Protecting the heart during chemotherapy for children with leukemia
The Effect of Cardioprotective Medications on Chemotherapy-Induced Cardiotoxicity in Childhood Acute Leukemia
PHASE3 · Ain Shams University · NCT06853951
This study tests whether certain heart medications can help protect children with leukemia from heart damage caused by chemotherapy.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | Ain Shams University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Cairo and 1 other locations) |
| Trial ID | NCT06853951 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to assess the effectiveness of cardioprotective medications, specifically ACE inhibitors and β-blockers, in reducing chemotherapy-induced cardiotoxicity in pediatric patients diagnosed with acute leukemia. The study will measure the impact of these medications on the left ventricular ejection fraction (LVEF) using 2D echocardiography at the beginning and end of the 42-day induction phase of chemotherapy. By comparing the cardiotoxicity profiles of the two medication groups, the study seeks to identify the most effective cardioprotective strategy for young patients undergoing chemotherapy.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients aged 2-18 years who are diagnosed with acute leukemia and can take oral medication.
Not a fit: Patients with documented allergies to the cardioprotective medications being tested will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of heart damage in children receiving chemotherapy for leukemia.
How similar studies have performed: Other studies have shown promise in using cardioprotective medications in similar contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Willingness of the legal representative of research participant to participate in the study by giving "informed consent." * Ability to take oral medication. * Age 2-18 years at the time of diagnosis. Exclusion Criteria: * Documented allergy to cardioprotective medications
Where this trial is running
Cairo and 1 other locations
- Faculty of Pharmacy, Ain Shams University — Cairo, Egypt (RECRUITING)
- Faculty of Pharmacy, Ain Shams University — Cairo, Egypt (RECRUITING)
Study contacts
- Principal investigator: Manal Hamed El-Hamamsy, Prof — Ain Shams University
- Study coordinator: Christen Said
- Email: keristin.nazir21@pharma.asu.edu.eg
- Phone: +201093942389
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: Cardiotoxicity