Hepatoprotective program for children with acute lymphoblastic leukemia
Hepatoprotective Measures for Children and Adolescents With Acute Lymphoblastic Leukemia During Induction Chemotherapy
PHASE4 · Ain Shams University · NCT06918054
This study tests if changes in diet and omega-3 supplements can help protect the livers of children with acute lymphoblastic leukemia during their chemotherapy treatment.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 2 Years to 18 Years |
| Sex | All |
| Sponsor | Ain Shams University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Cairo and 1 other locations) |
| Trial ID | NCT06918054 on ClinicalTrials.gov |
What this trial studies
This study aims to monitor and prevent acute liver injury in children and adolescents undergoing induction chemotherapy for acute lymphoblastic leukemia (ALL). It will evaluate liver function through tests conducted before, during, and after chemotherapy to assess the impact of dietary modifications and omega-3 fatty acid supplementation. The goal is to minimize hepatotoxicity and ensure the effective delivery of chemotherapy without interruptions due to liver complications.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 2 to 18 years who are newly diagnosed with acute lymphoblastic leukemia and are starting induction chemotherapy.
Not a fit: Patients with known chronic liver disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce liver toxicity in young patients, allowing for more effective chemotherapy treatment.
How similar studies have performed: While there have been studies focusing on hepatotoxicity in chemotherapy, this specific approach combining dietary modifications and supplementation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cairo and 1 other locations
- Ain Shams University — Cairo, Egypt (RECRUITING)
- Faculty of Medicine Ain Shams Research Institute- Clinical Research Center (MASRI-CRC) — Cairo, Egypt (RECRUITING)
Study contacts
- Study coordinator: Fatma S E Ebeid, MD
- Email: fatmaebeid@med.asu.edu.eg
- Phone: 01095569596
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Leukaemia, Acute Lymphoblastic Leukemia, Hepatoprotective program