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IRCT20211213053377N1 IRCT 2022-01-20 Ahvaz University of Medical Sciences The radioprotective effect of metformin against radiotherapy-induced complications The investigating of radioprotective effect of metformin against radiotherapy-induced urinary, gastrointestinal complications and genotoxicity in prostate cancer patients 2022-01-21 anticipated 60 Complete https://irct.ir/trial/60641 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be assigned into two groups by simple randomization method. Allocation of patients to the study groups will be done by random numbers generation and using computer by excel software. Random numbers will be generated in Excel with RAND function [(=RAND()*(60)] and with this function 60 random numbers will be created in the range of 1 to 60 in a column. Each patient will be assigned a two-digit code from 01 to 60. From the beginning of the first row, move down the column of random numbers and check the first two digits of the random numbers. The first 30 people seen in our code range will be placed in the first group (intervention) and the second 30 people will place in the second group (control). A person from hospital staff, who will not responsible for patient selection, enrollment, or treatment allocation, performs the randomization. The patients will be included in one of the two treatment groups before starting radiotherapy. The implementation of the random allocation sequence occurs without knowledge of which patient will receive which treatment, Blinding description: Intervention (receiving oral metformin or placebo) and patient evaluation will be carried out by a physician who is blinded to both treatment groups. Also patients and statistical analyzer will not know about patient grouping. 3 Prostate cancer. Intervention 1: Intervention group: Patients will receive oral metformin tablets (Chemi Darou Pharmaceutical Company, Iran) at a single dose of 1000 mg per day before the start of radiotherapy until one month after radiotherapy. Metformin tablets will be taken 2 hours before radiotherapy. Intervention 2: Control group: In the second group, patients will receive a placebo with a similar dose of 1000 mg per day before the start of radiotherapy until one month after radiotherapy. The appearance of a placebo is similar to that of metformin. 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 There is no more information.
public Sina Hosseini
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3001 3374 Larkhilv@gmail.com Ahvaz University of Medical Sciences scientific Sina Hosseini
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3001 3374 Larkhilv@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Patients localized prostate adenocarcinoma cancer Prescribe of definitive or postoperative external beam radiotherapy Consent to participate in the study 18 years no limit Male Patients with metastatic prostate cancer Previous history of radiation or chemotherapy Renal and hepatic dysfunction Patients with cardiovascular failure Patients with severe respiratory problems (such as obstructive pulmonary disease, severe asthma) Patients with blood problems (such as anemia, vitamin B12 deficiency) Diabetic patients Smoking patients C61 Malignant neoplasm of prostate Treatment - Drugs Treatment - Drugs Intervention group: Patients will receive oral metformin tablets (Chemi Darou Pharmaceutical Company, Iran) at a single dose of 1000 mg per day before the start of radiotherapy until one month after radiotherapy. Metformin tablets will be taken 2 hours before radiotherapy. Control group: In the second group, patients will receive a placebo with a similar dose of 1000 mg per day before the start of radiotherapy until one month after radiotherapy. The appearance of a placebo is similar to that of metformin. The Number of blood cells. Timepoint: Before first session of radiotherapy, once every two weeks during radiation therapy and one months after the end of radiotherapy. Method of measurement: Laboratory measurement of blood cell count. Genotoxicity. Timepoint: Before first session of radiotherapy, once every two weeks during radiation therapy and one months after the end of radiotherapy. Method of measurement: Laboratory count of micronucleus in peripheral blood lymphocytes. Urinary complications. Timepoint: Before first session of radiotherapy, once every two weeks during radiation therapy and one months after the end of radiotherapy. Method of measurement: Evaluation of acute urinary complications due to radiation therapy based on physician examination and patient symptoms. Gastrointestinal complications. Timepoint: Before first session of radiotherapy, once every two weeks during radiation therapy and one months after the end of radiotherapy. Method of measurement: Evaluation of acute gastrointestinal complications due to radiation therapy based on physician examination and patient symptoms. Ahvaz University of Medical Sciences Approved 2021-06-18 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd. Ahvaz Khouzestan Iran (Islamic Republic of)