Leukaemia (Acute)Phase 4NCT06918054
Hepatoprotective for Children and Adolescent With Acute Lymphoblastic Leukemia
A Phase 4 study testing Dietary modification and Supplementation of omega 3 fatty acids in people with Leukaemia (Acute) and Acute Lymphoblastic Leukemia, run by Ain Shams University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Leukaemia (Acute), Acute Lymphoblastic Leukemia
- What is being tested?
- Dietary modification and Supplementation of omega 3 fatty acids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesEgypt
- Study dates
- 17 Nov 2023to Aug 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children and adolescents aged from 2 to 18 years newly diagnosed with acute lymphoblastic leukemia during induction phase of chemotherapy treated at Ain Shams
Who cannot join
- Known chronic liver disease.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
Ain Shams University
Cairo, 11566
Fatma SE Ebeid, MD, 01095569596, fatmaebeid@med.asu.edu.eg
Fatma Azazy
- Recruiting
Faculty of Medicine Ain Shams Research Institute- Clinical Research Center (MASRI-CRC)
Cairo, 11566
Fatma Ebeid, 01095569596, fatmaebeid@med.asu.edu.eg
dr.fatma_ebeid@yahoo.com
About this study
Official title: Hepatoprotective Measures for Children and Adolescents With Acute Lymphoblastic Leukemia During Induction Chemotherapy
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.
Read the 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
- Being tested
- Dietary modification, Supplementation of omega 3 fatty acids
- Keywords
- Acute Lymphoblastic Leukemia, Hepatoprotective program
- Medical subject headings
- Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary modificationDietary 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
Supplementation of omega 3 fatty acidsDietary 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)
| Study group | Role | What they receive |
|---|---|---|
| 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
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) Receives: Dietary Supplement: Dietary modification; Dietary Supplement: Supplementation of omega 3 fatty acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation a program of hepatic support
To implement a hepatoprotection interventional program to children and adolescent with ALL during Total XV induction c
Measured: Almost 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start17 Nov 2023
- Primary completionMay 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukaemia (Acute)Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manal El-Sayed, MD, Study chair, Faculty of Medicine Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918054
- Sponsor's protocol ID
- FMASU MD278/2023
- Other IDs
- FMASU MD278/2023
- Status last verified
- Apr 2025
- First submitted
- 6 Dec 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatoprotective Measures for Children and Adolescents With Acute Lymphoblastic Leukemia During Induction Chemotherapy
- ClinicalTrials.gov ID
- NCT06918054
- Acronym / sponsor ID
- FMASU MD278/2023
- Conditions
- Leukaemia (Acute), Acute Lymphoblastic Leukemia
- Keywords
- Acute Lymphoblastic Leukemia, Hepatoprotective program
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Dietary Supplement: Dietary modification, Dietary Supplement: Supplementation of omega 3 fatty acidsImplementation 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) |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children and adolescents aged from 2 to 18 years newly diagnosed with acute lymphoblastic leukemia during induction phase of chemotherapy treated at Ain Shams
Key exclusion criteria (1 listed)
- Known chronic liver disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary modificationPatients 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 | Interventional arm (Arm 2):Children and adolescent with ALL receiving Total XV induction chemotherap |
| Supplementation of omega 3 fatty acidsSupplementation 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 supplement | Interventional arm (Arm 2):Children and adolescent with ALL receiving Total XV induction chemotherap |
Primary outcome
Implementation a program of hepatic support
Time frame: Almost 1 year
To implement a hepatoprotection interventional program to children and adolescent with ALL during Total XV induction c
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manal El-Sayed, MD study chair
Faculty of Medicine Ain Shams University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dietary modification and Supplementation of omega 3 fatty acids in people with Leukaemia (Acute) and Acute Lymphoblastic Leukemia, run by Ain Shams University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma S E Ebeid, MD (01095569596, fatmaebeid@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation a program of hepatic support (time frame: Almost 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.