Cooking Education and Adapted Physical Activity in Allografted Patients (NUTRITION)

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

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.

Study Overview

• Status: Completed
• Conditions: Allograft
• Intervention / Treatment: Other: Cooking Education; Other: adapted physical activity

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France, 06200
    • CHU de Nice - Hôpital de l'Archet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cooking Education and adapted physical activity	Other: Cooking Education; cooking Education and adapted physical activity on patients after allo stem cell transplantation; Other: adapted physical activity; cooking Education and adapted physical activity on patients after allo stem cell transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index	Body mass index	at pre transplant
Body mass index	Body mass index	at Day 0
Body mass index	Body mass index	at Day 30
Body mass index	Body mass index	at Day 100
Body mass index	Body mass index	at Day 300
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
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
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
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
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
sit up test	sit up test	at pre transplant
sit up test	sit up test	at Day 0
sit up test	sit up test	at Day 30
sit up test	sit up test	at Day 100
sit up test	sit up test	at Day 300
bio electrical impedance analysis,	it's measuring the resistance of biological tissues	at pre transplant
bio electrical impedance analysis,	it's measuring the resistance of biological tissues	at Day 0
bio electrical impedance analysis,	it's measuring the resistance of biological tissues	at Day 30
bio electrical impedance analysis,	it's measuring the resistance of biological tissues	at Day 100
bio electrical impedance analysis,	it's measuring the resistance of biological tissues	at Day 300
hand grip	hand grip	at pre transplant
hand grip	hand grip	at Day 0
hand grip	hand grip	at Day 30
hand grip	hand grip	at Day 100
hand grip	hand grip	at Day 300

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life assessment,	it's a satisfaction patient's scale	at pre transplant
Quality of life assessment,	it's a satisfaction patient's scale	at Day 0
Quality of life assessment,	it's a satisfaction patient's scale	at Day 30
Quality of life assessment,	it's a satisfaction patient's scale	at Day 100
Quality of life assessment,	it's a satisfaction patient's scale	at Day 300
number of infections,	number of infections,	at pre transplant
number of infections,	number of infections,	at Day 0
number of infections,	number of infections,	at Day 30
number of infections,	number of infections,	at Day 100
number of infections,	number of infections,	at Day 300
number of graft versus host disease,	number of graft versus host disease,	at pre transplant
number of graft versus host disease,	number of graft versus host disease,	at Day 0
number of graft versus host disease,	number of graft versus host disease,	at Day 30
number of graft versus host disease,	number of graft versus host disease,	at Day 100
number of graft versus host disease,	number of graft versus host disease,	at Day 300
overall survival	overall survival	at pre transplant
overall survival	overall survival	at Day 0
overall survival	overall survival	at Day 30
overall survival	overall survival	at Day 100
overall survival	overall survival	at Day 300

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Thomas Cluzeau, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2019
• Primary Completion (Actual): May 9, 2022
• Study Completion (Actual): February 12, 2023

Study Registration Dates

• First Submitted: December 27, 2018
• First Submitted That Met QC Criteria: January 31, 2019
• First Posted (Actual): February 4, 2019

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Physical activity; Cooking; Allo Stem Cell Transplantation
• Other Study ID Numbers: 18-PP-10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No