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IRCT20131218015860N7 IRCT 2021-11-16 School of Traditional Medicine, Traditional Medicine and Materia Medica Research Center,Shahid Behes Evaluation of the effects of the cardioprotective diet on prevention of the incidence of cardiotoxicity Evaluation of the effects of the cardioprotective diet on prevention of the incidence of cardiotoxicity in patients with breast cancer receiving Anthracycline 2021-11-11 anticipated 60 Complete https://irct.ir/trial/58484 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, randomization is first done by random sequence generation. A simple randomization method will be used to generate a random sequence. The method of simple randomization in this study is the use of a random number table. A random number table is a set of numbers that are generated without a specific pattern or order and in a completely random form and has become a table. In order to use the table of random numbers, we first preset the table to read the numbers (from left to right). Then the numbers are considered for the study groups so that even numbers will be considered for the experimental group and odd numbers will be considered for the control group. The second step is the concealment of the randomization allocation because the assigned group will not be specified before the individual is assigned. In this study, due to the fact that sampling is multicenter, the central randomization method will be used to hide the allocation. In this method, the random sequence is given to a person in the school of Traditional Medicine and sampling is performed in three centers. Based on the order in which the participants entered the study, the researcher contacted the mentioned person in the School of Traditional Medicine and asked about the random assignment of the participant to the experimental or control group. Communication methods include the use of telephone, SMS, fax, e-mail, and so on, Blinding description: Blindness in this study is single blind. This means that patients receive similar packages and they do not know that the intervention group is receiving an extra sheet containing heart-protective dietary recommendations. 3 cardiotoxicity in patients with breast cancer receiving Anthracycline. Intervention 1: Intervention group: The recipient of the diet protects the heart. First, a history is taken of the patients who have entered the study and completed the consent form. All patients are evaluated for weight, height, blood pressure, and demographic information, and patient tests are recorded. Both groups will receive chemotherapy with anthracyclines +/- trastuzumab (Herceptin) and other recommendations and the usual care, in addition to the above, the experimental group will receive a diet rich in heart tonics. This diet is similar to the diet recommended by Mozaffarian, which uses foods that are recommended as heart protectors. Since there is no standard guideline or standard protocol to prevent cardiovascular complications, in this study, the recommended diet for the participants of the experimental group is based on the Mozaffarian proposed diet. Dr. Mozaffarian et al. - are nutritionists who have focused on cardiovascular health for many years and have conducted numerous epidemiological studies on nutrition and the prevention of cardiovascular disease - they suggest a nutrient-based diet as a healthy diet for the heart. Intervention 2: Control group: Patients who have entered the plan and completed the consent form will have a history. All patients are evaluated for weight, height, blood pressure, and demographic information and tests are recorded. Both groups of chemotherapy with anthracyclines +/- trastuzumab (Herceptin) and other recommendations and care Receive the usual, the control group will not receive CpD. 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
public Ghazaleh Heydarirad
No.8 Shams Alley, opposite St tavanir, Vali Asr Street, Tehran
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 6027 dr.ghazalrad@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Ghazaleh Heydarirad
No.8 Shams Alley, opposite St tavanir, Vali Asr Street, Tehran
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 6027 dr.ghazalrad@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Women age 18-65 Breast cancer (based on pathology response) Candidate for chemotherapy including anthracyclines +/- trastuzumab 25 ≤BMI ≤ 19 Willingness to participate in the study 18 years 65 years Female History of heart failure History of coronary artery disease Symptoms of heart failure (functional shortness of breath, orthopedics, PND) Ejection Fraction less than or equal to 40 Use of beta-blockers or ACEI Change the chemotherapy regimen for any reason Unwillingness to continue the study Follow less than 70% of trained dietary recommendations History of liver disease (except grade 1 and 2 fatty liver) History of kidney disease (other than history of urinary stones) • History of depression (taking antidepressants) BMI greater than 25 and less than 19 C00-C97 Malignant Neoplasms Prevention Placebo Intervention group: The recipient of the diet protects the heart. First, a history is taken of the patients who have entered the study and completed the consent form. All patients are evaluated for weight, height, blood pressure, and demographic information, and patient tests are recorded. Both groups will receive chemotherapy with anthracyclines +/- trastuzumab (Herceptin) and other recommendations and the usual care, in addition to the above, the experimental group will receive a diet rich in heart tonics. This diet is similar to the diet recommended by Mozaffarian, which uses foods that are recommended as heart protectors. Since there is no standard guideline or standard protocol to prevent cardiovascular complications, in this study, the recommended diet for the participants of the experimental group is based on the Mozaffarian proposed diet. Dr. Mozaffarian et al. - are nutritionists who have focused on cardiovascular health for many years and have conducted numerous epidemiological studies on nutrition and the prevention of cardiovascular disease - they suggest a nutrient-based diet as a healthy diet for the heart. Control group: Patients who have entered the plan and completed the consent form will have a history. All patients are evaluated for weight, height, blood pressure, and demographic information and tests are recorded. Both groups of chemotherapy with anthracyclines +/- trastuzumab (Herceptin) and other recommendations and care Receive the usual, the control group will not receive CpD. Left ventricular ejection fraction. Timepoint: In weeks 0, 8 and 18 from the beginning of the intervention. Method of measurement: Echocardiography. LV global longitudinal Strain (GLS). Timepoint: In weeks 0, 8 and 18 from the beginning of the intervention. Method of measurement: Echocardiography. Alteration of the cardiac marker troponin. Timepoint: Weeks 0, 8 and 18 from the beginning of the intervention. Method of measurement: blood test (Measurement of cardiac troponin enzyme). This enzyme is measured by the enzyme immunoassay method according to standard conditions with ELISA device and with a series of calibrated pipettes. Quality of Life. Timepoint: Weeks 0, 8 and 18 from the beginning of the intervention. Method of measurement: Quality of Life Questionnaire (EORTC - QOL Br23). School of Traditional Medicine, Traditional Medicine and Materia Medica Research Center,Shahid Behes Approved 2021-08-15 Vice-Chancellor in Research Affairs - Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical sciences, Daneshju Blv. Tehran Tehran Iran (Islamic Republic of)