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

October 26, 2023 updated by: DEUTSCH Hélène, Central Hospital, Nancy, France

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandœuvre-lès-Nancy, France, 54500
        • CHRU Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

children diagnosed with acute lymphoblastic leukemia between 2010 and 2021 in Nancy and Reims

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Z-score
Time Frame: 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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI
Time Frame: 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
6 months
albumin
Time Frame: 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
6 months
complications
Time Frame: 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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

October 26, 2023

First Submitted That Met QC Criteria

October 26, 2023

First Posted (Actual)

October 31, 2023

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 26, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023_PI_069

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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