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Study Summary
No. 2010-0654:.......Pediatrics......Joya Chandra...... Pediatrics
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Study Summary Title
Study Summary
Number:		2010-0654
Study Title:Nutrition intervention for pediatric patients with acute lymphoblastic leukemia (ALL) treated with prednisone and/or dexamethasone
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Physician New Patient Referral
Name:Joya ChandraPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept: PediatricsReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-3813
Contact us about clinical trials
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General Information
Disease Group:PediatricsSupported By:N/A
Phase of Study:N/AReturn
Visit:
Treatment
Agents:		Behavioral interventionHome Care:
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
Description/
Intervention:		The goal of this research study is to learn if nutrition intervention can help
prevent rapid excess weight gain in pediatric patients with ALL who are
receiving prednisone and/or dexamethasone.
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Study Objectives / Outcomes
        Primary Objective:
        To evaluate if a year long nutrition intervention will prevent an increase in waist circumference from baseline measurements for children/adolescents diagnosed with acute lymphoblastic leukemia (ALL) and being treated with prednisone and/or dexamethasone.

        Secondary Objectives:
        To determine if a year long nutrition intervention will prevent an increase in BMI from baseline measurements for children/adolescents diagnosed with ALL and being treated with prednisone and/or dexamethasone.

        To determine if a year long nutrition intervention will help maintain or decrease triglyceride and cholesterol levels, prevent abnormal values of hemoglobin A1C and improve absolute lymphocyte counts (ALC) from baseline measurements for pediatric ALL patients, receiving prednisone and/or dexamethasone therapy.

        To evaluate caloric intake, nutritional parameters and oxidative stress in pediatric ALL patients receiving prednisone and/or dexamethasone therapy.
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    Study Status Information
    Study Activation / Registration Date:
    IRB Review and Approval Date:05/12/2011
    Study Type:Behavioral
    Recruitment Status:Open
    Projected Accrual:N/A
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    Enrollment Eligibility
    If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
    Inclusion Criteria:1) Acute lymphoblastic leukemia (ALL) patient at MD Anderson Children's Cancer Hospital

    2) Patients receiving prednisone and/or dexamethasone therapy at MD Anderson Children's Cancer Hospital.

    3) Children/adolescents ages 7-18
    Exclusion Criteria:1) Patients receiving nutrition counseling or weight management counseling elsewhere

    2) Pediatric patients who are already receiving steroids that are not part of treatment

    3) History of psychological disorders as indicated in the medical record (eg: eating disorders, depression)
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    Links
    Registration Number: Not Applicable Clinical Trial
    Other Links:
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    Results

    Return to Clinical Trials at M.D. Anderson Cancer Center