The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care
Neutropenic Infection
approximately 4 weeks
Yes
Karen Moody, MD, MS
Principal Investigator
Montefiore Medical Center
United States: Institutional Review Board
06-08-367
NCT00726934
September 2007
December 2013
Name | Location |
---|---|
Maimonides Medical Center | Brooklyn, New York 11219 |
Mount Sinai Medical Center | New York, New York 10029 |
Children's Hospital at Montefiore | Bronx, New York 10467 |
Rady Children's Hospital San Diego | San Diego, California 92123 |
NYU Langone Medical Center | New York, New York 10016 |