NCT00726934

The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 1 Year – 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Lymphoblastic Leukemia
• Acute Myelogenous Leukemia
• Non-Hodgkins Lymphoma
• Sarcoma
• Neuroblastoma

Interventions

Type	Name	Description
OTHER	Food Safety Guidelines	Participants will be randomized to the food safety guidelines will receive information and recommendations regarding Food Shopping, Food Storage, Food Preparation, Safe Cooking, and Safe Serving of Food.
OTHER	Neutropenic Diet	The Neutropenic Diet Guideline includes all information contained in the FDA Food Safety Guidelines with the addition of the following recommendations: 1. Avoid raw vegetables and fruit (Oranges and bananas are okay.) 2. Avoid take-out foods and fast foods and fountain drinks. 3. Avoid aged cheese (blue, Roquefort, Brie). 4. Cook all produce to well done. Eggs must be hard-boiled. 5. Avoid deli meats. 6. No raw nuts, nuts roasted in shell, or freshly ground nut butters from a health food store. 7. No well water 8. No yogurt

Timeline

• Start date: 2007-09-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2008-08-01
• Last updated: 2017-02-08

Locations

6 sites across 1 country: United States