CHU de Nice - Hôpital de l'Archet
Nice, 06200, France
NCT Number: NCT03829072
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Nice, 06200, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
cooking Education and adapted physical activity on patients after allo stem cell transplantation
cooking Education and adapted physical activity on patients after allo stem cell transplantation
Time frame: at pre transplant
Body mass index
Time frame: at Day 0
Body mass index
Time frame: at Day 30
Body mass index
Time frame: at Day 100
Body mass index
Time frame: at Day 300
Body mass index
Time frame: at pre transplant
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.
Time frame: at Day 0
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
Time frame: at Day 30
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
Time frame: at Day 100
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
Time frame: 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
Time frame: at pre transplant
sit up test
Time frame: at Day 0
sit up test
Time frame: at Day 30
sit up test
Time frame: at Day 100
sit up test
Time frame: at Day 300
sit up test
Time frame: at pre transplant
it's measuring the resistance of biological tissues
Time frame: at Day 0
it's measuring the resistance of biological tissues
Time frame: at Day 30
it's measuring the resistance of biological tissues
Time frame: at Day 100
it's measuring the resistance of biological tissues
Time frame: at Day 300
it's measuring the resistance of biological tissues
Time frame: at pre transplant
hand grip
Time frame: at Day 0
hand grip
Time frame: at Day 30
hand grip
Time frame: at Day 100
hand grip
Time frame: at Day 300
hand grip
Time frame: at pre transplant
it's a satisfaction patient's scale
Time frame: at Day 0
it's a satisfaction patient's scale
Time frame: at Day 30
it's a satisfaction patient's scale
Time frame: at Day 100
it's a satisfaction patient's scale
Time frame: at Day 300
it's a satisfaction patient's scale
Time frame: at pre transplant
number of infections,
Time frame: at Day 0
number of infections,
Time frame: at Day 30
number of infections,
Time frame: at Day 100
number of infections,
Time frame: at Day 300
number of infections,
Time frame: at pre transplant
number of graft versus host disease,
Time frame: at Day 0
number of graft versus host disease,
Time frame: at Day 30
number of graft versus host disease,
Time frame: at Day 100
number of graft versus host disease,
Time frame: at Day 300
number of graft versus host disease,
Time frame: at pre transplant
overall survival
Time frame: at Day 0
overall survival
Time frame: at Day 30
overall survival
Time frame: at Day 100
overall survival
Time frame: at Day 300
overall survival
Centre Hospitalier Universitaire de Nice
Other
Impact of Cooking Education and Adapted Physical Activity on Nutritional Status and Quality of Life of Patients Treated by Allo Stem Cell Transplantation
Acronym: NUTRITION
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