Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202208655573502 Date of Approval: 22/08/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of alpha lipoic acid on methotrexate-induced hepatotoxicity in children with acute lymphoblastic leukemia
Official scientific title Effect of alpha lipoic acid on methotrexate-induced hepatotoxicity in children with acute lymphoblastic leukemia
Brief summary describing the background and objectives of the trial Methotrexate (MTX) an antimetabolite drug, is an effective chemotherapeutic agent that have been widely used in the treatment of pediatric malignancies including acute lymphocytic leukemia.MTX-associated hepatotoxicity is a significant clinical problem that affects patient compliance with MTX-containing treatment regimens as well as discontinuation of therapy. It prolongs the duration of hospitals stays and may affect the overall prognosis and outcome of the disease. Oxidative stress plays a key role in the pathogenesis of MTX-induced hepatotoxicity. The increased generation of reactive oxygen and nitrogen species, together with the decreased antioxidant defense, promotes the development and progression of hepatotoxicity. Alpha-lipoic acid (ALA) is an antioxidant that has many properties including the decrease of reactive oxygen species, regeneration of endogenous antioxidants such as vitamin C and glutathione, prevention of lipid and protein peroxidation and decreasing oxidative stress. The aim of this study is determine the possible protective effect of alpha lipoic acid on MTX induced liver toxicity in acute lymphoblastic leukemia children
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 30/06/2022
Actual trial start date
Anticipated date of last follow up 31/12/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Alpha lipoic a group 300 mg twice daily 6 months 30 newly diagnosed acute lymphocytic leukemia patients will receive chemotherapy including MTX and alpha lipoic acid. Detailed medical history will be collected and blood samples will be obtained for routine investigation of acute lymphoblastic leukemia and for measurement of malondialdhyde, glutathione, superoxide dismutase and the liver function tests including ALT, AST, alkaline phosphatase (ALP), and g-glutamyl transpeptidase (GGP). 40
Control Group placebo group twice daily 6 months 30 newly diagnosed acute lymphocytic leukemia patients will receive chemotherapy including MTX and placebo. Detailed medical history will be collected and blood samples will be obtained for routine investigation of acute lymphoblastic leukemia and for measurement of malondialdhyde, glutathione, superoxide dismutase and the liver function tests including ALT, AST, alkaline phosphatase (ALP), and g-glutamyl transpeptidase (GGP). 40 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children of newly diagnosed acute lymphoblastic leukemia patients with history of liver disease or active hepatitis (serum transaminases more than three times the upper limit of normal), potential exposure to agents capable of damaging the liver (such as heavy metals or solvents), regular consumption of drugs other than MTX with potential hepatotoxicity, renal impairment (serum creatinine more than twice the upper limit of normal), sepsis or active infection, relapse or secondary malignancy, serious complications that may necessitate cessation of chemotherapy for undetermined duration will be excluded in our study. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 6 Year(s) 18 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/02/2022 local ethical committee of faculty of medicine of tanta uinversity
Ethics Committee Address
Street address City Postal code Country
Elgeish street Tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the liver function tests including ALT, AST, alkaline phosphatase (ALP), and g-glutamyl transpeptidase (GGP). after end of the treatment which is 6 months
Secondary Outcome levels of oxidative stress such as malondialdhyde, glutathione, and superoxide dismutase after end of the treatment which is 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital Elgeish street Tanta 31511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Doaa El Amrousy Motasem street Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor aculty of medicine of tanta university Elgeish street Tanta Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dalia ElAfify Nile street Kafr Elsheikh Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dalia El Afifi daliaelafify@yahoo.com 00201006831039 Nile street
City Postal code Country Position/Affiliation
Kafr Elsheikh Egypt lecturer of clinical pharmacy
Role Name Email Phone Street address
Public Enquiries Mohamed Elkashlan mohamedkashlan@yahoo.com 00201222337746 Elmoatsem street
City Postal code Country Position/Affiliation
Tanta Egypt consultant of anesthesiology
Role Name Email Phone Street address
Scientific Enquiries Doaa El Amrousy doaamoha@yahoo.com 00201278155283 Elmotasem street
City Postal code Country Position/Affiliation
Tanta Egypt Profressor of pediatrics
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes summary results will be shared in a word document format Statistical Analysis Plan,Study Protocol within 12 months of the end of the study controlled access after approval of the authors
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information