The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients

Completed · Not applicable

Conditions studied: Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Non-Hodgkins Lymphoma, Sarcoma, Neuroblastoma

In brief

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.

Key facts

Study ID

NCT00726934

Run by

Indiana University

People needed

149

Starts

2007-09-01

Expected to finish

2017-01-01

Last updated by the study team

2017-02-08

Who can join

Age: 1 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Rady Children's Hospital San Diego — San Diego, California, United States
• Riley Hospital for Children at IU Health — Indianapolis, Indiana, United States
• Maimonides Medical Center — Brooklyn, New York, United States
• NYU Langone Medical Center — New York, New York, United States
• Mount Sinai Medical Center — New York, New York, United States
• Children's Hospital at Montefiore — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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