Forty patients with non-metastatic breast cancer treated with an adriamycin+cyclophosphamide regimen who have grade 2 hepatic toxicity based on NCI-CTC version4 randomly (according to a computerized list provided by randomization.com site) will assigned to one of two drug or placebo groups. Twenty patients in the drug group will receive Livergol tablets containing 140 mg of silymarin three times a day after each meal, and twenty patients in the placebo group will receive tablets similar in appearance to Livergol which contain non-active ingredients of the Livergol tablet. The liver function tests including hepatic transaminases, bilirubin (total and direct), albumin and alkaline phosphatase will be performed at the beginning of the study,after two weeks and at the end of the first month. Liver ultrasound will be done at the beginning of the study and after a month. Also, liver fibroscan will be done at the end of a month for a closer look. Then the liver status will be compared between the two groups of drugs and placebo.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017091136125N1
Registration date:2017-10-24, 1396/08/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-24, 1396/08/02
Registrant information
Name
Ghazal Saadat Askarpour Moezian
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3764 9222
Email address
asgarpourgh921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Gol daroo Pharmaceutical Company, Isfahan, Iran
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of silymarin oral form on the control of liver toxicity caused by AC regimn in patients with non metastatic breast cancer
Public title
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
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 18 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences