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

NCT01687231 | Completed DMC

• 1 other identifier: Pro00012374
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hematologic Malignancies

Keywords

Neutropenic Diet, Non-Neutropenic Diet, Allogeneic SCT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assess nutritional status using PG-SGA

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

Study Arms (2)

Neutropenic Diet

NO INTERVENTION

This arm is the control and subjects will receive the standard of care neutropenic diet.

Non-neutropenic Diet

EXPERIMENTAL

This arm is interventional and subjects will receive a non-neutropenic diet without restriction.

Other: Non-neutropenic Diet

Interventions

Non-neutropenic Diet OTHER

Non-neutropenic diet is without restriction.

Non-neutropenic Diet

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Nelson Chao, MD, MBA

  Duke University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: September 18, 2012
• Study Start: April 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 10, 2013

Record last verified: 2013-05

Locations

US (1)