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The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Montefiore Medical Center.
Recruitment status was  Recruiting
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

July 30, 2008
December 29, 2011
September 2007
December 2013   (final data collection date for primary outcome measure)
Neutropenic Infection [ Time Frame: approximately 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00726934 on ClinicalTrials.gov Archive Site
  • 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 ]
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
  • Acute Lymphoblastic Leukemia
  • Acute Myelogenous Leukemia
  • Non-Hodgkins Lymphoma
  • Sarcoma
  • Neuroblastoma
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: Neutropenic Diet
    Participants will be instructed to follow a Neutropenic Diet Guideline.
    Intervention: Other: FDA Food Safety Guidelines
  • Active Comparator: Food Safety Diet
    Participants will be instructed to follow a Food Safety Diet Guideline.
    Intervention: Other: FDA Food Safety Guidelines
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
December 2013
December 2013   (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.
Both
1 Year to 30 Years
No
Contact: Karen Moody, MD, MS 718-741-2342 kmoody@montefiore.org
Contact: Ruth O Santizo, BA 718-741-2342 rsantizo@montefiore.org
United States
 
NCT00726934
06-08-367
Yes
Karen Moody MD, MS, Montefiore Medical Center
Montefiore Medical Center
Not Provided
Principal Investigator: Karen Moody, MD, MS Montefiore Medical Center
Montefiore Medical Center
March 2010

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