Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been withdrawn prior to enrollment.
(Slow accrual)
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT02000986
First received: November 26, 2013
Last updated: November 19, 2015
Last verified: November 2015
  Purpose
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 Intervention
Childhood Brain Tumor
Childhood Hodgkin Lymphoma
Childhood Non-Hodgkin Lymphoma
Malignant Childhood Neoplasm
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:
  • Feasibility determined by average attendance and retention [ Time Frame: At 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    Will be assessed via paired T test.

  • Acceptability level at time of enrollment [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    Acceptability will be determined by responses on feedback measures and qualitative analysis of exit interviews.


Enrollment: 0
Study Start Date: August 2012
Study Completion Date: July 2015
Primary Completion Date: March 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:

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.

  Eligibility

Ages Eligible for Study:   11 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
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
  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

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

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: November 19, 2015
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:
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

ClinicalTrials.gov processed this record on September 28, 2016