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NCT Number: NCT01687231

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

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Age 20-70 years of age
  • Karnofsky Performance Scale KPS> 80
  • Ability to read and write English

Exclusion criteria

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

Treatment and study plan

Non-neutropenic Diet

Other

Non-neutropenic diet is without restriction.

Primary outcomes

  1. Incidence of Bacteremia

    Time frame: Duration of hospitalization or neutropenia, an expected average of 5 weeks.

    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.

Secondary outcomes

  1. Assess nutritional status using PG-SGA

    Time frame: Duration of hospitalization or neutropenia, an expected average of 5 weeks.

    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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 18, 2012
Registry last updated
May 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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