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

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06110182
Collaborator
(none)
300
1
19
15.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: enteral or parenteral nutritional support

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Evaluation of the Advantage in the Use of Enteral Nutrition in Children Treated for Acute Lymphoblastic Leukemia
Actual Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2025
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

Arm Intervention/Treatment
enteral nutrition

children who received enteral nutritional support during treatment

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

parenteral nutrition

children who received parenteral nutritional support during treatment

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

Outcome Measures

Primary Outcome Measures

  1. Z-score [6 months]

    Compare 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 Outcome Measures

  1. BMI [6 months]

    Compare 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

  2. albumin [6 months]

    Compare 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

  3. complications [1 year]

    Compare 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 18 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHRU Nancy Vandœuvre-lès-Nancy France 54500

Sponsors and Collaborators

  • Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
DEUTSCH Hélène, Dr Hélène DEUTSCH, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT06110182
Other Study ID Numbers:
  • 2023_PI_069
First Posted:
Oct 31, 2023
Last Update Posted:
Oct 31, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 31, 2023