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

NCT ID: NCT06110182

Last Updated: 2023-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Leukemia, Lymphoblastic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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enteral nutrition

children who received enteral nutritional support during treatment

enteral or parenteral nutritional support

Intervention Type DIETARY_SUPPLEMENT

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

enteral or parenteral nutritional support

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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enteral or parenteral nutritional support

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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DEUTSCH Hélène

Dr Hélène DEUTSCH

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CHRU Nancy

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

Other Identifiers

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2023_PI_069

Identifier Type: -

Identifier Source: org_study_id