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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01687231
First Posted: September 18, 2012
Last Update Posted: May 10, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Duke University
  Purpose
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.

Condition Intervention
Hematologic Malignancies Other: Non-neutropenic Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Pilot Study Comparing Infection Rates in Myeloablative Allogeneic Stem Cell Transplant Patients Receiving a Non-Neutropenic Diet or a Neutropenic Diet

Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Enrollment: 47
Study Start Date: April 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01687231


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Study Chair: Nelson Chao, MD, MBA Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01687231     History of Changes
Other Study ID Numbers: Pro00012374
Pro00012374 ( Other Identifier: DUHS IRB )
First Submitted: September 11, 2012
First Posted: September 18, 2012
Last Update Posted: May 10, 2013
Last Verified: May 2013

Keywords provided by Duke University:
Neutropenic Diet, Non-Neutropenic Diet, Allogeneic SCT