Clinical trial NCT00726934: The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients
Official title: The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Lymphoblastic Leukemia
Acute Myelogenous Leukemia
Non-Hodgkins Lymphoma
Sarcoma
Neuroblastoma
Keywords: Neutropenic Diet
Food Safety Guidelines
child
cancer
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2008-08-01
Enrollment: 149
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Neutropenic Infection
timeFrame: approximately 4 weeks
Secondary outcomes:
measure: Documented Infection
timeFrame: approximately 4 weeks
measure: Quality of life
timeFrame: Baseline and at study end
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital San Diego
state: California
city: Indianapolis
country: United States
facility: Riley Hospital for Children at IU Health
state: Indiana
city: Bronx
country: United States
facility: Children's Hospital at Montefiore
state: New York
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
Study officials:
affiliation: Indiana University
name: Karen Moody, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: