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IRCT20170307032933N3 IRCT 2018-10-22 Ahvaz University of Medical Sciences Radiation Protection Effects of Metformin in Prostate Cancer The Investigating of Radiation Protection Effects of Metformin in Patients with Prostate Cancer Treated with Radiotherapy 2018-11-22 anticipated 60 Complete https://irct.ir/trial/34260 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: Assignment of patients in two groups of test and control will be done by Block Balanced Randomization (BBR) method. The Randomization Sequence will be generated with using the free website at http://www.randomization.com, Blinding description: This is a double-blind study. The patients know they are participating in an investigation that is aimed to evaluate the metformin effect on prostate cancer but they are not informed that they receive placebo or metformin. The physician who evaluates the clinical status of patients and the nurse who prescribe the drug are not aware of the medication that patients receive. Medications are similar in appearance, color, smell and taste. N/A Prostate cancer. Intervention 1: Intervention group: Metformin tablet at a dose of 1000 mg orally once a day will be prescribed before starting radiation therapy by one month after the final session of radiotherapy. Intervention 2: Control group: Placebo tablet at a dose of 1000 mg orally once a day will be prescribed before starting radiation therapy by one month after the final session of radiotherapy. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It is not yet known if there will be a plan to make this available
public Sasan Razmjoo
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
Ahvaz Iran (Islamic Republic of) 15794-61357 +98 61 3222 2818 razmjoo-s@ajums.ac.ir Ahvaz University of Medical Sciences scientific Mohsen Cheki
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
Ahvaz Iran (Islamic Republic of) 15794-61357 +98 61 3222 2818 mohsencheky@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Patients with localized prostate cancers that undergo definitive or postoperative external radiotherapy no limit no limit Male Patients with metastatic prostate cancer Patients previously treated with radiotherapy or chemotherapy Patients with renal or liver dysfunction Patients with severe respiratory diseases (such as obstructive pulmonary disorders or severe asthma) Patients with hematological disorders (such as severe anemia or vitamin B12 deficiency) Diabetic patients Smoker patients Metformin hypersensitivity C61 Malignant neoplasm of prostate Prevention Prevention Intervention group: Metformin tablet at a dose of 1000 mg orally once a day will be prescribed before starting radiation therapy by one month after the final session of radiotherapy Control group: Placebo tablet at a dose of 1000 mg orally once a day will be prescribed before starting radiation therapy by one month after the final session of radiotherapy Radiation protection effect. Timepoint: At 0, every two weeks during radiotherapy course and one month after the final session of radiotherapy. Method of measurement: Oxidative stress tests. Urogenital complications. Timepoint: At 0, every two weeks during radiotherapy course and one month after the final session of radiotherapy. Method of measurement: Toxicity Criteria of the Radiation Therapy Oncology Group. Ahvaz University of Medical Sciences Approved 2018-10-06 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd Ahvaz Khouzestan Iran (Islamic Republic of)