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

November 19, 2015 updated by: Virginia Commonwealth University

Effect of Non-Pharmacologic Interventions on Risk Factors of Cardiovascular Disease in Survivors of Childhood Leukemia, Lymphoma and Brain Tumor

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility determined by average attendance and retention
Time Frame: At 3 months
Acceptability will be determined by responses on feedback measures and qualitative analysis of exit interviews.
At 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility determined by average attendance and retention from the blood pressure at enrollment
Time Frame: At 6 months
Will be assessed via paired T test.
At 6 months
Acceptability level at time of enrollment
Time Frame: At 6 months
Acceptability will be determined by responses on feedback measures and qualitative analysis of exit interviews.
At 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Investigators

  • Principal Investigator: Marieka A Helou, MD, Massey Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

November 26, 2013

First Submitted That Met QC Criteria

November 26, 2013

First Posted (Estimate)

December 4, 2013

Study Record Updates

Last Update Posted (Estimate)

November 20, 2015

Last Update Submitted That Met QC Criteria

November 19, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-14062
  • HM14062 (Other Identifier: Virginia Commonwealth Unniversity IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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