The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients

NCT00726934 | Completed DMC

• 1 other identifier: 06-08-367
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 6

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 neutropenia in a sample of pediatric cancer patients.

Conditions

Acute Lymphoblastic Leukemia; Acute Myelogenous Leukemia; Non-Hodgkins Lymphoma; Sarcoma; Neuroblastoma

Keywords

Neutropenic Diet; Food Safety Guidelines; child; cancer

Outcome Measures

Primary Outcomes (1)

• Neutropenic Infection

  approximately 4 weeks

Secondary Outcomes (2)

• Documented Infection

  approximately 4 weeks

• Quality of life

  Baseline and at study end

Study Arms (2)

Neutropenic Diet

ACTIVE COMPARATOR

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.

Other: Food Safety Guidelines; Other: Neutropenic Diet

FDA Food Safety Guidelines

ACTIVE COMPARATOR

Participants will be instructed to follow the FDA Food Safety Guidelines

Other: Food Safety Guidelines

Interventions

Food Safety Guidelines OTHER

Participants will be randomized to the food safety guidelines will receive information and recommendations regarding Food Shopping, Food Storage, Food Preparation, Safe Cooking, and Safe Serving of Food.

Also known as: Food Safety Diet, FDA Food Safety Guidelines

FDA Food Safety Guidelines; Neutropenic Diet

Neutropenic Diet OTHER

The Neutropenic Diet Guideline includes all information contained in the FDA Food Safety Guidelines with the addition of the following recommendations: 1. Avoid raw vegetables and fruit (Oranges and bananas are okay.) 2. Avoid take-out foods and fast foods and fountain drinks. 3. Avoid aged cheese (blue, Roquefort, Brie). 4. Cook all produce to well done. Eggs must be hard-boiled. 5. Avoid deli meats. 6. No raw nuts, nuts roasted in shell, or freshly ground nut butters from a health food store. 7. No well water 8. No yogurt

Also known as: Low Bacteria Diet

Neutropenic Diet

Eligibility Criteria

• Age: 1 Year - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (6)

Rady Children's Hospital San Diego

San Diego, California, 92123, United States

Location

Riley Hospital for Children at IU Health

Indianapolis, Indiana, 46202, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Children's Hospital at Montefiore

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Lymphoma, Non-Hodgkin; Sarcoma; Neuroblastoma; Neoplasms

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid; Lymphoma; Neoplasms, Connective and Soft Tissue; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Karen Moody, MD, MS

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Pediatric Palliative Care

Study Record Dates

• First Submitted: July 30, 2008
• First Posted: August 1, 2008
• Study Start: September 1, 2007
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: February 8, 2017

Record last verified: 2017-02

Locations

US (6)