AllograftNUTRITIONNCT03829072
Cooking Education and Adapted Physical Activity in Allografted Patients
A study testing Cooking Education and adapted physical activity in people with Allograft, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allograft
- What is being tested?
- Cooking Education and adapted physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 21 Mar 2019to 12 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Cooking Education, adapted physical activity
- Keywords
- Allo Stem Cell Transplantation, Cooking, Physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooking EducationOther
cooking Education and adapted physical activity on patients after allo stem cell transplantation
adapted physical activityOther
cooking Education and adapted physical activity on patients after allo stem cell transplantation
| Study group | Role | What they receive |
|---|---|---|
| cooking Education and adapted physical activity | Experimental | Not described Receives: Other: Cooking Education; Other: adapted physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
Body mass index
Measured: at pre transplant
Body mass index
Body mass index
Measured: at Day 0
Body mass index
Body mass index
Measured: at Day 30
Body mass index
Body mass index
Measured: at Day 100
Body mass index
Body mass index
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: at Day 300
sit up test
sit up test
Measured: at pre transplant
sit up test
sit up test
Measured: at Day 0
sit up test
sit up test
Measured: at Day 30
sit up test
sit up test
Measured: at Day 100
sit up test
sit up test
Measured: at Day 300
bio electrical impedance analysis,
it's measuring the resistance of biological tissues
Measured: at pre transplant
bio electrical impedance analysis,
it's measuring the resistance of biological tissues
Measured: at Day 0
bio electrical impedance analysis,
it's measuring the resistance of biological tissues
Measured: at Day 30
bio electrical impedance analysis,
it's measuring the resistance of biological tissues
Measured: at Day 100
bio electrical impedance analysis,
it's measuring the resistance of biological tissues
Measured: at Day 300
hand grip
hand grip
Measured: at pre transplant
hand grip
hand grip
Measured: at Day 0
hand grip
hand grip
Measured: at Day 30
hand grip
hand grip
Measured: at Day 100
hand grip
hand grip
Measured: at Day 300
Secondary outcomes (20)
Quality of life assessment,
it's a satisfaction patient's scale
Measured: at pre transplant
Quality of life assessment,
it's a satisfaction patient's scale
Measured: at Day 0
Quality of life assessment,
it's a satisfaction patient's scale
Measured: at Day 30
Quality of life assessment,
it's a satisfaction patient's scale
Measured: at Day 100
Quality of life assessment,
it's a satisfaction patient's scale
Measured: at Day 300
number of infections,
number of infections,
Measured: at pre transplant
number of infections,
number of infections,
Measured: at Day 0
number of infections,
number of infections,
Measured: at Day 30
number of infections,
number of infections,
Measured: at Day 100
number of infections,
number of infections,
Measured: at Day 300
number of graft versus host disease,
number of graft versus host disease,
Measured: at pre transplant
number of graft versus host disease,
number of graft versus host disease,
Measured: at Day 0
number of graft versus host disease,
number of graft versus host disease,
Measured: at Day 30
number of graft versus host disease,
number of graft versus host disease,
Measured: at Day 100
number of graft versus host disease,
number of graft versus host disease,
Measured: at Day 300
overall survival
overall survival
Measured: at pre transplant
overall survival
overall survival
Measured: at Day 0
overall survival
overall survival
Measured: at Day 30
overall survival
overall survival
Measured: at Day 100
overall survival
overall survival
Measured: at Day 300
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start21 Mar 2019
- Primary completion9 May 2022
- Study completion12 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllograftStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas CLUZEAU, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03829072
- Sponsor's protocol ID
- 18-PP-10
- Acronym
- NUTRITION
- Status last verified
- Feb 2024
- First submitted
- 27 Dec 2018
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03829072
- Acronym / sponsor ID
- NUTRITION / 18-PP-10
- Conditions
- Allograft
- Keywords
- Allo Stem Cell Transplantation, Cooking, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 9 May 2022 (actual)
- Study completion
- 12 Feb 2023 (actual)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cooking Education and adapted physical activity | Experimental | Other: Cooking Education, Other: adapted physical activity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cooking Educationcooking Education and adapted physical activity on patients after allo stem cell transplantation | Other | cooking Education and adapted physical activity |
| adapted physical activitycooking Education and adapted physical activity on patients after allo stem cell transplantation | Other | cooking Education and adapted physical activity |
Primary outcome
Body mass index
Time frame: at pre transplant
Body mass index
Body mass index
Time frame: at Day 0
Body mass index
Body mass index
Time frame: at Day 30
Body mass index
Body mass index
Time frame: at Day 100
Body mass index
Body mass index
Time frame: at Day 300
Body mass index
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.
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
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
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
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
sit up test
Time frame: at pre transplant
sit up test
sit up test
Time frame: at Day 0
sit up test
sit up test
Time frame: at Day 30
sit up test
sit up test
Time frame: at Day 100
sit up test
sit up test
Time frame: at Day 300
sit up test
bio electrical impedance analysis,
Time frame: at pre transplant
it's measuring the resistance of biological tissues
bio electrical impedance analysis,
Time frame: at Day 0
it's measuring the resistance of biological tissues
bio electrical impedance analysis,
Time frame: at Day 30
it's measuring the resistance of biological tissues
bio electrical impedance analysis,
Time frame: at Day 100
it's measuring the resistance of biological tissues
bio electrical impedance analysis,
Time frame: at Day 300
it's measuring the resistance of biological tissues
hand grip
Time frame: at pre transplant
hand grip
hand grip
Time frame: at Day 0
hand grip
hand grip
Time frame: at Day 30
hand grip
hand grip
Time frame: at Day 100
hand grip
hand grip
Time frame: at Day 300
hand grip
20 secondary outcomes
Quality of life assessment,
Time frame: at pre transplant
Quality of life assessment,
Time frame: at Day 0
Quality of life assessment,
Time frame: at Day 30
Quality of life assessment,
Time frame: at Day 100
Quality of life assessment,
Time frame: at Day 300
number of infections,
Time frame: at pre transplant
number of infections,
Time frame: at Day 0
number of infections,
Time frame: at Day 30
number of infections,
Time frame: at Day 100
number of infections,
Time frame: at Day 300
number of graft versus host disease,
Time frame: at pre transplant
number of graft versus host disease,
Time frame: at Day 0
number of graft versus host disease,
Time frame: at Day 30
number of graft versus host disease,
Time frame: at Day 100
number of graft versus host disease,
Time frame: at Day 300
overall survival
Time frame: at pre transplant
overall survival
Time frame: at Day 0
overall survival
Time frame: at Day 30
overall survival
Time frame: at Day 100
overall survival
Time frame: at Day 300
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas CLUZEAU principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooking Education and adapted physical activity in people with Allograft, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (time frame: at pre transplant). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.