IRCT20211029052907N3 IRCT 2022-03-12 Zanjan University of Medical Sciences Evaluation of metformin gel effect on prevention of radiation acute dermatitis Effectiveness and safety of Metformin gel in prevention of acute radiation dermatitis in breast cancer patients (a randomized, double-blind, placebo-controlled clinical trial) 2022-04-04 anticipated 52 Complete https://irct.ir/trial/62278 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be randomly assigned into 2 groups with the help of a computer-generated random assignment by an independent statistician who was not part of the study team. Allocation will be concealed using sequentially numbered opaque sealed envelopes, Blinding description: Eligible participants after signing the informed consent form will be randomly allocated to receive the Metformin gel or the placebo using a computer-generated random number list prepared by an investigator without any clinical involvement. The patient, the researcher, and the radiation-oncologist were not aware of the patients’ allocated gel. 3 Acute radiation dermatitis. Intervention 1: Intervention group: intervention group will use metformin gel which is made in laboratory, for 2 times a day from the first session of radiotherapy to 4 weeks after the last session. In each time a thin layer of gel will be consumed on the area exposed to the radiation. Intervention 2: Control group: placebo gel. 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.