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| ID | Type | Description | Link |
|---|---|---|---|
| FMASU MD278/2023 | Other Identifier | Faculty of Medicine Ain Shams University Research Ethical Committee |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fatma S E Ebeid, MD | Contact | 01095569596 | fatmaebeid@med.asu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Manal El-Sayed, MD | Faculty of Medicine Ain Shams University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Recruiting | Cairo | 11566 | Egypt |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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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.
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| 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) |
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| Faculty of Medicine Ain Shams Research Institute- Clinical Research Center (MASRI-CRC) | Recruiting | Cairo | 11566 | Egypt |
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| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |