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Evaluation of silymarin tablet efficacy in prevention of hepatotoxicity induced by doxorubicin containing chemotherapy regimen in patients with non-metastatic breast cancer

Evaluation of oral silymarin formulation efficacy in prevention of hepatotoxicity induced by doxorubicin containing chemotherapy regimen in patients with non-metastatic breast cancer

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200408046990N6
Enrollment
50
Registered
2021-01-13
Start date
2021-01-20
Completion date
Unknown
Last updated
2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatotoxicity. Toxic liver disease with hepatic necrosis, with coma

Interventions

Intervention 1: Intervention group: Livergol 140 mg three tablets daily after meals (produced by Goldaroo company), oral, for 4 weeks. Intervention 2: Control group: Placebo tablets for Livergol, thre

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSepideh Elyasi

Mashhad University of Medical Sciences

elyasis@mums.ac.ir+98 51 3180 1588

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026