The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Indiana University
Information provided by (Responsible Party):
Karen Moody, Indiana University Identifier:
First received: July 30, 2008
Last updated: November 13, 2015
Last verified: November 2015
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.

Condition Intervention
Acute Lymphoblastic Leukemia
Acute Myelogenous Leukemia
Non-Hodgkins Lymphoma
Other: Food Safety Guidelines
Other: Neutropenic Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
Official Title: The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients

Resource links provided by NLM:

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Neutropenic Infection [ Time Frame: approximately 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Documented Infection [ Time Frame: approximately 4 weeks ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: Baseline and at study end ] [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: September 2007
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.

Ages Eligible for Study:   1 Year to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00726934

Contact: Karen Moody, MD, MS 3179443478
Contact: Becca A Graffis, MPH 3179443277

United States, California
Rady Children's Hospital San Diego Completed
San Diego, California, United States, 92123
United States, Indiana
Riley Hospital for Children at IU Health Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Karen M Moody, MD MS    317-944-3478   
Contact: Becca A Graffis, MPH    3179443277   
United States, New York
Children's Hospital at Montefiore Completed
Bronx, New York, United States, 10467
Maimonides Medical Center Completed
Brooklyn, New York, United States, 11219
Mount Sinai Medical Center Completed
New York, New York, United States, 10029
NYU Langone Medical Center Completed
New York, New York, United States, 10016
Sponsors and Collaborators
Indiana University
Principal Investigator: Karen Moody, MD, MS Indiana University
  More Information

No publications provided

Responsible Party: Karen Moody, Director of Pediatric Palliative Care, Indiana University Identifier: NCT00726934     History of Changes
Other Study ID Numbers: 06-08-367
Study First Received: July 30, 2008
Last Updated: November 13, 2015
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Indiana University:
Neutropenic Diet
Food Safety Guidelines

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Lymphoma, Non-Hodgkin
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral processed this record on November 27, 2015