Effect of Omega-3 Fatty Acids on Methotrexate Induced Hepatotoxicity in Children With Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia Clinical Trial

Official title: Effect of Omega-3 Fatty Acids on Methotrexate Induced Hepatotoxicity in Children With Acute Lymphoblastic Leukemia

Status Completed

Clinical Trial Summary

Study the role of oxidative stress in methotrexate induced hepatic damage, and the possible protective effect of OMEGA-3 fatty acids against methotrexate hepatotoxicity using clinical and biochemical parameters.

Clinical Trial Description

The patients were divided into two groups :Group I: control group, included pediatric patients with standard risk acute lymphoblastic leukemia in maintenance phase day 0 and receiving oral Methotrexate (20 mg / m2) weekly without any supplementation .

Group II: study group, included standard risk ALL pediatric patients who were supplemented with oral omega-3 capsule (one capsule / day) .

Omega-3 was supplied as soft gelatin capsules in a dose of 1000 mg of omega-3 fatty acids/day . This is in addition to chemotherapy from day one of maintenance phase receiving oral Methotrexate (20 mg / m2) Weight -adjusted doses on days 8, 15, 22, 29,36,43,50,57,64,71and 78).

Both groups were followed up for six months . All patients were under free diet and were maintained on standard diet throughout the study ( 6 months). None of them were on regular vitamin supplementation before diagnosis or at time of chemotherapy administration.

Patients follow up:

The patients were followed up every three week for the whole study period for assessing the effect and compliance to both MTX and Omega-3 fatty acid and for monitoring any potential adverse effect.

Group I were asked on each visit about signs of hepatic toxicity ( fatigue , weakness , loss of appetite , vague abdominal pain , color of urine and sclera and jaundice ), their laboratory results were revised to know level of ALT as a marker of liver injury .

Group II were asked on each visit about signs of hepatotoxicity , their laboratory data were revised , any side effects resulted from use Omega-3 fatty acids:

(increased bleeding tendency, fishy smell , nausea , diarrhea , or if there is any relapses occurred , and to be sure that the patients were compliant to prescribed medication.

Investigations:

Blood samples were collected from every patient at day 0 of maintenance and after six months for estimation of Malondialdehyde (MDA), Total antioxidant capacity (TAC), super oxide dismutase ,liver function tests and uric acids . Blood was collected into heparinised tubes which were protected from light and processed immediately after sampling. At the time of collecting the blood samples, patients were free of any potentially confounding or interfering conditions, such as infections or fever. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

• NCT number: NCT02373579
• Study type: Interventional
• Source: Ain Shams University
• Status: Completed
• Phase: Phase 2
• Start date: June 2012
• Completion date: October 2014