Effect of Omega-3 Fatty Acids on Methotrexate Induced Hepatotoxicity in Children With Acute Lymphoblastic Leukemia
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 2

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.
    

Detailed 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.
    

Intervention name(s): Omega-3 Fatty Acids; Methotrexate
Intervention type(s): Drug; Drug
Intervention description(s): 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 .; 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 .
Other intervention name(s): Super-omega®; Rheumatrex
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: omega-3 fatty acids; methotrexate; hepatotoxicity