Investigation of the Radiation Protection Effect of Metformin Against Complications Caused by Radiation Therapy in Patients with Prostate Cancer: Randomized Clinical Trial

Sasan  Razmjoo; Mohsen  Cheki; Mohammad  Hosseini; Ali  Bagheri; Samira  Razaghi; Sina  Hosseini

doi:10.18502/jimc.v8i1.17067

Sasan Razmjoo Department of Radiotherapy, Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Mohsen Cheki Department of Medical Imaging and Radiation Sciences, Faculty of Paramedicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Mohammad Hosseini Department of Radiotherapy, Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Ali Bagheri Department of Radiotherapy, Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Samira Razaghi Department of Radiotherapy, Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Sina Hosseini Department of Radiotherapy, Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran

DOI: https://doi.org/10.18502/jimc.v8i1.17067

Keywords: Blood cells, Gastrointestinal diseases, Humans, Incidence, Male, Metformin, Prostatic neoplasms, Radiation-protective agents

Abstract

Background: External-Beam Radiation Therapy (EBRT) is one of the most important treatments for prostate cancer. Metformin is a multifunctional drug that can control complications following radiotherapy.

Methods: This double-blind, randomized clinical trial was conducted on patients with prostate cancer candidates for EBRT. Patients were randomly assigned to two groups receiving oral Metformin (n=20) or placebo (n=20). The incidence of acute complications was investigated using radiation therapy oncology group acute complications criteria.

Results: There was no significant change in the number of blood cells before and after treatment in the two groups (p<0.05). The micronuclei number in both groups showed a significant increase during radiotherapy, immediately and one month later (p<0.001). There was no significant difference in number of micronuclei between the two groups (p<0.05). The frequency of urinary complications ≥ grade 2 in the metformin group was lower (p=0.005). There was no significant difference in the incidence of gastrointestinal complications ≥ grade 2 between the metformin and placebo groups (p=0.5).

Conclusion: It is recommended that further studies on Metformin as a radioprotective agent in prostate cancer patients who are candidates for radiotherapy be carried out. This research project was registered in the clinical trial center (IRCT: IRCT20211213053377N1).