View Clinical Trial (Medical Research Study)
The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients
| City: |
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San Diego |
| State: |
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California |
| Zip Code: |
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92123 |
| Conditions: |
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Acute Lymphoblastic Leukemia - Acute Myelogenous Leukemia - Non-Hodgkins Lymphoma - Sarcoma - Neuroblastoma |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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.
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| NCT ID: |
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NCT00726934 |
| Primary Contact: |
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Principal Investigator
Karen Moody, MD, MS
Montefiore Medical Center
Karen Moody, MD, MS
Phone: 718-741-2342
Email: kmoody@montefiore.org
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| Backup Contact: |
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Email: rsantizo@montefiore.org
Ruth O Santizo, BA
Phone: 718-741-2342
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| Location Contact: |
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San Diego, California 92123
United States
Jeanie Spies, CPNP
Phone: 858-576-1700
Email: jspies@rchsd.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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