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IRCT20120922010901N7 IRCT 2020-07-26 Tabriz University of Medical Sciences The effect of metformin in patients with ovarian cancer The effect of metformin on the early outcome of patients undergoing ovarian cancer chemotherapy 2020-07-22 anticipated 90 Complete https://irct.ir/trial/49801 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into intervention and control groups using even and odd numbers, respectively. The number zero is considered as even. 3 Serum CA125 changes. Intervention 1: Intervention group: Metformin starts with a daily dose of 500 mg and during one week the dose will be increased to 1500 mg daily in three divided doses (500 mg every 8 hours). This group will also receive carboplatin – paclitaxel periodically (every 21 days). Intervention 2: Control group: Will receive carboplatin – paclitaxel periodically (every 21 days). Yes - There is a plan to make this available What will be shared: Study data related to the primary outcome variable will shared. When: Access starts 6 months after the results publication. To whom: Obstetricians and gynecology specialists will be allowed to receive data. Conditions: Study data will available after obtaining permission from the Vice Chancellor for Research. Where to obtain: The data can be obtained after coordination with the person in charge of updating the trial. How to obtain: Obtain permission from the person in charge of updating the trial Comments:
public Dr.Parvin Mostafa Gharabaghi
Tabriz University of Medical Sciences, Golgasht Street
Tabriz Iran (Islamic Republic of) 5138665793 +98 41 1553 9161 Gharabagh.p@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Dr. Parvin Mostafa Gharabaghi
Tabriz University of Medical Sciences, Golgasht Street
Tabriz Iran (Islamic Republic of) 5138665793 +98 41 1553 9161 gharabagh.p@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Confirmed ovarian epithelial cancer with pathology report Serum cancer antigen 125 level above 35 mg/dl Laparotomy and surgical tumor staging candidate 18 years no limit Female Diabetes Gastrointestinal disorders Kidney failure Metformin intolerance Having other cancers in addition to ovarian epithelial cancer Previous history of chemotherapy Serum cancer antigen 125 level equal and lower than 35 mg/dl R97.1 Elevated cancer antigen 125 [CA 125] Treatment - Drugs Treatment - Drugs Intervention group: Metformin starts with a daily dose of 500 mg and during one week the dose will be increased to 1500 mg daily in three divided doses (500 mg every 8 hours). This group will also receive carboplatin – paclitaxel periodically (every 21 days). Control group: Will receive carboplatin – paclitaxel periodically (every 21 days). Response to treatment. Timepoint: Three months after the intervention. Method of measurement: Serum level of cancer antigen 125. Tabriz University of Medical Sciences Approved 2020-06-28 Ethics committee of Tabriz University of Medical Sciences Faculty of medicine, Daneshgah Ave. Pish-Ghadam Ave. Tabriz East Azarbaijan Iran (Islamic Republic of)