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Dietary and Exercise Interventions in Preventing Cardiovascular Disease in Younger Survivors of Leukemia, Lymphoma, or Brain Tumors

Primary Purpose

Childhood Brain Tumor, Childhood Hodgkin Lymphoma, Childhood Non-Hodgkin Lymphoma

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> Chemotherapy
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Childhood Brain Tumor focused on measuring Hodgkin's Lymphoma, Brain and Nervous System, Non-Hodgkin's Lymphoma, Leukemia, not otherwise specified

Eligibility Criteria

11 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of pediatric cancer
  • Patients 3 months to 1 year after completion of therapy

Exclusion Criteria:

  • Patients who are already on antihypertensive or insulin or cholesterol lowering medication
  • Patients who have not been evaluated for exercise tolerance and cleared by their physician for participation
  • Inability to understand program instructions due to language barrier or mental disability
  • Unable to participate in the outlined exercise program due to a physical disability

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Specimen Collection/Risk Factor Assessment -> Diet/Exercise ->

    Arm Description

    Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> Chemotherapy

    Outcomes

    Primary Outcome Measures

    Feasibility determined by average attendance and retention
    Acceptability will be determined by responses on feedback measures and qualitative analysis of exit interviews.

    Secondary Outcome Measures

    Feasibility determined by average attendance and retention from the blood pressure at enrollment
    Will be assessed via paired T test.
    Acceptability level at time of enrollment
    Acceptability will be determined by responses on feedback measures and qualitative analysis of exit interviews.

    Full Information

    First Posted
    November 26, 2013
    Last Updated
    November 19, 2015
    Sponsor
    Virginia Commonwealth University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02000986
    Brief Title
    Dietary and Exercise Interventions in Preventing Cardiovascular Disease in Younger Survivors of Leukemia, Lymphoma, or Brain Tumors
    Official Title
    Effect of Non-Pharmacologic Interventions on Risk Factors of Cardiovascular Disease in Survivors of Childhood Leukemia, Lymphoma and Brain Tumor
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Slow accrual
    Study Start Date
    August 2012 (undefined)
    Primary Completion Date
    March 2015 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Virginia Commonwealth University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This clinical trial studies dietary and exercise interventions in preventing cardiovascular disease in younger survivors of childhood cancer. Eating a healthy diet and exercising regularly may reduce the risk of cardiovascular disease in younger survivors of childhood cancer.
    Detailed Description
    Participants receive personalized exercise plan and prescription tailored to individual needs and current level of activity and fitness, and they also receive 2 one-hour individual exercise training sessions consisting of 20-30 minutes cardiovascular activity and strength training. Participants receive nutritional education consisting of energy balance, appropriate portion sizes, calorie count, and basic nutrition skills such as label reading every 2 weeks for 12 weeks. After completion of study treatment, patients are followed for up to 6 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Childhood Brain Tumor, Childhood Hodgkin Lymphoma, Childhood Non-Hodgkin Lymphoma, Malignant Childhood Neoplasm
    Keywords
    Hodgkin's Lymphoma, Brain and Nervous System, Non-Hodgkin's Lymphoma, Leukemia, not otherwise specified

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Specimen Collection/Risk Factor Assessment -> Diet/Exercise ->
    Arm Type
    Experimental
    Arm Description
    Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> Chemotherapy
    Intervention Type
    Behavioral
    Intervention Name(s)
    Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> Chemotherapy
    Intervention Description
    Participants will be taught by a registered dietician about energy balance and how body weight relates to energy intake and expenditure, although specific calorie prescriptions will not be given. An exercise physiologist will create a personalized exercise plan and prescription which is tailored to his / her needs and current level of activity and fitness
    Primary Outcome Measure Information:
    Title
    Feasibility determined by average attendance and retention
    Description
    Acceptability will be determined by responses on feedback measures and qualitative analysis of exit interviews.
    Time Frame
    At 3 months
    Secondary Outcome Measure Information:
    Title
    Feasibility determined by average attendance and retention from the blood pressure at enrollment
    Description
    Will be assessed via paired T test.
    Time Frame
    At 6 months
    Title
    Acceptability level at time of enrollment
    Description
    Acceptability will be determined by responses on feedback measures and qualitative analysis of exit interviews.
    Time Frame
    At 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    11 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of pediatric cancer Patients 3 months to 1 year after completion of therapy Exclusion Criteria: Patients who are already on antihypertensive or insulin or cholesterol lowering medication Patients who have not been evaluated for exercise tolerance and cleared by their physician for participation Inability to understand program instructions due to language barrier or mental disability Unable to participate in the outlined exercise program due to a physical disability
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marieka A Helou, MD
    Organizational Affiliation
    Massey Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Dietary and Exercise Interventions in Preventing Cardiovascular Disease in Younger Survivors of Leukemia, Lymphoma, or Brain Tumors

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