Outpatient Neutropenic Diet Study



Status:Recruiting
Conditions:Blood Cancer, Hematology, Leukemia
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:July 2009
Contact:Alison E Gardner, PhD
Phone:713-792-7090

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Are Neutropenic Diets Beneficial to Improve Outcome?


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 antibiotics in each group and death rate.


This study is comparing two different diets. The cooked group will be allowed to eat only
cooked food and cooked fruits or vegetables. The raw group will be able to eat cooked food
and the addition of fresh fruits and vegetables. Patients will be monitored for infection
in both groups. There are still certain foods that you are restricted from eating while
receiving chemotherapy and you will be given a list of these restrictions.

Study Groups:

If you agree to take part in this study, you will be randomly assigned (as in the flip of a
coin) to 1 of 2 groups.

Group 1: Raw group: You will be asked to eat at least 1 raw fruit or vegetable every day
you are on study.

Group 2: Cooked group: You will eat only cooked foods while on study. The study doctor
will give you a list of the foods that you are allowed to eat.

Your medical chart will be monitored while you are on study to check how often you need
antibiotics to treat fever. or if you have an infection.

Diet Questionnaire:

You will be asked to fill out a diet questionnaire every week. The questionnaire will have
5 questions about the foods you have been eating. If you have been released from the
hospital, you can return the questionnaire during your scheduled hospital visits,which
typically take place 3 times per week. You will have no additional visits during this study.
The questionnaire should take about 1-2 minutes each time.

Length of Study:

You will be taken off study if your white blood cell count returns to normal. If your white
blood cell counts do not return to normal, the maximum time that you may be on study is 6
weeks.

This is an investigational study. There has not been enough research to prove if raw
fruits and vegetables can increase your risk of infection. Many hospitals allow
neutropenic patients to eat raw fruits and vegetables and other hospitals restrict fresh
fruits and vegetables but, this has not been adequately investigated.

Up to 128 patients will take part in this study. All will be enrolled at M. D. Anderson.

Inclusion Criteria:

1. Newly 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 receiving 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. difficile 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. Pregnant patients.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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mi
from
Houston, TX
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