NCT00947648

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2 leukemia

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2009

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

June 13, 2014

Status Verified

June 1, 2014

Enrollment Period

3.7 years

First QC Date

July 24, 2009

Last Update Submit

June 12, 2014

Conditions

LeukemiaNeutropenia

Keywords

acute myelogenous leukemiaAMLmyelodysplastic syndromeMDSNeutropeniaraw fruits and vegetables

Outcome Measures

Primary Outcomes (2)

  • Number of Bactermia in Each Participant Group

    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

    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

Study Arms (2)

"Raw" Group

OTHER

Participants will eat cooked food and the addition of raw fruits and vegetables.

Other: Raw Fruits & Vegetables

"Cooked" Group

OTHER

Participants will eat only cooked foods.

Other: Cooked Foods

Interventions

Raw Fruits & VegetablesOTHER

Diet containing fresh fruits and vegetables in addition to cooked food.

"Raw" Group
Cooked FoodsOTHER

Diet containing only cooked foods.

"Cooked" Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Patients who will be receiving myelosuppressive chemotherapy for their disease.
  • Patients who will be able to stay in the Houston area for at least 4 weeks.
  • Patients who can speak either English or Spanish.

You may not qualify if:

  • Patients who present with an active infection such as pneumonia, bacteremia, urine, c. difficile or cellulitis infection.
  • Patients who are unable to understand the diet questionnaire which will be written in either English or Spanish.
  • Patients who are admitted to the protective environment.
  • Patients who are younger than age 18 will not be entered in the study.
  • Pregnant patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.T. M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

LeukemiaNeutropeniaLeukemia, Myeloid, AcuteMyelodysplastic Syndromes

Interventions

Vegetables

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesAgranulocytosisLeukopeniaCytopeniaLeukocyte DisordersLeukemia, MyeloidBone Marrow Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Alison E Gardner, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2009

First Posted

July 28, 2009

Study Start

July 1, 2009

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

June 13, 2014

Record last verified: 2014-06

Locations

US(1)