Clinical trial · Observational
Metabolic Syndrome in Young Patients With Acute Lymphoblastic Leukemia in Remission
The Metabolic Syndrome in Pediatric Acute Lymphoblastic Leukemia (ALL).
NCT00801346CI-TRIAL-00027104completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fatigue | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Long-term Effects Secondary to Cancer Therapy in Children | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| assessment of therapy complications | Procedure | — | UNRESOLVED |
| fatigue assessment and management | Procedure | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| metabolic assessment | Other | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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)
- measure
- Diet as assessed by the Food Frequency Questionnaire at baseline and at 6 and 12 months
- measure
- Family history as assessed by the Family History Questionnaire at baseline
- measure
- 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
- measure
- Physical activity as assessed by the Godlin Leisure Time Activity Questionnaire at baseline and at 6 and 12 months
- measure
- Fatigue as assessed by the Pediatric Quality of Life Multidimensional Fatigue Survey at baseline and at 6 and 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 20 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.