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IRCT20200408046990N13 IRCT 2023-09-04 Mashhad University of Medical Sciences 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 2023-09-23 anticipated 70 Complete https://irct.ir/trial/71305 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Blocked randomization using website https://www.sealedenvelope.com With the explanation that each block has 4 members and the shape of the blocks can be as follows: [ABAB], [ABBA, [AABB],[BBAA],[BABA][BAAB] Code A belongs to the intervention group and code B belongs to the control group. the mentioned website selects 18 blocks from Quadruple blocks and patients will be assigned to blocks in the order of entry into the study and finally 70 patients will enter the study, Blinding description: The nano Silymarin and placebo capsule (prepared by Mashhad Pharmacy School) will be packaged in boxes with same appearance and delivered to the clinician. Patients who meet the inclusion criteria are selected by clinician to be included in the study and will receive a box filled with medication or placebo respectively. Patients will be evaluated during the treatment course by the physician. Data collection and analysis will be performed by the pharmacy student and the clinical pharmacist. All of them will be unaware patients' grouping until the end of the study and data analysis. 3 Non-metastatic breast cancer. 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 breakfast and dinner, for 8 week, oral. Yes - There is a plan to make this available What will be shared: The findings will be published in an article. Study protocol and statistical analysis will be used for article publication. When: One year after the end of the study it will be published and available in databases. To whom: If the funding sponsor allowed, the findings will be available for researchers, clinicians, and scientific centers. Conditions: The other researchers can use our findings in their review articles and meta analysis. Where to obtain: For this purpose, you can contact with Sepideh Elyasi, at Clinical Pharmacy Department, School of Pharmacy, Vakil Abad Aven., Mashhad, Iran. Email: elyasis@mums.ac.ir How to obtain: After receiving the query, dependent on the requested data, the scientific responsible person of the study will response to the query in coordinate with the sponsor within 2 weeks Comments:
public Sepideh Elyasi
Faculty of Pharmacy; Ferdowsi University; Vakilabad Boulevard
Mashhad Iran (Islamic Republic of) 17871 91886 +98 51 3180 1588 elyasis@mums.ac.ir Mashhad University of Medical Sciences scientific Sepideh Elyasi
Faculty of Pharmacy; Ferdowsi University; Vakilabad Boulevard
Mashhad Iran (Islamic Republic of) 17871 91886 +98 51 3180 1588 elyasis@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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 18 years 65 years Female 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 C50 Malignant neoplasm of breast Treatment - Drugs Placebo Intervention group: sinalive 70mg twice daily after breakfast and dinner , oral, for 8 weeks Control group: Placebo capsule for sinalive, two tablet daily after breakfast and dinner, for 8 week, oral 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. 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. Mashhad University of Medical Sciences Approved 2023-05-20 Ethics committee of Mashhad University of Medical Sciences Qureshi Building, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)