NCT00801346

Brief Summary

RATIONALE: Gathering information about metabolic syndrome from young patients with acute lymphoblastic leukemia may help doctors learn more about the disease. PURPOSE: This phase I trial is studying the metabolic syndrome in young patients with acute lymphoblastic leukemia in remission.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2008

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2008

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 21, 2017

Status Verified

April 1, 2017

Enrollment Period

7.4 years

First QC Date

December 2, 2008

Last Update Submit

April 20, 2017

Conditions

FatigueLeukemiaLong-term Effects Secondary to Cancer Therapy in Children

Keywords

fatiguelong-term effects secondary to cancer therapy in childrenchildhood acute lymphoblastic leukemia in remissionB-cell childhood acute lymphoblastic leukemiaT-cell childhood acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (1)

  • Development of components of metabolic syndrome as assessed by clinical measures (e.g., body mass index, waist circumference, and blood pressure) and laboratory measures (e.g., fasting lipid profile and fasting insulin and glucose)

Secondary Outcomes (6)

  • Diet as assessed by the Food Frequency Questionnaire at baseline and at 6 and 12 months

  • Family history as assessed by the Family History Questionnaire at baseline

  • Health-related quality of life as assessed by the Pediatric Quality of Life Inventory and the Pediatric Quality of Life Cancer Module at baseline and at 6 and 12 months

  • Physical activity as assessed by the Godlin Leisure Time Activity Questionnaire at baseline and at 6 and 12 months

  • Fatigue as assessed by the Pediatric Quality of Life Multidimensional Fatigue Survey at baseline and at 6 and 12 months

  • +1 more secondary outcomes

Interventions

laboratory biomarker analysisOTHER
metabolic assessmentOTHER
questionnaire administrationOTHER
assessment of therapy complicationsPROCEDURE
fatigue assessment and managementPROCEDURE
quality-of-life assessmentPROCEDURE

Eligibility Criteria

Age1 Year - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: Part 1 * Diagnosis of precursor B-cell acute lymphoblastic leukemia (ALL) * In first remission * In first 3 months of maintenance therapy * No T-cell ALL, very high-risk ALL, or infant ALL (\< 1 year old at diagnosis) Part 2 * Diagnosis of precursor B-cell or T-cell ALL * In first remission * Must have been diagnosed and treated (at least to the maintenance phase) at the Division of Pediatric Oncology at the Vanderbilt-Ingram Cancer Center within the past 7 years * No very high-risk ALL or infant ALL (\< 1 year old at diagnosis) PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior or concurrent cranial radiotherapy (Part 1)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

FatigueLeukemia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Adam J. Esbenshade, MD

    Vanderbilt-Ingram Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 2, 2008

First Posted

December 3, 2008

Study Start

November 1, 2008

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 21, 2017

Record last verified: 2017-04

Locations

US(3)