Trial record 3 of 78 for:    "Brain tumor childhood"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Virginia Commonwealth University
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT02000986
First received: November 26, 2013
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

This clinical trial studies dietary and exercise interventions in preventing cardiovascular disease in younger survivors of leukemia, lymphoma, or brain tumors. Eating a healthy diet and exercising regularly may reduce the risk in preventing cardiovascular disease in younger survivors of leukemia, lymphoma, or brain tumors.


Condition Intervention
Childhood Brain Tumor
Childhood Hodgkin Lymphoma
Childhood Non-Hodgkin Lymphoma
Leukemia
Behavioral: Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> Chemotherapy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effect of Non-Pharmacologic Interventions on Risk Factors of Cardiovascular Disease in Survivors of Childhood Leukemia, Lymphoma and Brain Tumor

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Change in weight, defined as a decrease in weight by 5-10% from the enrollment weight [ Time Frame: Baseline to up to 6 months ] [ Designated as safety issue: No ]
    Will be assessed via paired T test.


Secondary Outcome Measures:
  • Change in blood pressure, defined as a decrease in systolic blood pressure by 4-8 mmHg from the blood pressure at enrollment [ Time Frame: Baseline to up to 60 months ] [ Designated as safety issue: No ]
    Will be assessed via paired T test.

  • Change in total cholesterol, defined as a decrease in total cholesterol by 5-7% from the level at time of enrollment [ Time Frame: Baseline to up to months ] [ Designated as safety issue: No ]
    Will be assessed via paired T test.


Estimated Enrollment: 57
Study Start Date: August 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Specimen Collection/Risk Factor Assessment -> Diet/Exercise ->
Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> Chemotherapy
Behavioral: Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> Chemotherapy
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

Detailed Description:

To study the effect of lifestyle changes (dietary and physical activity) on cardiovascular risk factors (BMI, Waist circumference and blood pressure) in childhood survivors of leukemia, lymphoma and brain tumors 2. To study whether there is a difference between the response to intervention between the different types of cancers (leukemia vs. lymphoma vs. brain tumors), and to correlate response to disease 3. To determine the feasibility of lifestyle changes in this patient population 4. To assess adherence to changes in dietary and physical activity during the course of this planned intervention.

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Diagnosis of leukemia, lymphoma, brain tumors
  • 2. At risk and medium risk patient
  • 3. Patients 3 months to 2 year after completion of therapy

Exclusion Criteria:

  • 1. Patients who are already on antihypertensive or insulin or cholesterol lowering medication.
  • 2. High risk patient, as they will receive pharmaceutical intervention
  • 3. Other cancer diagnoses
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02000986

Contacts
Contact: Marieka A Helou, MD 804-828-9605 mhelou@mcvh-vcu.edu

Locations
United States, Virginia
Virginia Commonwealth University, Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Marieka A Helou, MD    804-828-9605    mhelou@vcvh-vcu.edu   
Principal Investigator: Marieka A Helou, MD         
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Marieka A Helou, MD Massey Cancer Center
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02000986     History of Changes
Other Study ID Numbers: MCC-14062, HM14062
Study First Received: November 26, 2013
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
Hodgkin's Lymphoma
Brain and Nervous System
Non-Hodgkin's Lymphoma
Leukemia, not otherwise specified

Additional relevant MeSH terms:
Brain Neoplasms
Cardiovascular Diseases
Hodgkin Disease
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 20, 2014