Hepatoprotective for Children and Adolescent With Acute Lymphoblastic Leukemia
NCT ID: NCT06918054
Last Updated: 2025-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
42 participants
INTERVENTIONAL
2023-11-17
2025-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Retrospective historical control
Retrospective historical control (Arm 1): Children and adolescent with ALL received Total XV induction chemotherapy from 1st June 2018 till 30th April 2023
No interventions assigned to this group
Interventional arm (Arm 2):Children and adolescent with ALL receiving Total XV induction chemotherap
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 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
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)
Interventions
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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
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)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2 Years
18 Years
ALL
Yes
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Principal Investigators
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Manal El-Sayed, MD
Role: STUDY_CHAIR
Faculty of Medicine Ain Shams University
Locations
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Ain Shams University
Cairo, , Egypt
Faculty of Medicine Ain Shams Research Institute- Clinical Research Center (MASRI-CRC)
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Fatma Azazy
Role: backup
Role: backup
Other Identifiers
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FMASU MD278/2023
Identifier Type: OTHER
Identifier Source: secondary_id
FMASU MD278/2023
Identifier Type: -
Identifier Source: org_study_id
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