CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 469 enrolled
Drug / intervention
Methylphenidatedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00576472
NCT00576472Phase 4Completed

Learning Impairments Among Survivors of Childhood Cancer

St. Jude Children's Research Hospital·interventional·Posted Dec 19, 2007·Updated May 30, 2017

In Brief

A Phase 4 clinical trial evaluating Methylphenidate for Acute Lymphoblastic Leukemia and Brain Tumors. Completed, enrolled 469 participants across 3 sites.

Detailed Summary

Children surviving some types of cancer have a higher risk of developing learning problems after cancer treatment than do children who have not had cancer or its treatment. Cancer treatment may cause problems with learning, attention, and memory. The purpose of this study is to identify brain changes that may underlie learning problems in cancer survivors and investigate whether methylphenidate (a stimulant medication) may reduce these problems. Subjects who have had treatment for acute lymphoblastic leukemia (ALL) or a brain tumor will be asked to take part in this research study. Siblings of some subjects will also be asked to take part, so that their results can be compared with those of children who have had cancer treatment. We hypothesize that children receiving more aggressive therapy will have lower white matter brain volumes and these volumes will be significantly lower than age-matched siblings. We also hypothesize that children who take methylphenidate will show improvements on teacher and parent report measures of attention and social skills.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 19, 2007
Enrollment StartJan 1, 2000
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 10.2 yearsPosted 18.5 years ago

Interventions

Methylphenidatedrug

Please see detailed description for dosing information and study design.