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

NCT02000986 | Withdrawn DMC

• 2 other identifiers: MCC-14062HM14062
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Hodgkin's Lymphoma; Brain and Nervous System; Non-Hodgkin's Lymphoma; Leukemia, not otherwise specified

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Feasibility determined by average attendance and retention from the blood pressure at enrollment

  At 6 months

• Acceptability level at time of enrollment

  At 6 months

Study Arms (1)

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

EXPERIMENTAL

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

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

Interventions

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

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

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of pediatric cancer
• Patients 3 months to 1 year after completion of therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

MeSH Terms

Conditions

Neoplasms; Hodgkin Disease; Neurologic Manifestations; Lymphoma, Non-Hodgkin; Leukemia

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hematologic Diseases

Study Officials

• Marieka A Helou, MD

  Massey Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 4, 2013
• Study Start: August 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: July 1, 2015
• Last Updated: November 20, 2015

Record last verified: 2015-11