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Completed

NCT Number: NCT03829072

Cooking Education and Adapted Physical Activity in Allografted Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice - Hôpital de l'Archet

Nice, 06200, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cooking Education

Other

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

adapted physical activity

Other

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

Primary outcomes

  1. Body mass index

    Time frame: at pre transplant

    Body mass index

  2. Body mass index

    Time frame: at Day 0

    Body mass index

  3. Body mass index

    Time frame: at Day 30

    Body mass index

  4. Body mass index

    Time frame: at Day 100

    Body mass index

  5. Body mass index

    Time frame: at Day 300

    Body mass index

  6. visual analogic scale of appetite

    Time frame: at pre transplant

    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.

  7. visual analogic scale of appetite

    Time frame: at Day 0

    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

  8. visual analogic scale of appetite

    Time frame: at Day 30

    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

  9. visual analogic scale of appetite

    Time frame: at Day 100

    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

  10. visual analogic scale of appetite

    Time frame: at Day 300

    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

  11. sit up test

    Time frame: at pre transplant

    sit up test

  12. sit up test

    Time frame: at Day 0

    sit up test

  13. sit up test

    Time frame: at Day 30

    sit up test

  14. sit up test

    Time frame: at Day 100

    sit up test

  15. sit up test

    Time frame: at Day 300

    sit up test

  16. bio electrical impedance analysis,

    Time frame: at pre transplant

    it's measuring the resistance of biological tissues

  17. bio electrical impedance analysis,

    Time frame: at Day 0

    it's measuring the resistance of biological tissues

  18. bio electrical impedance analysis,

    Time frame: at Day 30

    it's measuring the resistance of biological tissues

  19. bio electrical impedance analysis,

    Time frame: at Day 100

    it's measuring the resistance of biological tissues

  20. bio electrical impedance analysis,

    Time frame: at Day 300

    it's measuring the resistance of biological tissues

  21. hand grip

    Time frame: at pre transplant

    hand grip

  22. hand grip

    Time frame: at Day 0

    hand grip

  23. hand grip

    Time frame: at Day 30

    hand grip

  24. hand grip

    Time frame: at Day 100

    hand grip

  25. hand grip

    Time frame: at Day 300

    hand grip

Secondary outcomes

  1. Quality of life assessment,

    Time frame: at pre transplant

    it's a satisfaction patient's scale

  2. Quality of life assessment,

    Time frame: at Day 0

    it's a satisfaction patient's scale

  3. Quality of life assessment,

    Time frame: at Day 30

    it's a satisfaction patient's scale

  4. Quality of life assessment,

    Time frame: at Day 100

    it's a satisfaction patient's scale

  5. Quality of life assessment,

    Time frame: at Day 300

    it's a satisfaction patient's scale

  6. number of infections,

    Time frame: at pre transplant

    number of infections,

  7. number of infections,

    Time frame: at Day 0

    number of infections,

  8. number of infections,

    Time frame: at Day 30

    number of infections,

  9. number of infections,

    Time frame: at Day 100

    number of infections,

  10. number of infections,

    Time frame: at Day 300

    number of infections,

  11. number of graft versus host disease,

    Time frame: at pre transplant

    number of graft versus host disease,

  12. number of graft versus host disease,

    Time frame: at Day 0

    number of graft versus host disease,

  13. number of graft versus host disease,

    Time frame: at Day 30

    number of graft versus host disease,

  14. number of graft versus host disease,

    Time frame: at Day 100

    number of graft versus host disease,

  15. number of graft versus host disease,

    Time frame: at Day 300

    number of graft versus host disease,

  16. overall survival

    Time frame: at pre transplant

    overall survival

  17. overall survival

    Time frame: at Day 0

    overall survival

  18. overall survival

    Time frame: at Day 30

    overall survival

  19. overall survival

    Time frame: at Day 100

    overall survival

  20. overall survival

    Time frame: at Day 300

    overall survival

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: NUTRITION

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Feb 4, 2019
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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