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IRCT20190813044526N1 IRCT 2019-09-23 Shiraz University of Medical Sciences The Effect of Metformin on Neuropathy The Evaluation of the Preventive Effect of Metformin on Paclitaxel-Induced Peripheral Neuropathy 2019-09-27 anticipated 60 Complete https://irct.ir/trial/41531 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this trial, subjects will be randomly assigned to one of two intervention and control groups using the random number table. There are no prerequisites for assigning individuals to groups. The randomization unit is individual. Each participant will have an equal chance of being placed in each group. In this study, blinding is done by the project colleagues and the patient will not know the contents of the drug.randomization with individual randomization unit, Blinding description: In this study, a single blinding will be performed, the patient will not be aware of the drug content. So, the patient considers it to be part of the treatment process and to control the side effects of chemotherapy. 2 Drug-induced Peripheral polyneuropathy. Intervention 1: Intervention group: Receiving 500 mg metformin Po Bid during chemotherapy with Paclitaxel. Intervention 2: Control group: Without receiving additional medications during chemotherapy. Yes - There is a plan to make this available What will be shared: Information about main outcomes of the study When: Six months after publishing the results To whom: Researchers in universities and scientific and research centers Conditions: In order to improve the treatment of the disease and subsequent research and with the permission of the authors Where to obtain: Department of radiation oncology of Shiraz university of medical sciences How to obtain: Sending the request in writing or by email to the authors Comments:
public Samineh Sadeghian
Forty-second room, Department of radiation oncology, Namazi hospital, Namazi square
Shiraz Iran (Islamic Republic of) 71937-11351 +98 71 3647 4320 sadeghian_s@sums.ac.ir Shiraz University of Medical Sciences scientific Ahmad Mosallaei
Thirty-Sixth room, Department of radiation oncology, Namazi hospital, Namazi square
Shiraz Iran (Islamic Republic of) 71937-11351 +98 71 3647 4320 mosalaa@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Non-diabetic patients with histologically confirmed cancer; scheduled to undergo paclitaxel chemotherapy for cancer. 18 years 75 years Female Patients with diabetes mellitus; A history of clinically significant hypersensitivity reaction to medications; Pregnancy; Patients who are currently using metformin; Metformin induced neuropathy at 12 week G62.0 Drug-induced polyneuropathy Prevention Other Intervention group: Receiving 500 mg metformin Po Bid during chemotherapy with Paclitaxel Control group: Without receiving additional medications during chemotherapy Prevention of paclitaxel-induced peripheral neuropathy. Timepoint: Before and after intervention (week 12). Method of measurement: Nerve conduction study. Side effects. Timepoint: Weekly during intervention course. Method of measurement: Taking a history from the patient. Shiraz University of Medical Sciences Approved 2019-07-30 Ethics committee of Shiraz University of Medical Sciences Faculty of medicine, Zand Avenue Shiraz Fars Iran (Islamic Republic of)