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

determine 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

In this randomized clinical trial, Phase 2 will be taken from 68 patients using a general information questionnaire. Anthropometric measurements will be taken before the intervention begins. Three 24-hour food records will be taken from patients at the beginning, middle and end of the study, and their quality of life scores will be assessed using the EORTC QLQ-C30 questionnaire before the intervention and at the end of the intervention. To better follow the intervention, people will be consulted face to face twice a week

This study will be performed as a clinical trial on patients with acute myeloid leukemia under induction chemotherapy. Participants will be selected from patients admitted to Shariati Hospital in Tehran in 1400 based on the inclusion criteria.

Adults with AML undergoing induction chemotherapy, aged 20-55 years, will be enrolled in the absence of active infection at the time of admission and with a Karnofsky Performance Scale Index of more than 70%, and individuals with chronic obstructive pulmonary disease will fail. Chronic kidney, diabetes and asthma will not be included in the study.

The neutropenic diet group uses neutropenic guidelines for 4 weeks. Participants in the Food Safety guidelines Group will receive detailed information, including how to buy, prepare, store, cook, and how to serve and consume food safely, for 4 weeks

Early onset of fever and neutropenia; Quality of Life ; Incidence of bacteremia; Incidence of pneumonia; Incidence of fungal infections; Duration of use of antibiotics or antifungals; Incidence of infectious diarrhea

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.

Due to confidentiality of participant information, it is not possible to publish it