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IRCT20220409054463N1 IRCT 2022-04-27 Shahid Beheshti University of Medical Sciences Metformin as a chemotherapeutic agent Evaluation of using metformin on ki-67 tumor marker gene expression in endometrial cancer patients referred to Imam Hossein and Mahdie hospital, beween 1401-1402 2022-06-21 anticipated 40 Complete https://irct.ir/trial/63034 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization, using the Rand function of Excel software, Blinding description: The study is double-blind, and the patient, caregiver, and researcher do not know which category the patient is in (metformin or placebo). 1-2 Endometrial carcinoma. Intervention 1: Intervention group: In this study, we intend to refer patients with endometrial cancer who have been referred to Mahdieh / Imam Hossein (AS) Hospital, and are on the list of gynecological surgeries of this hospital, regardless of histological and surgical staging, for at least 4 weeks. Metformin 500 mg tablets are given orally every 8 hours. For each volunteer a form containing basic personal information and demographic information including age, BMI at the time of admission and day of surgery, pregnancy and parity, underlying disease, smoking, menopause, date of first diagnosis And the suggested time for surgery is filled. Patients with the above criteria, after filling out the form related to the initial information, an endometrial sample prepared by pipelle biopsy or curettage will be sent to the pathology department of Imam Hossein Hospital for examination and staining of ki-67 and p-53. And is examined by one pathologist. Patients are given a box of 100 metformin 500 tablets. Explanations about how to take the drug, its side effects, including gastrointestinal symptoms and symptoms of hypoglycemia, etc., and a contact number to communicate with patients participating in the project will be given to the patient by the medical team. All patients will receive treatment according to standard guidelines, and metformin will be discontinued 48 hours before anesthesia to prevent the risk of lactic acidosis. Intervention 2: Control group: In this study, we intend to refer patients with endometrial cancer who have been referred to Mahdieh / Imam Hossein (AS) Hospital, and are on the list of gynecological surgeries of this hospital, regardless of histological and surgical staging, for at least 4 weeks. Metformin 500 mg tablets are given orally every 8 hours. For each volunteer a form containing basic personal information and demographic information including age, BMI at the time of admission and day of surgery, pregnancy and parity, underlying disease, smoking, menopause, date of first diagnosis And the suggested time for surgery is filled. Patients with the above criteria, after filling out the form related to the initial information, an endometrial sample prepared by pipelle biopsy or curettage will be sent to the pathology department of Imam Hossein Hospital for examination and staining of ki-67 and p-53. And is examined by one pathologist. Patients are given a box of 100 placebo tablets similar to metformin 500 tablets. Explanations about how to take the drug, its side effects, including gastrointestinal symptoms and symptoms of hypoglycemia, etc., and a contact number to communicate with patients participating in the project will be given to the patient by the medical team. All patients will receive treatment according to standard guidelines, and metformin will be discontinued 48 hours before anesthesia to prevent the risk of lactic acidosis. Yes - There is a plan to make this available What will be shared: Data collected for the primary outcome measure will be shared. When: 6 month after publication To whom: Data are available for people working in academic institutions and businesses. Conditions: Data could be used for meta-analysis. Where to obtain: An e-mail in English should be sent to the main executor of the project (Dr. Minoo Rostami) and in addition to introducing the relevant person and organization, the type of data analysis and how to use it in the study should be fully mentioned. drminoorstmi@gmail.com How to obtain: After sending the email to the above address, within 10 working days, the email will be answered and if the use of information, etc. is clear, the information will be provided to the researchers. Comments:
public Minoo Rostami
Koodakiar street, Shahid beheshti medical university
Tehran Iran (Islamic Republic of) 1985717443 +98 21 6615 9710 drminoorstmi@gmail.com Shahid Beheshti University of Medical Sciences scientific Minoo Rostami
Koodakiar street, Shahid beheshti medical university
Tehran Iran (Islamic Republic of) 1985717443 +98 21 6615 9710 drminoorstmi@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) All women with endometrial carcinoma pathology, regardless of age and histological stage, who have referred to Mahdieh / Imam Hossein (AS) Medical Center between 1401-1402 and are on the list of staging surgery of this center. 20 years no limit Female Pregnancy Diabetes or the use of metformin or other blood sugar control drugs Liver or kidney dysfunction Simultaneous cancers over the last 5 years Use of chemotherapy drugs or hormone therapy during the last 3 months Any allergy to Biguanides or contraindications to the use of this class of drugs C54.1 Malignant neoplasm of endometrium Treatment - Drugs Treatment - Drugs Intervention group: In this study, we intend to refer patients with endometrial cancer who have been referred to Mahdieh / Imam Hossein (AS) Hospital, and are on the list of gynecological surgeries of this hospital, regardless of histological and surgical staging, for at least 4 weeks. Metformin 500 mg tablets are given orally every 8 hours. For each volunteer a form containing basic personal information and demographic information including age, BMI at the time of admission and day of surgery, pregnancy and parity, underlying disease, smoking, menopause, date of first diagnosis And the suggested time for surgery is filled. Patients with the above criteria, after filling out the form related to the initial information, an endometrial sample prepared by pipelle biopsy or curettage will be sent to the pathology department of Imam Hossein Hospital for examination and staining of ki-67 and p-53. And is examined by one pathologist. Patients are given a box of 100 metformin 500 tablets. Explanations about how to take the drug, its side effects, including gastrointestinal symptoms and symptoms of hypoglycemia, etc., and a contact number to communicate with patients participating in the project will be given to the patient by the medical team. All patients will receive treatment according to standard guidelines, and metformin will be discontinued 48 hours before anesthesia to prevent the risk of lactic acidosis. Control group: In this study, we intend to refer patients with endometrial cancer who have been referred to Mahdieh / Imam Hossein (AS) Hospital, and are on the list of gynecological surgeries of this hospital, regardless of histological and surgical staging, for at least 4 weeks. Metformin 500 mg tablets are given orally every 8 hours. For each volunteer a form containing basic personal information and demographic information including age, BMI at the time of admission and day of surgery, pregnancy and parity, underlying disease, smoking, menopause, date of first diagnosis And the suggested time for surgery is filled. Patients with the above criteria, after filling out the form related to the initial information, an endometrial sample prepared by pipelle biopsy or curettage will be sent to the pathology department of Imam Hossein Hospital for examination and staining of ki-67 and p-53. And is examined by one pathologist. Patients are given a box of 100 placebo tablets similar to metformin 500 tablets. Explanations about how to take the drug, its side effects, including gastrointestinal symptoms and symptoms of hypoglycemia, etc., and a contact number to communicate with patients participating in the project will be given to the patient by the medical team. All patients will receive treatment according to standard guidelines, and metformin will be discontinued 48 hours before anesthesia to prevent the risk of lactic acidosis. Changes in the expression of ki-67 gene in tissue samples of endometrial cancer after using metformin. Timepoint: Before treatment and on the day of surgery. Method of measurement: Ki-67 tissue staining (IHC). Changes in p-53 gene expression in endometrial cancer tissue samples after metformin use. Timepoint: Before treatment and on the day of surgery. Method of measurement: P-53 tissue staining (IHC). Determining the effect of metformin on tumor size reduction. Timepoint: Before treatment and on the day of surgery. Method of measurement: Measurement of mass during diagnosis by ultrasound and by the surgeon. Determining the effect of metformin use in reducing body mass index. Timepoint: Before treatment and on the day of surgery. Method of measurement: Measuring Body Mass Index (weight over height^2). Changes in p-53 gene expression in endometrial cancer tissue samples after metformin use. Timepoint: Before treatment and on the day of surgery. Method of measurement: P-53 tissue staining (IHC). Determining the effect of metformin on tumor size reduction. Timepoint: Before treatment and on the day of surgery. Method of measurement: Measurement of mass during diagnosis by ultrasound and by the surgeon. Determining the effect of metformin use in reducing body mass index. Timepoint: Before treatment and on the day of surgery. Method of measurement: Measuring Body Mass Index (weight over height^2). Shahid Beheshti University of Medical Sciences Approved 2022-04-15 Ethics committee of Shahid Beheshti University of Medical Sciences Koodakiar street, Shahid Beheshti medical University Tehran Tehran Iran (Islamic Republic of)