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IRCT20220208053971N1 IRCT 2022-04-16 Tehran University of Medical Sciences The effects of food safety guidelines in comparison to the neutropenic diet on infection rates in patients with acute myeloid leukemia The effects of food safety guidelines in comparison to the neutropenic diet on infection rates in patients with acute myeloid leukemia undergoing remission induction chemotherapy: a randomized clinical trial 2022-04-02 anticipated 68 Complete https://irct.ir/trial/62191 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Permuted Block Randomization method is used for randomization. In this method, eligible individuals with inclusion criteria are selected and then they are randomly selected using blocks with the size of 4 subjects, that blocks will be based on age (20 to 40 and 40 to 55 years) and gender (female / male). Then all possible sequences that can be written with block size of 4, were written on paper (for two groups with block size of 4, 6 sequences can be written). Then one of the numbers from 1 to 6 was considered for each sequence, for example for the ABBA sequence 1 and for the AABB sequence 2 and as such, one of the numbers 3 to 6 was considered for the other 4 sequences. Then, using random number table, the random numbers were selected from one point to the left or right. Wherever the random number was 1 to 6, the corresponding sequence was recorded on the paper, and wherever the numbers were 0 or 7, 8, 9, the next number that was between 1 to 6 was considered. This method continued until groups for the total number of participants were determined. Then, the names of subjects on the list were allocated to the specific groups according to the sequence of groups which had been determined by the above-mentioned procedure. 2 Acute myeloid leukemia. Intervention 1: Intervention group: The group of food safety guidelines will receive detailed information including how to buy, prepare, store, cook and how to serve and consume food safely and will follow this guidelines for 4 weeks. In order to assess the adherence of patients' diets during the intervention, three 24-hour 3-day food records will be taken from patients at the beginning, middle and end of the intervention. Quality of life scores will be assessed using the EORTC QLQ-C30 questionnaire before the intervention and at the end of the intervention. In order for people to better follow the intervention, face-to-face counseling will be done twice a week, and possible problems related to diet adherence will be examined and the necessary instructions will be provided. Intervention 2: Intervention group: The neutropenic diet group uses standard neutropenic guidelines that generally include the elimination of raw fruits and vegetables, soft cheeses, probiotic yogurt, undercooked meat and eggs, and tap water, spices, and alcoholic beverages. They will follow this diet for 4 weeks. In order to assess the adherence of patients' diets during the intervention, three 24-hour 3-day food records will be taken from patients at the beginning, middle and end of the intervention. Quality of life scores will be assessed using the EORTC QLQ-C30 questionnaire before the intervention and at the end of the intervention. In order for people to better follow the intervention, face-to-face counseling will be done twice a week, and possible problems related to diet adherence will be examined and the necessary instructions will be provided. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to confidentiality of participant information, it is not possible to publish it
public Dr. Hamed Mohammadi
No. 44, Shahid Hojjat Doost Alley, Naderi St, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1416643931 0098 21 889900285 mohamadihd@gmail.com Tehran University of Medical Sciences scientific Dr, Hamed Mohammadi
No. 44, Shahid Hojjat Doost Alley, Naderi St, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1416643931 0098 21 889900285 mohamadihd@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Diagnosis of acute myeloid leukemia Admission to the ward to start induction chemotherapy Willingness to cooperate 20 years 55 years Both Infection or febrile illness at the time of admission Karnofsky Performance Status Scale less than 70% Chronic obstructive pulmonary disease, chronic renal failure, diabetes and asthma C92.0 Acute myeloblastic leukemia Prevention Prevention Intervention group: The group of food safety guidelines will receive detailed information including how to buy, prepare, store, cook and how to serve and consume food safely and will follow this guidelines for 4 weeks. In order to assess the adherence of patients' diets during the intervention, three 24-hour 3-day food records will be taken from patients at the beginning, middle and end of the intervention. Quality of life scores will be assessed using the EORTC QLQ-C30 questionnaire before the intervention and at the end of the intervention. In order for people to better follow the intervention, face-to-face counseling will be done twice a week, and possible problems related to diet adherence will be examined and the necessary instructions will be provided. Intervention group: The neutropenic diet group uses standard neutropenic guidelines that generally include the elimination of raw fruits and vegetables, soft cheeses, probiotic yogurt, undercooked meat and eggs, and tap water, spices, and alcoholic beverages. They will follow this diet for 4 weeks. In order to assess the adherence of patients' diets during the intervention, three 24-hour 3-day food records will be taken from patients at the beginning, middle and end of the intervention. Quality of life scores will be assessed using the EORTC QLQ-C30 questionnaire before the intervention and at the end of the intervention. In order for people to better follow the intervention, face-to-face counseling will be done twice a week, and possible problems related to diet adherence will be examined and the necessary instructions will be provided. The first episode of fever. Timepoint: From the first day of intervention for 4 weeks. Method of measurement: Temperatures above 38.3 degrees at one time or above 38 at two times with an interval of one hour. Incidence of bacteremia. Timepoint: From the first day of intervention for 4 weeks. Method of measurement: Patient file. Incidence of pneumonia. Timepoint: From the first day of intervention for 4 weeks. Method of measurement: Patient file. Incidence of fungal infections. Timepoint: From the first day of intervention for 4 weeks. Method of measurement: Patient file. Duration of use of antibiotics or antifungals. Timepoint: From the first day of intervention for 4 weeks. Method of measurement: Patient file. Infectious diarrhea. Timepoint: From the first day of intervention for 4 weeks. Method of measurement: Patient file. Type of documented organisms. Timepoint: From the first day of intervention for 4 weeks. Method of measurement: Patient file. Average length of hospital stay. Timepoint: From the first day of intervention for 4 weeks. Method of measurement: Patient file. Quality of Life. Timepoint: Beginning and end of the study. Method of measurement: EORTC QLQ-C30 Questionnaire. Number of infections per 1000 patient-day. Timepoint: From the first day of intervention for 4 weeks. Method of measurement: Patient file. Nutritional status. Timepoint: Beginning and end of the study. Method of measurement: PG-SGA questionnaire. Following the prescribed regimen. Timepoint: First, middle and end of the study. Method of measurement: Three 24-hour food records. Tehran university of medical science Approved 2022-02-21 Ethics committee of Tehran University of Medical sciences Room 605, Sixth Floor, Central Building of Tehran University of Medical Sciences, Qods Street, Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)