The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients

February 7, 2017 updated by: Karen Moody, Indiana University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92123
        • Rady Children's Hospital San Diego
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Riley Hospital for Children at IU Health
    • New York
      • Bronx, New York, United States, 10467
        • Children's Hospital at Montefiore
      • Brooklyn, New York, United States, 11219
        • Maimonides Medical Center
      • New York, New York, United States, 10016
        • NYU Langone Medical Center
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 26 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Neutropenic Diet
Participants will be instructed to follow a Neutropenic Diet. This group will receive the same information as the Food Safety Arm with some additional recommendations for avoiding high bacteria foods during length of time on study.
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 Names:
  • Food Safety Diet
  • FDA Food Safety Guidelines
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
Other Names:
  • Low Bacteria Diet
Active Comparator: FDA Food Safety Guidelines
Participants will be instructed to follow the FDA Food Safety Guidelines
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 Names:
  • Food Safety Diet
  • FDA Food Safety Guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neutropenic Infection
Time Frame: approximately 4 weeks
approximately 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Documented Infection
Time Frame: approximately 4 weeks
approximately 4 weeks
Quality of life
Time Frame: Baseline and at study end
Baseline and at study end

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Karen Moody, MD, MS, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

July 30, 2008

First Submitted That Met QC Criteria

July 31, 2008

First Posted (Estimate)

August 1, 2008

Study Record Updates

Last Update Posted (Estimate)

February 8, 2017

Last Update Submitted That Met QC Criteria

February 7, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-08-367

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sarcoma

Clinical Trials on Food Safety Guidelines

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe