The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients

NCT ID: NCT00726934

Last Updated: 2017-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2017-01-31

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.

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 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Neutropenic Diet

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.

Group Type: ACTIVE_COMPARATOR

Food Safety Guidelines

Intervention Type: 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.

Neutropenic Diet

Intervention Type: 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

FDA Food Safety Guidelines

Participants will be instructed to follow the FDA Food Safety Guidelines

Group Type: ACTIVE_COMPARATOR

Food Safety Guidelines

Intervention Type: 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.

Interventions

Food Safety Guidelines

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.

Intervention Type: OTHER

Neutropenic Diet

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

Intervention Type: OTHER

Other Intervention Names

Food Safety Diet; FDA Food Safety Guidelines; Low Bacteria Diet

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Karen Moody

Director of Pediatric Palliative Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen Moody, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

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

Countries

United States

Other Identifiers

06-08-367

Identifier Type: -

Identifier Source: org_study_id