Phase 4
N=469
Learning Impairments Among Survivors of Childhood Cancer
Acute Lymphoblastic Leukemia · Brain Tumors
Bottom Line
View on ClinicalTrials.gov: NCT00576472 ↗Enrolled (actual)
469
Serious AEs
0.0%
Results posted
Apr 2012
Primary outcome: Primary: Brain White Matter Volume for Patients Versus Sibling Controls — 27; 30.3 percentage — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Methylphenidate (Drug)
- Age
- Pediatric, Adult · 6+ yrs
- Sex
- All
- Sponsor
- St. Jude Children's Research Hospital
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brain White Matter Volume for Patients Versus Sibling Controls |
27; 30.3 | <.0001 sig |
| PRIMARY Brain White Matter Volume for Patients With Acute Lymphoblastic Leukemia Versus Brain Tumors |
28.4; 25.5 | <.0001 sig |
| PRIMARY Brain White Matter Volume for Treatment Intensity Groups and Sibling Controls |
30.3; 28.8; 25.9; 25.4 | 0.025 sig |
| PRIMARY Change From Methylphenidate (MPH) Home Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Teacher Rating Scale (CTRS: ADHD T Score) |
-7.17 | .0005 sig |
| PRIMARY Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Teacher Rating Scale (CTRS: Cognitive Problem T Score) |
-3.34 | 0.0413 sig |
| PRIMARY Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Parent Rating Scale (CPRS: ADHD T Score) |
-8.74 | <.0001 sig |
| PRIMARY Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conner's Parent Rating Scale (CPRS: Cognitive Problem T Score) |
-9.56 | <.0001 sig |
| PRIMARY Change From Maintenance Phase Baseline to Completion of Phase as Measured by Social Skill Rating System (SSRS-P) |
7.99 | <.0001 sig |
| PRIMARY Change From Maintenance Phase Baseline to Completion of Phase as Measured by Wechsler Individual Achievement Test (WIAT) Reading: Composite Standard Score |
-0.21 | .8425 |
| PRIMARY Change From Maintenance Phase Baseline to Completion of Phase as Measured by Wechsler Individual Achievement Test (WIAT) Spelling: Standard Score |
-2.41 | .0016 sig |
| PRIMARY Change From Maintenance Phase Baseline to Completion of Phase as Measured by Wechsler Individual Achievement Test (WIAT) Math: Composite Standard Score |
0.22 | .8329 |
| SECONDARY Best Weekly Score Measured by Conners' Parent Rating Scale (CPRS: ADHD T Score) During the 3-week Home Crossover Phase. |
49.49; 50.87; 50.44; 55.64; 53.14; 51.72 | — |
| SECONDARY Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners' Parent Rating Scale (CPRS) Cognitive Problem/Inattention Scale. |
57.6595; 54.6491; 52.9854 | 0.0077 sig |
| SECONDARY Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners' Parent Rating Scale (CPRS) Hyperactivity Scale. |
54.2138; 52.2771; 51.5143 | 0.0428 sig |
| SECONDARY Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners' Parent Rating Scale (CPRS) ADHD Index. |
57.5805; 54.4226; 53.5317 | 0.0035 sig |
| SECONDARY Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners' Teacher Rating Scale (CTRS) Cognitive Problem/Inattention Scale. |
62.7053; 59.3272; 59.6638 | 0.0001 sig |
| SECONDARY Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners' Teacher Rating Scale (CTRS) Hyperactivity Scale. |
55.7638; 52.1765; 52.6495 | 0.0002 sig |
| SECONDARY Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners' Teacher Rating Scale (CTRS) ADHD Index. |
58.7691; 54.7438; 54.1974 | 0.0002 sig |
| SECONDARY Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Parent (SSRS-P) - Social Skill. |
99.4412; 101.5457; 101.8999 | 0.1386 |
| SECONDARY Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Parent (SSRS-P) - Problem Behavior. |
97.4890; 97.0891; 97.5709 | 0.7496 |
| SECONDARY Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Teacher (SSRS-T) - Social Skill. |
97.6171; 100.6957; 102.5281 | 0.0190 sig |
| SECONDARY Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Teacher (SSRS-T) - Problem Behavior. |
100.6084; 98.6610; 97.3103 | 0.1202 |
| SECONDARY Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner's Continuous Performance Test (CPT) for Omission Errors. |
1.8889; 1.6269; 0.2620 | 0.7027 |
| SECONDARY Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner's Continuous Performance Test (CPT) for Commission Errors. |
3.6984; 3.5970; 0.1014 | 0.7493 |
| SECONDARY Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner's Continuous Performance Test (CPT) for Hit Reaction Time. |
350.0590; 354.8515; -4.7925 | 0.7339 |
| SECONDARY Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner's Continuous Performance Test (CPT) for d' (Sensitivity). |
1.6809; 1.7972; -0.1163 | 0.6148 |
| SECONDARY Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner's Continuous Performance Test (CPT) for Beta (Risk Taking). |
0.2300; 0.2647; -0.0346 | 0.4456 |
| SECONDARY Establish the Effectiveness of MPH on Laboratory Measures of Learning and Recall Using California Verbal Learning Test (CVLT) Over Five Learning Trials. |
44.6970; 45.9403; -1.2433 | 0.5866 |
| SECONDARY Establish the Effectiveness of MPH on Laboratory Measures of Learning and Recall Using California Verbal Learning Test (CVLT) for Short Delay Free Recall. |
-0.3636; -0.3358; -0.0278 | 0.8918 |
| SECONDARY Establish the Effectiveness of MPH on Laboratory Measures of Learning and Recall Using California Verbal Learning Test (CVLT) for Long Delay Free Recall. |
-0.3692; -0.2090; -0.1603 | 0.4427 |
| SECONDARY Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Word Naming Time. |
39.0156; 37.8571; 1.1585 | 0.4203 |
| SECONDARY Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Color Naming Time. |
40.7031; 39.8889; 0.8142 | 0.5754 |
| SECONDARY Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Ink Color Naming Time. |
45.1094; 41.7937; 3.3157 | 0.0251 sig |
| SECONDARY Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Interference Score. |
52.6875; 50.6349; 2.0526 | 0.1049 |
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.
Eligibility Criteria
Inclusion Criteria
- Age: 6 to 18 years old.
- Active subject at St. Jude Children's Research Hospital, or is an age-matched sibling control subject.
- If a subject, received treatment for brain tumor or ALL with either radiation therapy and/or chemotherapy directed at the brain.
- If a subject, at least 12 months post-completion of antineoplastic therapies
- If a subject, no evidence of malignancy, or continuously stable disease since completion of therapy
- English as a primary language
- Informed consent
Exclusion Criteria
- Glaucoma
- Patient or immediate family member with a history of Tourette's syndrome
- Current antidepressant, anxiolytic, antipsychotic or stimulant therapy
- History of substance abuse
- Recent history of uncontrolled seizures
- Uncorrected hypothyroidism
- Previously or currently randomized on COGRM1 intervention arm
- Previously diagnosed with ADHD, or, if a patient, diagnosed with ADHD prior to diagnosis of malignancy
Data sourced from ClinicalTrials.gov (NCT00576472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.