Hepatoprotective for Children and Adolescent With Acute Lymphoblastic Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dietary modification, Supplementation of omega 3 fatty acids.
- Who it may be relevant to
- Registry conditions: Leukaemia (Acute), Acute Lymphoblastic Leukemia. Basic parameters: 2 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Hepatoprotective Measures for Children and Adolescents With Acute Lymphoblastic Leukemia During Induction Chemotherapy
Overview
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.
Interventions
- 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)
Primary outcome measures
- Implementation a program of hepatic support [Time frame: Almost 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Egypt · 2 centers
- Ain Shams University — Cairo
- Faculty of Medicine Ain Shams Research Institute- Clinical Research Center (MASRI-CRC) — Cairo
Identifiers
NCT: NCT06918054 · FMASU MD278/2023 · FMASU MD278/2023