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The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients

This study is currently recruiting participants.
Verified March 2010 by Montefiore Medical Center
Sponsor:
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00726934
First received: July 30, 2008
Last updated: December 29, 2011
Last verified: March 2010
History of Changes
  Purpose

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 Phase
Acute Lymphoblastic Leukemia
Acute Myelogenous Leukemia
Non-Hodgkins Lymphoma
Sarcoma
Neuroblastoma
 Other: FDA Food Safety Guidelines
 Phase 3

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:

U.S. FDA Resources

Further study details as provided by Montefiore Medical Center:

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: 400
Study Start Date: September 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Neutropenic Diet
Participants will be instructed to follow a Neutropenic Diet Guideline.
 Other: FDA Food Safety Guidelines

Participants will be randomized to one of two dietary guidelines: the neutropenic diet or the food safety guidelines endorsed by the FDA. Both diets include the same guidelines regarding Food Shopping, Food Storage, Food Preparation, Safe Cooking, and Safe Serving of Food. The Neutropenic Diet Guideline includes the following additional 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 nutbutters from a healthfood store.
  7. No well water
  8. No yogurt
Other Names:
  • Neutropenic Diet
  • Food Safety Guidelines
Active Comparator: Food Safety Diet
Participants will be instructed to follow a Food Safety Diet Guideline.
 Other: FDA Food Safety Guidelines

Participants will be randomized to one of two dietary guidelines: the neutropenic diet or the food safety guidelines endorsed by the FDA. Both diets include the same guidelines regarding Food Shopping, Food Storage, Food Preparation, Safe Cooking, and Safe Serving of Food. The Neutropenic Diet Guideline includes the following additional 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 nutbutters from a healthfood store.
  7. No well water
  8. No yogurt
Other Names:
  • Neutropenic Diet
  • 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.

  Eligibility

Ages Eligible for Study:   1 Year to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00726934

Contacts
Contact: Karen Moody, MD, MS 718-741-2342 kmoody@montefiore.org
Contact: Ruth O Santizo, BA 718-741-2342 rsantizo@montefiore.org

Locations
United States, California
Rady Children's Hospital San Diego Recruiting
San Diego, California, United States, 92123
Contact: Jeanie Spies, CPNP     858-576-1700 ext 4347     jspies@rchsd.org    
Contact: Mehrzad Milburn     858-966-8155     mmilburn@rchsd.org    
Principal Investigator: Jeanie Spies, CPNP            
United States, New York
Children's Hospital at Montefiore Recruiting
Bronx, New York, United States, 10467
Contact: Karen Moody, MD, MS     718-741-2342     kmoody@montefiore.org    
Contact: Ruth O Santizo, BA     718-741-2342     rsantizo@montefiore.org    
Principal Investigator: Karen Moody, MD, MS            
Maimonides Medical Center Recruiting
Brooklyn, New York, United States, 11219
Contact: Inan Olmez, MD            
Contact: Jackie Pandolfo, RN     718-765-2677     JPandolfo@maimonides.org    
Principal Investigator: Inan Olmez, MD            
NYU Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Robin Dulman, MD     212-263-8400     robin.dulman@nyumc.org    
Contact: Ruchita Mehta     212-263-9929     Ruchita.Mehta@nyumc.org    
Principal Investigator: Robin Dulman, MD            
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Birte Wistinghausen, MD     212-241-7022     birte.wistinghausen@mssm.edu    
Contact: Nita Narayan     212-241-4142     nita.narayan@mssm.edu    
Principal Investigator: Birte Wistinghausen, MD            
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Karen Moody, MD, MS Montefiore Medical Center
  More Information

No publications provided

Responsible Party: Karen Moody MD, MS, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00726934     History of Changes
Other Study ID Numbers: 06-08-367
Study First Received: July 30, 2008
Last Updated: December 29, 2011
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Montefiore Medical Center:
Neutropenic Diet
Food Safety Guidelines
child
cancer

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Lymphoma
Lymphoma, Non-Hodgkin
Neuroblastoma
Sarcoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Connective and Soft Tissue

ClinicalTrials.gov processed this record on June 18, 2013