Allograft Clinical Trial
— NUTRITIONOfficial title:
Impact of Cooking Education and Adapted Physical Activity on Nutritional Status and Quality of Life of Patients Treated by Allo Stem Cell Transplantation
Verified date | February 2024 |
Source | Centre Hospitalier Universitaire de Nice |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | February 12, 2023 |
Est. primary completion date | May 9, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU de Nice - Hôpital de l'Archet | Nice |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nice |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body mass index | Body mass index | at pre transplant | |
Primary | Body mass index | Body mass index | at Day 0 | |
Primary | Body mass index | Body mass index | at Day 30 | |
Primary | Body mass index | Body mass index | at Day 100 | |
Primary | Body mass index | Body mass index | at Day 300 | |
Primary | visual analogic scale of appetite | 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. | at pre transplant | |
Primary | visual analogic scale of appetite | 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 | at Day 0 | |
Primary | visual analogic scale of appetite | 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 | at Day 30 | |
Primary | visual analogic scale of appetite | 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 | at Day 100 | |
Primary | visual analogic scale of appetite | 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 | at Day 300 | |
Primary | sit up test | sit up test | at pre transplant | |
Primary | sit up test | sit up test | at Day 0 | |
Primary | sit up test | sit up test | at Day 30 | |
Primary | sit up test | sit up test | at Day 100 | |
Primary | sit up test | sit up test | at Day 300 | |
Primary | bio electrical impedance analysis, | it's measuring the resistance of biological tissues | at pre transplant | |
Primary | bio electrical impedance analysis, | it's measuring the resistance of biological tissues | at Day 0 | |
Primary | bio electrical impedance analysis, | it's measuring the resistance of biological tissues | at Day 30 | |
Primary | bio electrical impedance analysis, | it's measuring the resistance of biological tissues | at Day 100 | |
Primary | bio electrical impedance analysis, | it's measuring the resistance of biological tissues | at Day 300 | |
Primary | hand grip | hand grip | at pre transplant | |
Primary | hand grip | hand grip | at Day 0 | |
Primary | hand grip | hand grip | at Day 30 | |
Primary | hand grip | hand grip | at Day 100 | |
Primary | hand grip | hand grip | at Day 300 | |
Secondary | Quality of life assessment, | it's a satisfaction patient's scale | at pre transplant | |
Secondary | Quality of life assessment, | it's a satisfaction patient's scale | at Day 0 | |
Secondary | Quality of life assessment, | it's a satisfaction patient's scale | at Day 30 | |
Secondary | Quality of life assessment, | it's a satisfaction patient's scale | at Day 100 | |
Secondary | Quality of life assessment, | it's a satisfaction patient's scale | at Day 300 | |
Secondary | number of infections, | number of infections, | at pre transplant | |
Secondary | number of infections, | number of infections, | at Day 0 | |
Secondary | number of infections, | number of infections, | at Day 30 | |
Secondary | number of infections, | number of infections, | at Day 100 | |
Secondary | number of infections, | number of infections, | at Day 300 | |
Secondary | number of graft versus host disease, | number of graft versus host disease, | at pre transplant | |
Secondary | number of graft versus host disease, | number of graft versus host disease, | at Day 0 | |
Secondary | number of graft versus host disease, | number of graft versus host disease, | at Day 30 | |
Secondary | number of graft versus host disease, | number of graft versus host disease, | at Day 100 | |
Secondary | number of graft versus host disease, | number of graft versus host disease, | at Day 300 | |
Secondary | overall survival | overall survival | at pre transplant | |
Secondary | overall survival | overall survival | at Day 0 | |
Secondary | overall survival | overall survival | at Day 30 | |
Secondary | overall survival | overall survival | at Day 100 | |
Secondary | overall survival | overall survival | at Day 300 |
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