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

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ClinicalTrials.gov Identifier: NCT02000986
Recruitment Status : Withdrawn (Slow accrual)
First Posted : December 4, 2013
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

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.

Condition or disease Intervention/treatment Phase
Childhood Brain Tumor Childhood Hodgkin Lymphoma Childhood Non-Hodgkin Lymphoma Malignant Childhood Neoplasm Behavioral: Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> Chemotherapy Not Applicable

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  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : July 2015


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02000986


Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Marieka A Helou, MD Massey Cancer Center

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02000986     History of Changes
Other Study ID Numbers: MCC-14062
HM14062 ( Other Identifier: Virginia Commonwealth Unniversity IRB )
First Posted: December 4, 2013    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015

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