The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients

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.
Brief Title
The Effectiveness of the Neutropenic Diet in Pediatric Oncology 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.
Completion Date
Completion Date Type
Actual
Conditions
Acute Lymphoblastic Leukemia
Acute Myelogenous Leukemia
Non-Hodgkins Lymphoma
Sarcoma
Neuroblastoma
Eligibility Criteria
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.
Inclusion Criteria
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.

Gender
All
Gender Based
false
Keywords
Neutropenic Diet
Food Safety Guidelines
child
cancer
Healthy Volunteers
No
Last Update Submit Date
Maximum Age
30 Years
Minimum Age
1 Year
NCT Id
NCT00726934
Org Class
Other
Org Full Name
Indiana University
Org Study Id
06-08-367
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients
Primary Outcomes
Outcome Measure
Neutropenic Infection
Outcome Time Frame
approximately 4 weeks
Secondary Outcomes
Outcome Time Frame
approximately 4 weeks
Outcome Measure
Documented Infection
Outcome Time Frame
Baseline and at study end
Outcome Measure
Quality of life
Start Date
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Maximum Age Number (converted to Years and rounded down)
30
Minimum Age Number (converted to Years and rounded down)
1
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jonathan Gill
Investigator Email
jgill@montefiore.org
Investigator Phone
718-741-2331