The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients

Not Applicable

Completed

• Conditions: Acute Lymphoblastic Leukemia; Acute Myelogenous Leukemia; Sarcoma; Non-Hodgkins Lymphoma; Neuroblastoma
• Interventions: Other: Food Safety Guidelines; Other: Neutropenic Diet

• Registration Number: NCT00726934
• Lead Sponsor: Indiana University

Brief Summary

The purpose of this study is to determine if FDA approved food safety guidelines are equivalent to a low bacterial diet (the neutropenic diet) with respect to the acquisition of infections during neutropenia in a sample of pediatric cancer patients.

Detailed Description

Historically, many interventions have been tried to reduce the incidence of infection by reducing patients' exposures to potential pathogens. The neutropenic diet is one such intervention that was intended to reduce the introduction of bacteria into the host's gastrointestinal tract. This diet excludes foods considered to be high risk for bacterial colonization, especially raw fruits and vegetables. The only studies evaluating this diet have used this intervention in combination with germ free environments, which have been phased out of practice, and the independent effect of this diet remains unknown. In addition, pediatric oncology patients suffer significant gastrointestinal side effects secondary to cancer therapy, which are likely to affect their satisfaction with this dietary regimen. Qualitative data in these children suggests that decreased pleasure from food is a major concern for them and preliminary data on the neutropenic diet showed that although patients were able to stick to it, they found it difficult. The Centers for Disease Control (CDC) and the Food and Drug Administration (FDA) offer more liberalized food safety guidelines for immunocompromised patients. We hypothesize that the neutropenic dietary restrictions offer no advantage over the FDA and CDC endorsed food safety guidelines and that the food safety guidelines will afford patients an improved quality of life through increased choice and control over their diet. The results of this study could potentially modify clinical practice to improve the quality of life of these patients without adverse effects on their rate of infection. Furthermore, the allowance of fresh fruits and vegetables back into the diets of these patients may have a positive impact on their health.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-07-30
• Study First Submitted QC: 2008-07-31
• Study First Posted: 2008-08-01
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-07
• Last Update Posted: 2017-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

1. Patients between the ages of 1 and 30 years with:

   • Acute lymphoblastic leukemia/lymphoma
   • Malignant brain tumor
   • Non-CNS solid tumors
   • Acute myeloblastic leukemia
   • Non-Hodgkin's lymphoma Hodgkin's disease
   • Head and Neck tumors

2. Patients MUST also be ready to receive a cycle of chemotherapy that predictably renders neutropenia at least 70% of the time OR has a risk of febrile neutropenia of at least 20%. This can be any cycle number, it does NOT need to be the FIRST cycle of chemotherapy they are to receive.

Exclusion Criteria

• Patients receiving myeloablative chemotherapy in preparation for allogeneic or autologous bone marrow or stem cell transplant.
• Co-morbidity with immunosuppressive disease such as AIDS.
• Asplenia.
• Patients with documented infection at time of enrollment.
• Patients who are not fed orally (G-tube dependant, TPN-dependant).
• Patients actively receiving radiation to the brain or gastrointestinal tract for sarcoma.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neutropenic Diet	Neutropenic Diet	Participants will be instructed to follow a Neutropenic Diet. This group will receive the same information as the Food Safety Arm with some additional recommendations for avoiding high bacteria foods during length of time on study.
Neutropenic Diet	Food Safety Guidelines	Participants will be instructed to follow a Neutropenic Diet. This group will receive the same information as the Food Safety Arm with some additional recommendations for avoiding high bacteria foods during length of time on study.
FDA Food Safety Guidelines	Food Safety Guidelines	Participants will be instructed to follow the FDA Food Safety Guidelines

Primary Outcome Measures

Name	Time	Method
Neutropenic Infection	approximately 4 weeks

Secondary Outcome Measures

Name	Time	Method
Quality of life	Baseline and at study end
Documented Infection	approximately 4 weeks

Trial Locations

Locations (6)

NYU Langone Medical Center; 🇺🇸 New York, New York, United States

Riley Hospital for Children at IU Health; 🇺🇸 Indianapolis, Indiana, United States

Children's Hospital at Montefiore; 🇺🇸 Bronx, New York, United States

Rady Children's Hospital San Diego; 🇺🇸 San Diego, California, United States

Maimonides Medical Center; 🇺🇸 Brooklyn, New York, United States

Mount Sinai Medical Center; 🇺🇸 New York, New York, United States