Know Cancer

or
forgot password

The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients


Phase 3
1 Year
30 Years
Open (Enrolling)
Both
Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Non-Hodgkins Lymphoma, Sarcoma, Neuroblastoma

Thank you

Trial Information

The Effectiveness of the Neutropenic Diet in Pediatric Oncology 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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Outcome Measure:

Neutropenic Infection

Outcome Time Frame:

approximately 4 weeks

Safety Issue:

Yes

Principal Investigator

Karen Moody, MD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Montefiore Medical Center

Authority:

United States: Institutional Review Board

Study ID:

06-08-367

NCT ID:

NCT00726934

Start Date:

September 2007

Completion Date:

December 2013

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Acute Myelogenous Leukemia
  • Non-Hodgkins Lymphoma
  • Sarcoma
  • Neuroblastoma
  • Neutropenic Diet
  • Food Safety Guidelines
  • child
  • cancer
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Neuroblastoma
  • Sarcoma

Name

Location

Maimonides Medical CenterBrooklyn, New York  11219
Mount Sinai Medical CenterNew York, New York  10029
Children's Hospital at MontefioreBronx, New York  10467
Rady Children's Hospital San DiegoSan Diego, California  92123
NYU Langone Medical CenterNew York, New York  10016