Clinical trial · Interventional
The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients
NCT00726934CI-TRIAL-00025849completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
| Non-Hodgkins Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Food Safety Guidelines | Other | — | UNRESOLVED |
| Neutropenic Diet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Neutropenic Diet
- description
- Participants will be instructed to follow a Neutropenic Diet. This group will receive the same information as the Food Safety Arm with some additional recommendations for avoiding high bacteria foods during length of time on study.
- interventionNames
- Other: Food Safety Guidelines
- Other: Neutropenic Diet
- type
- ACTIVE_COMPARATOR
- label
- FDA Food Safety Guidelines
- description
- Participants will be instructed to follow the FDA Food Safety Guidelines
- interventionNames
- Other: Food Safety Guidelines
Primary outcomes (1)
- measure
- Neutropenic Infection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 30 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.