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IRCT20171105037262N5 IRCT 2020-10-18 Kashan University of Medical Sciences Evaluation of melatonin effect on breast cancer The effect of melatonin supplementation on tumor grading, pathologic findings, serum levels of biomarkers related to inflammation and oxidative stress in patient with breast cancer 2020-01-21 anticipated 40 Complete https://irct.ir/trial/48059 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is performed by the website (https://stattrek.com/statistics/random-number-generator.aspx). Block randomization with 1:1 allocation ratio is applied to have equal group sizes, Blinding description: All participants and researchers or outcomes evaluators are unaware of allocation of study groups. 3 Breast cancer. Intervention 1: Intervention group: Receiving chemotherapy and melatonin supplementation. Every night one hour prior to sleep, patients will orally receive two 5mg capsules of melatonin for 24 weeks. Neoadjuvant chemotherapy regimen consist of 4 cycle doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 every 14_21 days followed by 4 cycle paclitaxel 175mg/m2 every 14-21 days. Four to six week after completion of neoadjuvant chemotherapy the patient will undergo surgery. Intervention 2: Control group: Receiving chemotherapy and placebo. Neoadjuvant chemotherapy regimen consist of 4 cycle doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 every 14_21 days followed by 4 cycle paclitaxel 175mg/m2 every 14-21 days. Four to six week after completion of neoadjuvant chemotherapy the patient will undergo surgery. Patients will orally receive two placebo capsules (barij essence, Iran) one hour prior to sleep for 24 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Zatollah Asemi
Ghotb-e-ravandi
Kashan Iran (Islamic Republic of) 8715988141 +98 31 5546 3378 asemi_r@yahoo.com Kashan University of Medical Sciences scientific Zatollah Asemi
Ghotb-e-ravandi Blvd
Kashan Iran (Islamic Republic of) 8715988141 +98 31 5554 2999 asemi_r@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Having breast cancer at any stage undergoing neoadjuvant chemotherapy Above 25 years of age 25 years no limit Female Having renal and liver failure Abnormal blood test C50 Malignant neoplasm of breast Treatment - Drugs Treatment - Drugs Intervention group: Receiving chemotherapy and melatonin supplementation. Every night one hour prior to sleep, patients will orally receive two 5mg capsules of melatonin for 24 weeks. Neoadjuvant chemotherapy regimen consist of 4 cycle doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 every 14_21 days followed by 4 cycle paclitaxel 175mg/m2 every 14-21 days. Four to six week after completion of neoadjuvant chemotherapy the patient will undergo surgery. Control group: Receiving chemotherapy and placebo. Neoadjuvant chemotherapy regimen consist of 4 cycle doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 every 14_21 days followed by 4 cycle paclitaxel 175mg/m2 every 14-21 days. Four to six week after completion of neoadjuvant chemotherapy the patient will undergo surgery. Patients will orally receive two placebo capsules (barij essence, Iran) one hour prior to sleep for 24 weeks Tumor grade. Timepoint: At the beginning and end of intervention. Method of measurement: Microscopic. Serum levels of biomarkers related to inflammation and oxidative stress. Timepoint: At the beginning and end of interventio. Method of measurement: ELISA. Kashan University of Medical Sciences Approved 2019-12-14 Ethics committee of Kashan University of Medical sciences Ghotb-e-ravandi Blvd Kashan Isfehan Iran (Islamic Republic of)