Skip to content

Evaluation of the Advantage in the Use of Enteral Nutrition in Children Treated for Acute Lymphoblastic Leukemia

Evaluation of the Advantage in the Use of Enteral Nutrition in Children Treated for Acute Lymphoblastic Leukemia

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06110182
Enrollment
300
Registered
2023-10-31
Start date
2023-10-01
Completion date
2025-05-01
Last updated
2023-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Lymphoblastic

Brief 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.

Interventions

DIETARY_SUPPLEMENTenteral or parenteral nutritional support

Parents will be classified based on whether they received enteral or parenteral nutritional support during treatment.

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Z-score6 monthsCompare the improvement in Z-score between the date of diagnosis and 6 months from diagnosis in children using parenteral nutrition and those using enteral nutrition during treatment of their acute lymphoblastic leukemia

Secondary

MeasureTime frameDescription
BMI6 monthsCompare the improvement in BMI between the date of diagnosis and 6 months from diagnosis in children using parenteral nutrition and those using enteral nutrition during treatment of their acute lymphoblastic leukemia
albumin6 monthsCompare the improvement in albumin level between the date of diagnosis and 6 months from diagnosis in children using parenteral nutrition and those using enteral nutrition during treatment of their acute lymphoblastic leukemia
complications1 yearCompare the percentages of occurrence of complications between the date of diagnosis and 6 months after diagnosis in children using parenteral nutrition and those using enteral nutrition during treatment for their acute lymphoblastic leukemia

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026