Outpatient Neutropenic Diet Study

This study has been terminated.
(Slow Accrual)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00947648
First received: July 24, 2009
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Leukemia
Neutropenia
Other: Raw Fruits & Vegetables
Other: Cooked Foods
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Are Neutropenic Diets Beneficial to Improve Outcome?

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of Bactermia in Each Participant Group [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Participants evaluated for presence of bacteremia (gram positive, gram negative, and or candidemia). Participants also evaluated for neutropenic fever requiring administration of antibiotics even if the participant does not have a positive blood culture on a weekly basis. At least 2 positive blood cultures are needed for coagulase-negative staphylococci (CoNS) to be considered bacteremia.

  • Infection Rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Episodes of neutropenic fevers requiring IV antibiotics and or hospitalization because many times patients have an infection but there is no positive blood cultures. Evaluation of bacteremia will be done by the two nurse investigators via a data questionnaire weekly, see Appendix E. Patients will require at least 2 positive blood cultures for coag neg staph to be considered bacteremia and if there are any other questionable organisms that could be a contaminant, an infectious disease expert is one of the co-investigators and this person will be consulted if this positive blood culture is considered an infection. If the patient has a fever requiring antibiotics with this positive blood culture, then this will also be considered as to whether this is a true infection.


Enrollment: 30
Study Start Date: July 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
"Raw" Group
Participants will eat cooked food and the addition of raw fruits and vegetables.
Other: Raw Fruits & Vegetables
Diet containing fresh fruits and vegetables in addition to cooked food.
"Cooked" Group
Participants will eat only cooked foods.
Other: Cooked Foods
Diet containing only cooked foods.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00947648

Locations
United States, Texas
U.T. M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Alison E Gardner, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00947648     History of Changes
Other Study ID Numbers: 2008-0369, NCI-2009-01509
Study First Received: July 24, 2009
Last Updated: June 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
acute myelogenous leukemia
AML
myelodysplastic syndrome
MDS
Neutropenia
raw fruits and vegetables

Additional relevant MeSH terms:
Leukemia
Neutropenia
Neoplasms by Histologic Type
Neoplasms
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014