Trial Information

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 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.