The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00726934
Recruitment Status : Completed
First Posted : August 1, 2008
Last Update Posted : February 8, 2017
Information provided by (Responsible Party):
Karen Moody, Indiana University

July 30, 2008
August 1, 2008
February 8, 2017
September 2007
January 2017   (Final data collection date for primary outcome measure)
Neutropenic Infection [ Time Frame: approximately 4 weeks ]
Same as current
Complete list of historical versions of study NCT00726934 on Archive Site
  • Documented Infection [ Time Frame: approximately 4 weeks ]
  • Quality of life [ Time Frame: Baseline and at study end ]
Same as current
Not Provided
Not Provided
The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients
The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients
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.
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.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
  • Acute Lymphoblastic Leukemia
  • Acute Myelogenous Leukemia
  • Non-Hodgkins Lymphoma
  • Sarcoma
  • Neuroblastoma
  • 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 Name: Low Bacteria Diet
  • 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
    • Other: Neutropenic Diet
  • Active Comparator: FDA Food Safety Guidelines
    Participants will be instructed to follow the FDA Food Safety Guidelines
    Intervention: Other: Food Safety Guidelines
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2017
January 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
1 Year to 30 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Karen Moody, Indiana University
Indiana University
Not Provided
Principal Investigator: Karen Moody, MD, MS Indiana University
Indiana University
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP