NCT06918054

Hepatoprotective for Children and Adolescent With Acute Lymphoblastic Leukemia

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Leukaemia (Acute)
• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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
DIETARY_SUPPLEMENT	Supplementation of omega 3 fatty acids	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)

Timeline

• Start date: 2023-11-17
• Primary completion: 2025-05-01
• Completion: 2025-08-01
• First posted: 2025-04-09
• Last updated: 2025-04-09

Locations

2 sites across 1 country: Egypt