Moody, K., Finlay, J., Mancuso, C., & Charlson, M. (2006). Feasibility and safety of a pilot randomized trial of infection rate: Neutropenic diet versus standard food safety guidelines. Journal of Pediatric Hematology/Oncology, 28, 126–133.

The purpose of the study is to demonstrate a safe and feasible methodology to evaluate the infection rate in pediatric patients with cancer randomized to the neutropenic diet or the U.S. Food and Drug Administration (FDA)-approved food safety guidelines.

Pediatric patients (aged 1–21 years) undergoing myelosuppressive chemotherapy were randomized to receive a neutropenic diet or a diet based on the FDA food safety guidelines (emphasis on safe handling and cooking). Patients were enrolled during one cycle of chemotherapy.

Primary outcome was febrile neutropenia.  
Secondary outcome was adherence and diet tolerability.

• The sample size was 19.
• The two groups of participants were matched on all variables except history of febrile neutropenia.

Two hospitals in New York

Prospective, randomized, controlled pilot study

• Infection was measured with hospital admission data for febrile neutropenia.  
• Localized infection (along with an ANC less than 500 cells/mm³) also was included.  
• Dietary adherence measured by 24-hour diet recall.
• Student t test measured differences between the groups.

No statistically significant differences in infection was found between the two groups.  
Four patients on each arm developed febrile neutropenia.  
Adherence rate was 94% for neutropenic diet and 100% for FDA-approved food safety guidelines.

• Small sample size.  
• Difficulty adhering to the neutropenic diet was reported.  
• Adherence measured by 24-hour diet recall.