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NCT Number: NCT06918054

Hepatoprotective for Children and Adolescent With Acute Lymphoblastic Leukemia

This current study will implement a proposed whole program of monitoring and prevention acute hepatic injury during the time of induction chemotherapy in children and adolescent with ALL.

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Key information

Conditions

Leukaemia (Acute) Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University, Cairo, Egypt

Loading trial locations.

About this study

Children and adolescent with acute lymphoblastic leukemia (ALL) can exhibit a wide spectrum of hepatotoxicity ranging from asymptomatic to clinically significant during induction chemotherapy. Unmonitored hepatic status can lead to a hepatic toxicity that might result in unwarranted interruption of the aimed delivery of dose dense chemotherapy to induce remission and consequent treatment.

To evaluate the effect of chemotherapy in children and adolescent with ALL during induction phase, through recording liver function tests before, during and after induction chemotherapy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children and adolescents aged from 2 to 18 years newly diagnosed with acute lymphoblastic leukemia during induction phase of chemotherapy treated at Ain Shams

Exclusion criteria

Known chronic liver disease.

Treatment and study plan

Dietary modification

Dietary Supplement

Patients will follow Mediterranean Diet (MD), this diet is characterized by a high intake of vegetables, fruit, whole cereals, legumes, nuts, and fish and a low intake of red meat and homemade desserts. The main added fat was extra virgin olive oil, with 35-40% kcal from fat (<10% from saturated fat), 40-44% kcal from carbohydrate, and 20% kcal from protein

Supplementation of omega 3 fatty acids

Dietary Supplement

Supplementation of omega 3 fatty acids ( dose based on weight: <40 kg-450 mg/day, 40-60 kg-900 mg/day, >60 kg-1300 mg/day)

Primary outcomes

  1. Implementation a program of hepatic support

    Time frame: Almost 1 year

    To implement a hepatoprotection interventional program to children and adolescent with ALL during Total XV induction c

Study contacts

Contact information is provided by the study sponsor or research team.

Fatma S E Ebeid, MD

CONTACT

[email protected]

01095569596

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Hepatoprotective Measures for Children and Adolescents With Acute Lymphoblastic Leukemia During Induction Chemotherapy

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 9, 2025
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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