Infection Rates of Myeloablative Allo SCT Recipients Receiving Neutropenic Diets Versus Non-Neutropenic Diets

A Randomized Pilot Study Comparing Infection Rates in Myeloablative Allogeneic Stem Cell Transplant Patients Receiving a Non-Neutropenic Diet or a Neutropenic Diet

In the transplant community, there is debate regarding the most appropriate food services for stem cell transplant patients. Recommendations regarding the use of low bacterial diets have been based on theoretical concepts of reducing the risk of contracting infections from pathogens found in food sources rather than clinical trials. The evidence for the use of a neutropenic diet is weak. To date, there have been little to no randomized controlled studies addressing the question whether a neutropenic diet in addition to prophylactic antibiotics is necessary as infection prevention in myeloablative stem cell transplant patients. For this reason, our research is aimed at providing data to substantiate the use of neutropenic diets in preventing infections in recipients of myeloablative stem cell transplants.

Study Overview

• Status: Completed
• Conditions: Hematologic Malignancies
• Intervention / Treatment: Other: Non-neutropenic Diet

Detailed Description

In the proposed pilot study, a randomized design will be used to address the primary and secondary aims. Subjects will be randomized to either the experimental group receiving a non-neutropenic diet without restriction, or to the control group receiving the standard neutropenic diet. While randomization will occur prior to, or on the day of their inpatient admission and the subjects will begin study procedures upon admission to the Adult Stem Cell Transplant Inpatient Unit at Duke University Medical Center.

The diet will continue until 1) the subject is no longer neutropenic, and/or 2) discharged from the inpatient unit to continue their care in the Adult Stem Cell Transplant Outpatient Clinic. By limiting the study to the time of care on the inpatient unit, we will minimize the opportunity for deviation from the assigned diet. Absence of neutropenia will be defined as an absolute neutrophil count of greater than 500/uL (manual differential) and a total white blood cell count of 1000/uL for three consecutive days.

All subjects enrolled will follow the standard prophylactic antibiotic regimen. Other supportive care will also be consistent in the two groups.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Scheduled to undergo a myeloablative allogeneic stem cell transplant for any cancer or non-cancer illness from any related or unrelated donor source including bone marrow, peripheral blood progenitor cell, or umbilical cord blood
2. Age 20-70 years of age
3. Karnofsky Performance Scale KPS> 80
4. Ability to read and write English

Exclusion Criteria:

1. Autologous stem cell transplant recipients
2. Non-myeloablative or reduced intensity stem cell transplant recipients
3. Pregnant women
4. Patients with a documented active infection prior to starting their preparative regimen. This includes grade 3 or higher viral, bacterial, or fungal infection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Neutropenic Diet; This arm is the control and subjects will receive the standard of care neutropenic diet.
Experimental: Non-neutropenic Diet; This arm is interventional and subjects will receive a non-neutropenic diet without restriction.	Other: Non-neutropenic Diet; Non-neutropenic diet is without restriction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Bacteremia	Participants will be followed for the duration of hospital stay or until neutropenic, an expected average of 5 weeks. The time frame will be measured from the date of randomization until the date of discharge from the inpatient unit of the hospital or until they are assessed to be neutropenic, whichever came first, assessed up to 8 weeks.	Duration of hospitalization or neutropenia, an expected average of 5 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess nutritional status using PG-SGA	The participants will be followed for the duration of hospital stay or until neutropenic, an expected average of 5 weeks. The time frame will measured from the date of randomization until the date of discharge from the inpatient unit of the hospital or until they are assessed to be neutropenic, whichever came first, assessed up to 8 weeks. The nutritional status will be assessed by the Scored Patient-Generated Subjective Global Assessment (PG-SGA) platform.	Duration of hospitalization or neutropenia, an expected average of 5 weeks.

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Study Chair: Nelson Chao, MD, MBA, Duke University

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: September 11, 2012
• First Submitted That Met QC Criteria: September 13, 2012
• First Posted (Estimate): September 18, 2012

Study Record Updates

• Last Update Posted (Estimate): May 10, 2013
• Last Update Submitted That Met QC Criteria: May 8, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Neutropenic Diet, Non-Neutropenic Diet, Allogeneic SCT
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: Pro00012374 (Other Identifier: DUHS IRB)