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

NCT ID: NCT02000986

Last Updated: 2015-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-07-31

Brief Summary

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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

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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.

Conditions

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Childhood Brain Tumor Childhood Hodgkin Lymphoma Childhood Non-Hodgkin Lymphoma Malignant Childhood Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marieka A Helou, MD

Role: PRINCIPAL_INVESTIGATOR

Massey Cancer Center

Other Identifiers

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HM14062

Identifier Type: OTHER

Identifier Source: secondary_id

MCC-14062

Identifier Type: -

Identifier Source: org_study_id