Evaluating the effect of silymarin oral form on the control of liver toxicity caused by adriamycin and cyclophosphamide drugs in patients with non metastatic breast cancer
Phase 3
Recruiting
- Conditions
- Hepatotoxicity.Hepatotoxicity
- Registration Number
- IRCT2017091136125N1
- Lead Sponsor
- Vice chancellor for research, Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 40
Inclusion Criteria
Non-metastatic breast cancer that has undergone chemotherapy with cyclophosphamide + doxorubicin after mastectomy; Grade 2 or higher grade liver toxicity based on NCI-CTC version4 based on AST, ALT or Bilirubin level that will be evaluated at the beginning of each chemotherapy course; Age between 18 to 65 years
Exclusion criteria: Patients with viral hepatitis (A, B and C); hepatobiliary obstruction; history of hepatic or renal; malabsorbtion syndrome ; gastrointestinal obstruction ; patients dissatisfaction; co-administration of hepatotoxic medications; consumption of antioxidant medication; chemotherapy regimen modification
Exclusion Criteria
Not provided
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 afterthe beginning of study, one month after the begining of the study. Method of measurement: Serum level measurement by labratory.;Liver ultrasound to determine the stage of the fatty liver. Timepoint: at the beginning of the study, one month after the begining of the study. Method of measurement: Ultrasound.;Hepatic fibroscan. Timepoint: One month after the begining of the study. Method of measurement: Fibroscan.
- 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 begining of the study. Method of measurement: Serum level measurementl by labratory.