sportive coach for the second every twice week.

详细描述

Bone marrow transplantation is the main strategy to cure leukemia and others hematopoietic malignancies. It includes a first step of chemotherapy during several days (combined sometimes to radiotherapy), a second step of stem cells infusion and a third step of management of complications during several months: side effects, infections or graft versus host disease (GvHD). Symptoms are cutaneous, hepatic and digestive (nausea, diarrhea, vomiting) and could be unfortunately followed by the death of the patients.

Nutritional status is known to be important during the treatment of all cancers. After bone marrow transplantation, patients could have some digestive disorders that could induce malnutrition that could have an impact of time of hospitalization, intensity of complications and outcome of these ones.

When patients go back home after allo stem cell transplantation, they take several medicines, they have digestive side effects of past treatments could alter mucous, taste and all digestive tracts. During at least 100 days, patients take immunosuppressive therapies and they are going to develop new immune system. Therefore, they must follow some food rules to avoid infectious diseases. Patients feel some difficulties to eat good food and refuse often social activities. All of these have an impact on quality of life and induce an increase of malnutrition observed already directly after allo stem cell transplantation. Some complications could also increase malnutrition like digestive GvHD or digestive infections. Malnutrition could also induce physical troubles. Patients need until one year to recover physical conditions before the disease.

The aims of the study are to improve nutritional status and physical activity of patients after allo stem cell transplantation.

The investigators propose at all patients included in the study cooking education and adapted physical activity every twice week in alternance. Cooking education will be performed by two famous chefs in their kitchens. Patients (until 3 months after bone marrow transplantation) and one member of their family are invited to cook and taste. They will receive lot of advice to make several recipes at home and will adapt their cooking methods to respect food rules. Adapted physical activity will be performed by a sportive coach at home. The coach will give them some physical exercises to do between two sessions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

  • Patient at least 18 years old
  • Having been an allograft of CSH
  • Patient having read and understood the information note related to the study, and signed the informed consent form.

排除标准

  • Patient requiring nutritional support by enteral or parenteral route at J30
  • Follow-up of the patient considered difficult by the investigator.
  • Patient with a linguistic or psychic disability to understand the information.
  • Vulnerable patient under legal protection

结局指标

主要结局

Body mass index

时间窗: at Day 300

Body mass index

visual analogic scale of appetite

时间窗: at Day 300

It allows a visual assessment, by the patient himself, of his food intake, using an analog scale, or a choice of portions consumed.Visual analog scales (VAS) are reliable tools to evaluate hunger and satiety at point of food consumption. Score from 1 to 10. There are not better or worse values

sit up test

时间窗: at Day 300

sit up test

hand grip

时间窗: at Day 300

hand grip

bio electrical impedance analysis,

时间窗: at Day 300

it's measuring the resistance of biological tissues

次要结局

  • Quality of life assessment,(at Day 300)
  • number of infections,(at Day 300)
  • number of graft versus host disease,(at Day 300)
  • overall survival(at Day 300)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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