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Trial Title:
Evaluation of the Advantage in the Use of Enteral Nutrition in Children Treated for Acute Lymphoblastic Leukemia
NCT ID:
NCT06110182
Condition:
Leukemia, Lymphoblastic
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
enteral or parenteral nutritional support
Description:
Parents will be classified based on whether they received enteral or parenteral
nutritional support during treatment.
Arm group label:
enteral nutrition
Arm group label:
parenteral nutrition
Summary:
This is a multicenter retrospective study (Reims and Nancy), with data collection over 12
years from 01/01/2010 to 12/31/2022 Patients included are children diagnosed with acute
lymphoblastic leukemia between 2010 and 2021 in the 2 centers.
Patients will be categorized into 3 groups:
- No nutritional support
- Support by enteral nutrition
- Parenteral nutrition support Their nutritional status will be assessed at the end of
induction, at 6 months and then at 12 months from diagnosis.
The main objective of this study is therefore to compare the nutritional status of
children with acute lymphoblastic leukemia depending on whether they received enteral or
parenteral nutritional support during their treatment.
The secondary objective is to evaluate the occurrence of complications during treatment
according to the nutritional support received.
Criteria for eligibility:
Study pop:
children diagnosed with acute lymphoblastic leukemia between 2010 and 2021 in Nancy and
Reims
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Children between 1 and 18 years old diagnosed with Medium risk/ High Risk B acute
lymphoblastic leukemia or Standard/ High Risk T acute lymphoblastic leukemia between
2010 and 2021 in Nancy and Reims.
Exclusion Criteria:
- Patients less than 1 year old
- leukémia with philadelphia chromosome
- standard risk B acute lymphoblastic leukemia
- bone marrow transplant during treatment
- death during the year following diagnosis
- refusal of the patient (parents) to participate in the study
Gender:
All
Minimum age:
1 Year
Maximum age:
18 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
CHRU Nancy
Address:
City:
Vandœuvre-lès-Nancy
Zip:
54500
Country:
France
Start date:
October 1, 2023
Completion date:
May 1, 2025
Lead sponsor:
Agency:
Central Hospital, Nancy, France
Agency class:
Other
Source:
Central Hospital, Nancy, France
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06110182
