Evaluation of silymarin tablet efficacy in prevention of hepatotoxicity induced by doxorubicin containing chemotherapy regimen in patients with non-metastatic breast cancer
Phase 3
Recruiting
- Conditions
- K71.1hepatotoxicity.Toxic liver disease with hepatic necrosis, with coma
- Registration Number
- IRCT20200408046990N6
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 50
Inclusion Criteria
Age between 18-65 y
Patients with diagnosis of non-metastatic breast cancer who will be treated by doxurobicin after mastectomy
Signing the written consent
Exclusion Criteria
Viral hepatitis
History of hypersensitivity to silymarin or similar compounds
Pregnancy and lactation
Liver involvement grade 2 or higher based on ultrasound evaluation
Any kind of liver injury resulting in rise of liver enzymes or bilirubin to higher than upper limit normal
Hepatobiliary obstruction
Renal failure (GFR<30 mL/min)
Malabsorption syndrome
Concomitant use of heptotoxic agents or antioxidants
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum level of hepatic transaminases, total billirubin, direct billirubin, prothrombin time, serum albumin, alkalin phosphatase. Timepoint: At the beginning of the study, 2 weeks after the beginning of study, one month after the beginning of the study. Method of measurement: Serum level measurement by the laboratory.;Liver ultrasound to determine the stage of the fatty liver. Timepoint: At the beginning of the study, one month after the beginning of the study. Method of measurement: Ultrasound evaluation.
- Secondary Outcome Measures
Name Time Method Serum level of creatinine and urea. Timepoint: At the beginning of the study, 2 weeks after the beginning of study, one month after the beginning of the study. Method of measurement: Serum level measurement by the laboratory.