The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients

Sponsor

Indiana University (Other)

Overall Status

Completed

CT.gov ID

NCT00726934

Collaborator

(none)

149

Enrollment

Locations

Arms

112

Duration (Months)

24.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia Acute Myelogenous Leukemia Non-Hodgkins Lymphoma Sarcoma Neuroblastoma	Other: Food Safety Guidelines Other: Neutropenic Diet	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

149 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Supportive Care

Official Title:

The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients

Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Jan 1, 2017

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Other: 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. Other Names: Food Safety Diet FDA Food Safety Guidelines Other: Neutropenic Diet The Neutropenic Diet Guideline includes all information contained in the FDA Food Safety Guidelines with the addition of the following recommendations: Avoid raw vegetables and fruit (Oranges and bananas are okay.) Avoid take-out foods and fast foods and fountain drinks. Avoid aged cheese (blue, Roquefort, Brie). Cook all produce to well done. Eggs must be hard-boiled. Avoid deli meats. No raw nuts, nuts roasted in shell, or freshly ground nut butters from a health food store. No well water No yogurt Other Names: Low Bacteria Diet
Active Comparator: FDA Food Safety Guidelines Participants will be instructed to follow the FDA Food Safety Guidelines	Other: 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. Other Names: Food Safety Diet FDA Food Safety Guidelines

Arm

Intervention/Treatment

Active Comparator: 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.

Other: 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.

Other Names:

Food Safety Diet

FDA Food Safety Guidelines

Other: Neutropenic Diet

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

Other Names:

Low Bacteria Diet

Active Comparator: FDA Food Safety Guidelines

Participants will be instructed to follow the FDA Food Safety Guidelines

Other: Food Safety Guidelines

Other Names:

Food Safety Diet

FDA Food Safety Guidelines

Outcome Measures

Primary Outcome Measures

Neutropenic Infection [approximately 4 weeks]

Secondary Outcome Measures

Documented Infection [approximately 4 weeks]
Quality of life [Baseline and at study end]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rady Children's Hospital San Diego	San Diego	California	United States	92123
2	Riley Hospital for Children at IU Health	Indianapolis	Indiana	United States	46202
3	Children's Hospital at Montefiore	Bronx	New York	United States	10467
4	Maimonides Medical Center	Brooklyn	New York	United States	11219
5	NYU Langone Medical Center	New York	New York	United States	10016
6	Mount Sinai Medical Center	New York	New York	United States	10029