The investigating of radioprotective effect of metformin against radiotherapy-induced urinary, gastrointestinal complications and genotoxicity in prostate cancer patients

The investigating of radioprotective effect of metformin against radiotherapy-induced urinary, gastrointestinal complications and genotoxicity in prostate cancer patients

This is a clinical trial study with parallel groups, double-blinded randomized, will be conducted on 60 patients with prostate cancer candidate for radiotherapy. Assignment of patients to the study groups will be done by random numbers generation and using computer by excel software.

This double-blinded study will be performed on 60 patients with prostate cancer candidate for radiotherapy in Golestan hospital, Ahvaz. The patients will be randomly assigned to one of two treatment groups of metformin or placebo. The patients and experimenters will not know about type of treatment and patient grouping.

Inclusion criteria: Patients localized prostate adenocarcinoma cancer, Prescribe of definitive or postoperative external beam radiotherapy, Consent to participate in the study; Exclusion criteria: Patients with metastatic prostate cancer, Previous history of radiation or chemotherapy, Renal and hepatic dysfunction, Patients with cardiovascular failure, Patients with severe respiratory problems, Patients with blood problems, Diabetic patients, Smoking patients.

In first 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. 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 Number of blood cells, Genotoxicity, Urinary and gastrointestinal complications

The reason for this update is a mistake in registering the title of the trial. The ethics code which obtained and registered is related to this new title.

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.

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.