Hepatoprotective for Children and Adolescent With Acute Lymphoblastic Leukemia

NCT06918054 | Recruiting Phase 4 DMC

• 1 other identifier: FMASU MD278/2023
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Leukaemia (Acute); Acute Lymphoblastic Leukemia

Keywords

Acute Lymphoblastic Leukemia; Hepatoprotective program

Outcome Measures

Primary Outcomes (1)

• Implementation a program of hepatic support

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

  Almost 1 year

Study Arms (2)

Retrospective historical control

NO INTERVENTION

Retrospective historical control (Arm 1): Children and adolescent with ALL received Total XV induction chemotherapy from 1st June 2018 till 30th April 2023

Interventional arm (Arm 2):Children and adolescent with ALL receiving Total XV induction chemotherap

ACTIVE COMPARATOR

Implementation of hepatic supportive program 1. Dietary modification: 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 2. Evaluation of the risk of malnutrition in hospitalized children with cancer through SCAN score which is simple, quick and valid tool. A score of 0 - 1indicates a low risk of malnutrition. A score of 2 indicates a moderate risk of malnutrition. A score of 3 - 5 indicates a high risk of malnutrition. 3. 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)

Dietary Supplement: Dietary modification; Dietary Supplement: Supplementation of omega 3 fatty acids

Interventions

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

Interventional arm (Arm 2):Children and adolescent with ALL receiving Total XV induction chemotherap

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)

Interventional arm (Arm 2):Children and adolescent with ALL receiving Total XV induction chemotherap

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Known chronic liver disease.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (2)

Ain Shams University

Cairo, 11566, Egypt

RECRUITING

Faculty of Medicine Ain Shams Research Institute- Clinical Research Center (MASRI-CRC)

Cairo, 11566, Egypt

RECRUITING

MeSH Terms

Conditions

Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Manal El-Sayed, MD

  Faculty of Medicine Ain Shams University

  STUDY CHAIR

Central Study Contacts

Fatma S E Ebeid, MD

CONTACT

01095569596; fatmaebeid@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Implementation of a proposed whole program of monitoring and prevention of acute hepatic injury during the time of induction chemotherapy in children and adolescent with ALL.

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: April 9, 2025
• Study Start: November 17, 2023
• Primary Completion: May 1, 2025
• Study Completion: August 1, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

EG (2)