Hepatoprotective for Children and Adolescent With Acute Lymphoblastic Leukemia

Ain Shams University

Status and phase: Enrolling; Phase 4

Conditions: Leukaemia (Acute); Acute Lymphoblastic Leukemia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06918054

FMASU MD278/2023 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 2 to 18 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Retrospective historical control

No Intervention group

Description:

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 group

Description:

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)

Treatment:

Dietary Supplement: Supplementation of omega 3 fatty acids

Dietary Supplement: Dietary modification