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The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients

Primary Purpose

Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Non-Hodgkins Lymphoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Food Safety Guidelines
Neutropenic Diet
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Lymphoblastic Leukemia focused on measuring Neutropenic Diet, Food Safety Guidelines, child, cancer

Eligibility Criteria

1 Year - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rady Children's Hospital San Diego
  • Riley Hospital for Children at IU Health
  • Children's Hospital at Montefiore
  • Maimonides Medical Center
  • NYU Langone Medical Center
  • Mount Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Neutropenic Diet

FDA Food Safety Guidelines

Arm 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.

Participants will be instructed to follow the FDA Food Safety Guidelines

Outcomes

Primary Outcome Measures

Neutropenic Infection

Secondary Outcome Measures

Documented Infection
Quality of life

Full Information

First Posted
July 30, 2008
Last Updated
February 7, 2017
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT00726934
Brief Title
The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients
Official Title
The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Non-Hodgkins Lymphoma, Sarcoma, Neuroblastoma
Keywords
Neutropenic Diet, Food Safety Guidelines, child, cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neutropenic Diet
Arm Type
Active Comparator
Arm 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.
Arm Title
FDA Food Safety Guidelines
Arm Type
Active Comparator
Arm Description
Participants will be instructed to follow the FDA Food Safety Guidelines
Intervention Type
Other
Intervention Name(s)
Food Safety Guidelines
Other Intervention Name(s)
Food Safety Diet, FDA Food Safety Guidelines
Intervention Description
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
Intervention Name(s)
Neutropenic Diet
Other Intervention Name(s)
Low Bacteria Diet
Intervention Description
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
Primary Outcome Measure Information:
Title
Neutropenic Infection
Time Frame
approximately 4 weeks
Secondary Outcome Measure Information:
Title
Documented Infection
Time Frame
approximately 4 weeks
Title
Quality of life
Time Frame
Baseline and at study end

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Moody, MD, MS
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rady Children's Hospital San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Riley Hospital for Children at IU Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Children's Hospital at Montefiore
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

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The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients

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