Cooking Education and Adapted Physical Activity in Allografted Patients
关键词
抽象
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.
Patients, aged more than 18 years old and signing the consent form, are included in the study before allo stem cell transplantation. Nutritional status evaluation will be performed by a nutritionist using some tests: sit up test, hand grip, bioelectrical impedance analysis, mid upper arm circumference, analogic evaluation of appetite, blood tests: C reactive protein, transthyretin, albumin. The nutritionist will analyze also body mass index, the weight loss percent, the subjective global assessment, the health quality of life assessment.
Evaluation will be performed before allo stem cell transplantation, at day 0, 30, 100 and 300.
The aims of the study are to observe an improvement of nutritional status, quality of life, a decrease of the number of infections and GvHD and at the end an increase of overall survival.
日期
| 最后验证: | 11/30/2018 |
| 首次提交: | 12/26/2018 |
| 提交的预估入学人数: | 01/30/2019 |
| 首次发布: | 02/03/2019 |
| 上次提交的更新: | 02/03/2019 |
| 最近更新发布: | 02/05/2019 |
| 实际学习开始日期: | 01/30/2019 |
| 预计主要完成日期: | 01/30/2020 |
| 预计完成日期: | 01/30/2022 |
状况或疾病
干预/治疗
Other: cooking Education and adapted physical activity
Other: cooking Education and adapted physical activity
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: cooking Education and adapted physical activity | Other: cooking Education and adapted physical activity cooking Education and adapted physical activity on patients after allo stem cell transplantation |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
结果
主要结果指标
1. Body mass index [at pre transplant]
2. Body mass index [at Day 0]
3. Body mass index [at Day 30]
4. Body mass index [at Day 100]
5. Body mass index [at Day 300]
6. visual analogic scale of appetite [at pre transplant]
7. visual analogic scale of appetite [at Day 0]
8. visual analogic scale of appetite [at Day 30]
9. visual analogic scale of appetite [at Day 100]
10. visual analogic scale of appetite [at Day 300]
11. sit up test [at pre transplant]
12. sit up test [at Day 0]
13. sit up test [at Day 30]
14. sit up test [at Day 100]
15. sit up test [at Day 300]
16. bio electrical impedance analysis, [at pre transplant]
17. bio electrical impedance analysis, [at Day 0]
18. bio electrical impedance analysis, [at Day 30]
19. bio electrical impedance analysis, [at Day 100]
20. bio electrical impedance analysis, [at Day 300]
21. hand grip [at pre transplant]
22. hand grip [at Day 0]
23. hand grip [at Day 30]
24. hand grip [at Day 100]
25. hand grip [at Day 300]
次要成果指标
1. Quality of life assessment, [at pre transplant]
2. Quality of life assessment, [at Day 0]
3. Quality of life assessment, [at Day 30]
4. Quality of life assessment, [at Day 100]
5. Quality of life assessment, [at Day 300]
6. number of infections, [at pre transplant]
7. number of infections, [at Day 0]
8. number of infections, [at Day 30]
9. number of infections, [at Day 100]
10. number of infections, [at Day 300]
11. number of graft versus host disease, [at pre transplant]
12. number of graft versus host disease, [at Day 0]
13. number of graft versus host disease, [at Day 30]
14. number of graft versus host disease, [at Day 100]
15. number of graft versus host disease, [at Day 300]
16. overall survival [at pre transplant]
17. overall survival [at Day 0]
18. overall survival [at Day 30]
19. overall survival [at Day 100]
20. overall survival [at Day 300]
