Status:
COMPLETED
The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients
Lead Sponsor:
Indiana University
Conditions:
Acute Lymphoblastic Leukemia
Acute Myelogenous Leukemia
Eligibility:
All Genders
1-30 years
Phase:
NA
Brief Summary
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 neut...
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 int...
Eligibility Criteria
Inclusion
- 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
- 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
- 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.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT00726934
Start Date
September 1 2007
End Date
January 1 2017
Last Update
February 8 2017
Active Locations (6)
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1
Rady Children's Hospital San Diego
San Diego, California, United States, 92123
2
Riley Hospital for Children at IU Health
Indianapolis, Indiana, United States, 46202
3
Maimonides Medical Center
Brooklyn, New York, United States, 11219
4
NYU Langone Medical Center
New York, New York, United States, 10016