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

Evaluating the effect of silymarin oral form on the control of liver toxicity caused by AC regimn in patients with non metastatic breast cancer

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017091136125N1

Enrollment

Registered

2017-10-24

Start date

2017-10-23

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Hepatotoxicity. Hepatotoxicity

Interventions

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

Treatment - Drugs

Placebo

Intervention group: Livergol 140 mg three tablets daily after meals (produced by Goldaroo company), oral, for 4weeks

Control group : Placebo tablets for Livergol, three tablet daily after meals, for 4 week, oral

Eligibility

Sex/Gender

Female

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

Measure	Time 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 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.	—

Measure

Time 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 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

Measure	Time 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 begining of the study. Method of measurement: Serum level measurementl by labratory.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactGhazal Saadat Askarpour Moezian

Mashhad University of Medical Science, Faculty of Pharmacy

asgarpourgh921@mums.ac.ir+98 51 3882 3255

Outcome results

None listed

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