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IRCT20251210068277N1 IRCT 2026-07-14 Tehran University of Medical Sciences Investigation the protective role of oral magnesium supplementation on Doxorubicin- induced cardiotoxicity Comparison of the Effectiveness of Magnesium Supplement with not Taking of Magnesium Supplement on Doxorubicin- Induced Cardiotoxicity in Breast Cancer Patients 2026-07-23 anticipated 80 Recruiting https://irct.ir/trial/88086 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: After meeting the inclusion criteria and obtaining informed consent, participants will be allocated in a 1:1 ratio to the intervention and control groups. The random sequence will be created using SPSS version 26 software and through the generation of random numbers (Random Number Generator). In order to maintain a balance in the number of people in the two groups during the study, a random block method with a block size of 4 will be used. 20 blocks of 4 will be formed, and each patient will receive a code in the order of entry. The allocation list will be prepared by someone outside the outcome assessment team and will be kept in opaque, sealed, numbered envelopes and sequentially stored. After each participant enters the study, the relevant envelope will be opened in numerical order and the allocation group will be determined. The cardiac outcome assessor (ECG and echocardiography) will not be aware of the group allocation of the patients. 2-3 breast cancer. Intervention 1: Intervention group: Patients with breast adenocarcinoma who have no history of receiving chemotherapy and are candidates for the doxorubicin and cyclophosphamide chemotherapy regimen will receive oral magnesium citrate supplement (product of Ofogh Pharmaceutical Company, Pars Pharmaceutical Manufacturing Company, with a concentration of 420 mg of elemental magnesium per tablet) at the same time as the start of the first cycle of chemotherapy with the standard doxorubicin and cyclophosphamide regimen (standard treatment includes doxorubicin at a dose of 60 mg/m2 and cyclophosphamide at a dose of 600 mg/m2, once every 14 days for a total of 4 cycles) in the amount of one tablet (420 mg) every twelve hours for 4 chemotherapy cycles (equivalent to 8 weeks). The method of administration will be oral, preferably after meals.Also, a 20-30 minute face-to-face educational session will be held for each patient by a member of the research team, which will include the correct way to take the supplement, possible gastrointestinal side effects and warning signs for stopping use, the importance of adhering to daily intake and monitoring cardiac symptoms, and how to contact the research team in case of any complications. Patients in this group will also receive all supportive and standard care in accordance with the department's protocol. Intervention 2: Control group: Patients with breast adenocarcinoma who have no history of chemotherapy and are candidates for the chemotherapy regimen of doxorubicin and cyclophosphamide will receive only standard treatment including doxorubicin and cyclophosphamide according to the center's treatment protocol including doxorubicin at a dose of 60 mg/m2 and cyclophosphamide at a dose of 600 mg/m2, once every 14 days for a total of 4 cycles, and will not receive any magnesium supplements during the study period. A face-to-face educational session for this group will also be held for 15 to 20 minutes by a member of the research team, the content of which will include an explanation of the importance of following up on cardiac symptoms and how to contact the research team in case of any complications. All supportive and standard care will also be provided for this group according to the department's protocol. 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 Patient-related data will be disseminated exclusively upon the unanimous approval of the faculty committee, strictly adhering to the established protocols for maintaining confidentiality.
