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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220208053971N1

Enrollment

Registered

2022-04-16

Start date

2022-04-02

Completion date

Unknown

Last updated

2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myeloid leukemia. Acute myeloblastic leukemia

Interventions

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 f

Eligibility

Sex/Gender

All

Age

20 Years to 55 Years

Inclusion criteria

Inclusion criteria: Diagnosis of acute myeloid leukemia Admission to the ward to start induction chemotherapy Willingness to cooperate

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Hamed Mohammadi

Tehran University of Medical Sciences

mohamadihd@gmail.com0098 21 889900285

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026