Cooking Education and Adapted Physical Activity in Allografted Patients

Allograft Clinical Trial

— NUTRITION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03829072
• Other study ID #: 18-PP-10
• Status: Completed
• Phase: N/A
• Start date: March 21, 2019
• Est. completion date: February 12, 2023

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Allograft

Intervention

Other:
• Cooking Education
cooking Education and adapted physical activity on patients after allo stem cell transplantation
• adapted physical activity
cooking Education and adapted physical activity on patients after allo stem cell transplantation

Locations

Country	Name	City	State
France	CHU de Nice - Hôpital de l'Archet	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

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