public Dr.Farahnaz Jazaeri
Poursina Street, Engghelab Square
Tehran Iran (Islamic Republic of) 1461884513 +98 21 8889 6696 fjazaeri@gmail.com Tehran University of Medical Sciences scientific Dr. Farahnaz Jazaeri
Poursina Street, Engghelab Square
Tehran Iran (Islamic Republic of) 1461884513 +98 21 6405 9215 fjazaeri@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients who are being treated with a doxorubicin-containing drug regimen for the first time will be selected. All patients that breast adenocarcinoma is confirmed histopathologically in them and have negative human epidermal growth factor receptor 2 , grade 1 or 2 and stage 1 or 2 will undergo a chemotherapy regimen containing doxorubicin and cyclophosphamide (AC) will be included in the study. In order to control for confounding factors and reduce heterogeneity due to differences in treatment history and type of chemotherapy regimen, only patients with breast adenocarcinoma who had no history of chemotherapy and would be candidates for AC regimen were included in the study All patients will receive the standard AC chemotherapy regimen including: Doxorubicin (Adriamycin) 60mg/m2 and Cyclophosphamide 600mg/m2 each 2 weeks 4 times Normal kidney function (Glomerular filtration rate (GFR) > 60 milliliter in minute( ml/min), normal serum level of Blood urea nitrogen and creatinine (Bun and Cr)) Normal liver function (given that liver function tests (LFT) are normal). 18 years 65 years Female Underlying heart disease such as heart failure, arrhythmia, ischemic heart disease Age over 65 years Pre-existing hypermagnesemia hypomagnesemia Taking magnesium supplements within the past 21 days C50 Malignant neoplasm of breast Prevention N/A Intervention group: Patients with breast adenocarcinoma who have no history of receiving chemotherapy and are candidates for the doxorubicin and cyclophosphamide chemotherapy regimen will receive oral magnesium citrate supplement (product of Ofogh Pharmaceutical Company, Pars Pharmaceutical Manufacturing Company, with a concentration of 420 mg of elemental magnesium per tablet) at the same time as the start of the first cycle of chemotherapy with the standard doxorubicin and cyclophosphamide regimen (standard treatment includes doxorubicin at a dose of 60 mg/m2 and cyclophosphamide at a dose of 600 mg/m2, once every 14 days for a total of 4 cycles) in the amount of one tablet (420 mg) every twelve hours for 4 chemotherapy cycles (equivalent to 8 weeks). The method of administration will be oral, preferably after meals.Also, a 20-30 minute face-to-face educational session will be held for each patient by a member of the research team, which will include the correct way to take the supplement, possible gastrointestinal side effects and warning signs for stopping use, the importance of adhering to daily intake and monitoring cardiac symptoms, and how to contact the research team in case of any complications. Patients in this group will also receive all supportive and standard care in accordance with the department's protocol Control group: Patients with breast adenocarcinoma who have no history of chemotherapy and are candidates for the chemotherapy regimen of doxorubicin and cyclophosphamide will receive only standard treatment including doxorubicin and cyclophosphamide according to the center's treatment protocol including doxorubicin at a dose of 60 mg/m2 and cyclophosphamide at a dose of 600 mg/m2, once every 14 days for a total of 4 cycles, and will not receive any magnesium supplements during the study period. A face-to-face educational session for this group will also be held for 15 to 20 minutes by a member of the research team, the content of which will include an explanation of the importance of following up on cardiac symptoms and how to contact the research team in case of any complications. All supportive and standard care will also be provided for this group according to the department's protocol Left ventricular ejection fraction. Timepoint: Measurement of ejection fraction before the intervention and 2 weeks after the completion of the intervention. Method of measurement: Transthoracic echocardiography. Nonspecific ST-T changes on ECG. Timepoint: Before the intervention and 2 weeks after the completion of intervention. Method of measurement: Standard twelve-lead ECG recording. Plasma Troponin level. Timepoint: Before the intervention and 2 weeks after the completion of intervention. Method of measurement: Serum troponin measurement with a dedicated ELISA kit. Serum magnesium level. Timepoint: Before the intervention and 2 weeks after the completion of the intervention. Method of measurement: Measurement of serum magnesium concentration with a biochemistry autoanalyzer. Serum albumin level. Timepoint: Before the intervention and 2 weeks after the completion of the intervention. Method of measurement: Serum albumin measurement with an autobiochemistry analyzer. Serum lactate level. Timepoint: Before the intervention and 2 weeks after the completion of the intervention. Method of measurement: Serum lactate measurement with an autobiochemistry analyzer. Plasma fibrinogen level. Timepoint: Before the intervention and 2 weeks after the completion of the intervention. Method of measurement: Plasma fibrinogen measurement by coagulation method. Erythrocyte sedimentation rate(ESR). Timepoint: Before the intervention and 2 weeks after the completion of the intervention. Method of measurement: Measurement by Westergren method. C-reactive protein(CRP). Timepoint: Before the intervention and 2 weeks after the completion of the intervention. Method of measurement: Measurement with a dedicated kit using the ELISA method. Neutrophil to lymphocyte ratio. Timepoint: Before the intervention and 2 weeks after the completion of the intervention. Method of measurement: Calculation of the neutrophil to lymphocyte ratio based on the results of a complete blood cell count. Magnesium levels inside red blood cells. Timepoint: Before the intervention and 2 weeks after the completion of the intervention. Method of measurement: Measurement of red blood cell magnesium with a dedicated kit using the ELISA method. Tehran University of Medical Sciences Approved 2025-12-02 Imam Khomeini Hospital Ethics Committee No.19, Facing the Helicopter Runway, South-West Side, Office of the Vice President for Research in the Vice President for Academic Affairs, Imam Khomeini Hospital, Keshavarz Boulevard Tehran Tehran Iran (Islamic Republic of)