Clinical trial NCT03829072: Cooking Education and Adapted Physical Activity in Allografted Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allograft
Keywords: Allo Stem Cell Transplantation
Cooking
Physical activity
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Body mass index
timeFrame: at pre transplant
measure: Body mass index
timeFrame: at Day 0
measure: Body mass index
timeFrame: at Day 30
measure: Body mass index
timeFrame: at Day 100
measure: Body mass index
timeFrame: at Day 300
measure: visual analogic scale of appetite
timeFrame: at pre transplant
measure: visual analogic scale of appetite
timeFrame: at Day 0
measure: visual analogic scale of appetite
timeFrame: at Day 30
measure: visual analogic scale of appetite
timeFrame: at Day 100
measure: visual analogic scale of appetite
timeFrame: at Day 300
measure: sit up test
timeFrame: at pre transplant
measure: sit up test
timeFrame: at Day 0
measure: sit up test
timeFrame: at Day 30
measure: sit up test
timeFrame: at Day 100
measure: sit up test
timeFrame: at Day 300
measure: bio electrical impedance analysis,
timeFrame: at pre transplant
measure: bio electrical impedance analysis,
timeFrame: at Day 0
measure: bio electrical impedance analysis,
timeFrame: at Day 30
measure: bio electrical impedance analysis,
timeFrame: at Day 100
measure: bio electrical impedance analysis,
timeFrame: at Day 300
measure: hand grip
timeFrame: at pre transplant
measure: hand grip
timeFrame: at Day 0
measure: hand grip
timeFrame: at Day 30
measure: hand grip
timeFrame: at Day 100
measure: hand grip
timeFrame: at Day 300
Secondary outcomes:
measure: Quality of life assessment,
timeFrame: at pre transplant
measure: Quality of life assessment,
timeFrame: at Day 0
measure: Quality of life assessment,
timeFrame: at Day 30
measure: Quality of life assessment,
timeFrame: at Day 100
measure: Quality of life assessment,
timeFrame: at Day 300
measure: number of infections,
timeFrame: at pre transplant
measure: number of infections,
timeFrame: at Day 0
measure: number of infections,
timeFrame: at Day 30
measure: number of infections,
timeFrame: at Day 100
measure: number of infections,
timeFrame: at Day 300
measure: number of graft versus host disease,
timeFrame: at pre transplant
measure: number of graft versus host disease,
timeFrame: at Day 0
measure: number of graft versus host disease,
timeFrame: at Day 30
measure: number of graft versus host disease,
timeFrame: at Day 100
measure: number of graft versus host disease,
timeFrame: at Day 300
measure: overall survival
timeFrame: at pre transplant
measure: overall survival
timeFrame: at Day 0
measure: overall survival
timeFrame: at Day 30
measure: overall survival
timeFrame: at Day 100
measure: overall survival
timeFrame: at Day 300
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice - Hôpital de l'Archet
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Thomas CLUZEAU
role: PRINCIPAL_INVESTIGATOR
References: