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

Leukemia, Lymphoblastic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06110182
• Other study ID #: 2023_PI_069
• Status: Active, not recruiting
• Start date: October 1, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: October 2023
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: May 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoblastic
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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

Locations

Country	Name	City	State
France	CHRU Nancy	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Z-score	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	BMI	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
Secondary	albumin	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
Secondary	complications	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