Evaluation of oral nano-silymarin formulation effect in prevention of liver damage induced by doxorubicin-cyclophosphamide chemotherapy regimen in patients with non-metastatic breast cancer

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200408046990N13

Enrollment

Registered

2023-09-04

Start date

2023-09-23

Completion date

Unknown

Last updated

2023-10-16

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

Conditions

Non-metastatic breast cancer. Malignant neoplasm of breast

Interventions

Intervention 1: Intervention group: sinalive 70mg twice daily after breakfast and dinner , oral, for 8 weeks. Intervention 2: Control group: Placebo capsule for sinalive, two tablet daily after breakf

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 Any kind of liver injury resulting in rise of liver enzymes or bilirubin to higher than upper limit normal Renal failure Concomitant use of heptotoxic agents or antioxidants

Design outcomes

Primary

Measure	Time frame
Serum level of hepatic transaminases. Timepoint: At the beginning of the study, 4 weeks after the beginning of study, at the end of 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 and at the end of study. Method of measurement: Ultrasound evaluation.;Serum level of total and direct billirubin. Timepoint: At the beginning of the study, 4 weeks after the beginning of study, at the end of study. Method of measurement: Serum level measurement by the laboratory.;Prothrombin time. Timepoint: At the beginning of the study, 4 weeks after the beginning of study, at the end of study. Method of measurement: Serum level measurement by the laboratory.;Serum albumin level. Timepoint: At the beginning of the study, 4 weeks after the beginning of study, at the end of study. Method of measurement: Serum level measurement by the laboratory.;Serum level of alkalin phosphatase. Timepoint: At the beginning of the study, 4 weeks after the beginning of study, at the end of study. Method of measurement: Serum level measurement by the laboratory.	—

Measure

Time frame

Serum level of hepatic transaminases. Timepoint: At the beginning of the study, 4 weeks after the beginning of study, at the end of 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 and at the end of study. Method of measurement: Ultrasound evaluation.;Serum level of total and direct billirubin. Timepoint: At the beginning of the study, 4 weeks after the beginning of study, at the end of study. Method of measurement: Serum level measurement by the laboratory.;Prothrombin time. Timepoint: At the beginning of the study, 4 weeks after the beginning of study, at the end of study. Method of measurement: Serum level measurement by the laboratory.;Serum albumin level. Timepoint: At the beginning of the study, 4 weeks after the beginning of study, at the end of study. Method of measurement: Serum level measurement by the laboratory.;Serum level of alkalin phosphatase. Timepoint: At the beginning of the study, 4 weeks after the beginning of study, at the end of study. Method of measurement: Serum level measurement by the laboratory.

—

Secondary

Measure	Time frame
Serum level of creatinine and urea. Timepoint: At the beginning of the study, 2 weeks after the beginning of study and at the end of 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