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

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Brief Title

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

Official Title

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

Brief 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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Number of Participants with Adverse Events as a Measure of Safety and Tolerability by measuring Malondialdehyde (MDA) level changes .

Secondary Outcome

 Number of Participants with Adverse Events as a Measure of Safety and Tolerability by measuring ALT value changes.

Condition

Acute Lymphoblastic Leukemia

Intervention

Omega-3 Fatty Acids

Study Arms / Comparison Groups

 Intervention arm with Omega 3 FA
Description:  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 .

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

70

Start Date

June 2012

Completion Date

October 2014

Primary Completion Date

October 2014

Eligibility Criteria

        Inclusion Criteria:

          -  Child age: less than 17 years old.

          -  Taking oral methotrexate in maintenance therapy.

          -  Patients are at cycle one day zero.

        Exclusion Criteria:

          -  Child infected by hepatitis B or C viruses.

          -  Child taking medications or having a condition causing elevation in liver enzymes
             level other than methotrexate.(eg:thrombosis ,antibiotic therapy, infiltrating
             malignancy ,auto immune manifestations or having TPN)

          -  Child remission.

          -  Child death

          -  Child drop out due to non compliance
      

Gender

All

Ages

2 Years - 16 Years

Accepts Healthy Volunteers

No

Contacts

, , 



Administrative Informations


NCT ID

NCT02373579

Organization ID

Ain Shams University 1351


Responsible Party

Sponsor-Investigator

Study Sponsor

Nancy Samir Elbarbary


Study Sponsor

, , 


Verification Date

February 2015