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Outpatient Neutropenic Diet Study

12 juni 2014 uppdaterad av: M.D. Anderson Cancer Center

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

30

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Texas
      • Houston, Texas, Förenta staterna, 77030
        • U.T. M.D. Anderson Cancer Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: "Raw" Group
Participants will eat cooked food and the addition of raw fruits and vegetables.
Övrig: Raw Fruits & Vegetables
Diet containing fresh fruits and vegetables in addition to cooked food.
Övrig: "Cooked" Group
Participants will eat only cooked foods.
Övrig: Cooked Foods
Diet containing only cooked foods.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Bactermia in Each Participant Group
Tidsram: 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.
6 weeks
Infection Rate
Tidsram: 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.
6 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

M.D. Anderson Cancer Center

Utredare

  • Huvudutredare: Alison E Gardner, PhD, M.D. Anderson Cancer Center

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juli 2009

Primärt slutförande (Faktisk)

1 mars 2013

Avslutad studie (Faktisk)

1 mars 2013

Studieregistreringsdatum

Först inskickad

24 juli 2009

Först inskickad som uppfyllde QC-kriterierna

27 juli 2009

Första postat (Uppskatta)

28 juli 2009

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

13 juni 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 juni 2014

Senast verifierad

1 juni 2014

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2008-0369
  • NCI-2009-01509 (Registeridentifierare: NCI CTRP)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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