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

Childhood Brain Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02000986
• Other study ID #: MCC-14062
• Secondary ID: HM14062
• Status: Withdrawn
• Phase: N/A
• First received: November 26, 2013
• Last updated: November 19, 2015
• Start date: August 2012
• Est. completion date: July 2015

Study information

• Verified date: November 2015
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 17 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Brain Neoplasms
• Cardiovascular Diseases
• Childhood Brain Tumor
• Childhood Hodgkin Lymphoma
• Childhood Non-Hodgkin Lymphoma
• Hodgkin Disease
• Lymphoma
• Lymphoma, Non-Hodgkin
• Malignant Childhood Neoplasm

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility determined by average attendance and retention	Acceptability will be determined by responses on feedback measures and qualitative analysis of exit interviews.	At 3 months	No
Secondary	Feasibility determined by average attendance and retention from the blood pressure at enrollment	Will be assessed via paired T test.	At 6 months	No
Secondary	Acceptability level at time of enrollment	Acceptability will be determined by responses on feedback measures and qualitative analysis of exit interviews.	At 6 months	No