The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients

Sarcoma Clinical Trial

Official title:

The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00726934
• Other study ID #: 06-08-367
• Status: Completed
• Phase: N/A
• First received: July 30, 2008
• Last updated: February 7, 2017
• Start date: September 2007
• Est. completion date: January 2017

Study information

• Verified date: February 2017
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Acute Myelogenous Leukemia
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Lymphoma, Non-Hodgkin
• Neuroblastoma
• Non-Hodgkins Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Sarcoma

Intervention

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.
• Neutropenic Diet
The Neutropenic Diet Guideline includes all information contained in the FDA Food Safety Guidelines with the addition of the following recommendations: Avoid raw vegetables and fruit (Oranges and bananas are okay.) Avoid take-out foods and fast foods and fountain drinks. Avoid aged cheese (blue, Roquefort, Brie). Cook all produce to well done. Eggs must be hard-boiled. Avoid deli meats. No raw nuts, nuts roasted in shell, or freshly ground nut butters from a health food store. No well water No yogurt

Locations

Country	Name	City	State
United States	Children's Hospital at Montefiore	Bronx	New York
United States	Maimonides Medical Center	Brooklyn	New York
United States	Riley Hospital for Children at IU Health	Indianapolis	Indiana
United States	Mount Sinai Medical Center	New York	New York
United States	NYU Langone Medical Center	New York	New York
United States	Rady Children's Hospital San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neutropenic Infection		approximately 4 weeks
Secondary	Documented Infection		approximately 4 weeks
Secondary	Quality of life		Baseline and at study end