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Study Summary
No. 2008-0369:.......Leukemia......Alison E. Gardner......Leukemia
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Study Summary Title
Study Summary
Number:		2008-0369
Study Title:Are neutropenic diets beneficial to improve outcome?
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Physician New Patient Referral
Name:Alison E. GardnerPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:LeukemiaReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-7090
Contact us about clinical trials
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General Information
Disease Group:LeukemiaSupported By:N/A
Phase of Study:Phase IIReturn
Visit:		 3 x week which is part of their standard follow up treatment after
chemotherapy
Treatment
Agents:		NoneHome Care:not applicable
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		7 days
Description/
Intervention:		The goal of this clinical research study is to compare how 2 types of diets
affect infection in patients with AML, ALL, or MDS who are receiving
chemotherapy. Researchers will also compare how often patients on these 2
diets require intravenous (through a needle in a vein) antibiotics to treat
fever.
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Study Objectives / Outcomes
The purpose of this study is to evaluate the infection rate of leukemia patients who eat two different diets. Patients in the "raw" group will eat cooked food and the addition of raw fruits and vegetables. Patients in the "cooked" group will eat only cooked foods and this is the standard neutropenic diet with no fresh fruits or vegetables allowed. The primary objective of the study is to evaluate the infection rate of leukemia patients who eat two different diets. The secondary objectives will be the incidence of fever requiring intravenous antibitoics in each group and death rate
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Study Status Information
Study Activation / Registration Date:07/23/2009
IRB Review and Approval Date:07/23/2009
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Open
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Newlly diagnosed patients with acute myelogenous leukemia (AML), acute lymphocytic leukemia ( ALL), or myelodysplastic syndrome (MDS) receiving induction chemotherapy or AML, ALL or MDS patients who are in remission receivng consolidation chemotherapy.

2) Patients who will be receiving myelosuppressive chemotherapy for their disease.

3) Patients who will be able to stay in the Houston area for at least 4 weeks

4) Patients who can speak either English or Spanish
Exclusion Criteria:1) Patients who present with an active infection such as pneumonia, bacteremia, urine, c difficele or cellulitis infection

2) Patients who are unable to understand the diet questionnaire which will be written in either English or Spanish

3) Patients who are admitted to the protective environment

4) Patients who are younger than age 18 will not be entered in the study

5) 5. pregnant patients
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Links
Registration Number: NCT00947648
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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