Outpatient Neutropenic Diet Study
|Leukemia Neutropenia||Other: Raw Fruits & Vegetables Other: Cooked Foods||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|Official Title:||Are Neutropenic Diets Beneficial to Improve Outcome?|
- Number of Bactermia in Each Participant Group [ Time Frame: 6 weeks ]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 ]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.
|Study Start Date:||July 2009|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
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.
Participants will eat only cooked foods.
Other: Cooked Foods
Diet containing only cooked foods.
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947648
|United States, Texas|
|U.T. M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Alison E Gardner, PhD||M.D. Anderson Cancer Center|