Cooking Education and Adapted Physical Activity in Allografted Patients

NCT ID: NCT03829072

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-21
• Study Completion Date: 2023-02-12

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.

Conditions

Allograft

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

cooking Education and adapted physical activity

Group Type: EXPERIMENTAL

Cooking Education

Intervention Type: OTHER

cooking Education and adapted physical activity on patients after allo stem cell transplantation

adapted physical activity

Intervention Type: OTHER

cooking Education and adapted physical activity on patients after allo stem cell transplantation

Interventions

Cooking Education

cooking Education and adapted physical activity on patients after allo stem cell transplantation

Intervention Type: OTHER

adapted physical activity

cooking Education and adapted physical activity on patients after allo stem cell transplantation

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas CLUZEAU

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

CHU de Nice - Hôpital de l'Archet

Nice, , France

Countries

France

Other Identifiers

18-PP-10

Identifier Type: -

Identifier Source: org_study_id