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IRCT20120707010205N10 IRCT 2022-09-19 Babol University of Medical Sciences Evaluation of the effects of quercetin ointment in the prevention of radiation-induced acute proctitis in prostate cancer patients Evaluation of the effects of quercetin ointment in the prevention of radiation-induced acute proctitis in prostate cancer patients 2022-05-22 anticipated 50 Complete https://irct.ir/trial/62867 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this method, packages containing medicine or placebo are placed in the box as a mixture, and when offered to the candidates, without looking inside the box, one of the packages is randomly selected and given to the candidate. The package containing the placebo is marked with the letter A and the package containing the medicine is marked with the letter B, Blinding description: For blinding, quercetin ointment and placebo are completely identical in terms of color, shape, consistency and smell, and are placed in the same containers so that the contents of the containers are not visible in terms of shape, color and consistency for the researcher and the patient. Somehow it is planned that neither the participant nor the researcher know which of the two control or test groups quercetin ointment or placebo is given. 3 Radiation proctitis. Intervention 1: Intervention group: concurrent with beginning of radiotheray,every day 5 cc of prepared quercetin ointment will be used by enema twice ingredients of quercetin ointment: chitosan,quercetin 2%,Carboxymethyl cellulose and sodium alginate substances will be from Sigma-Aldrich brand and will be combined in pharmacology laborartory,clean room of Babol University of Medical Sciences. Intervention 2: Control group: concurrent with beginning of radiotheray,every day 5 cc of prepared placebo ointment will be used by enema twice a day placebo ingredients: chitosan,Carboxymethyl cellulose, sodium alginate and edible food color (to make the combination look like quercetin ointment) substances will be from Sigma-Aldrich brand and will be combined in pharmacology laborartory,clean room of Babol University of Medical Sciences. 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 NO MORE INFORMATION
public Dr Dariush Moslemi
Department of Radiation Oncology, Babol University of Medical Sciences,
Babol Iran (Islamic Republic of) 4717647745 +98 11 1223 4143 moslemi_d@yahoo.com Babol University of Medical Sciences scientific Dr Dariush Moslemi
Department of Radiation Oncology, Babol University of Medical Sciences,
Babol, Iran (Islamic Republic of) 4717647745 +98 11 1223 4143 moslemi_d@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) prostate cancer patients undergoing radiotherapy with a field encompassing almost whole rectum and receive a minimum dose of 4000 cGy radiation no limit no limit Male Patients with history of previous radiotherapy of pelvis region Patients receiving treatment with anti-inflammatory drugs (NSAIDS, corticosteroids) Patients with inflammatory bowel disease (ulcerative colitis , Crohn's disease ) K62.7 Radiation proctitis Treatment - Drugs Placebo Intervention group: concurrent with beginning of radiotheray,every day 5 cc of prepared quercetin ointment will be used by enema twice ingredients of quercetin ointment: chitosan,quercetin 2%,Carboxymethyl cellulose and sodium alginate substances will be from Sigma-Aldrich brand and will be combined in pharmacology laborartory,clean room of Babol University of Medical Sciences Control group: concurrent with beginning of radiotheray,every day 5 cc of prepared placebo ointment will be used by enema twice a day placebo ingredients: chitosan,Carboxymethyl cellulose, sodium alginate and edible food color (to make the combination look like quercetin ointment) substances will be from Sigma-Aldrich brand and will be combined in pharmacology laborartory,clean room of Babol University of Medical Sciences Score of acute proctitis according to the staging system of the Radiation Oncology Group (RTOG). Timepoint: At the beginning of the study and then every week after the start of quercetin ointment consumption. Method of measurement: RTOG criteria to evaluate acute proctitis reaction induced by radiation therapy. Babol University of Medical Sciences Approved 2022-03-06 Ethics committee of Babol University of Medical Sciences Ganj afrooz street Babol Mazandaran Iran (Islamic Republic of)