Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors

NCT01100658 | Terminated Results DMC

• 2 other identifiers: 2009NTLS0750907M69644
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

While neurocognitive impairments in attention, memory and executive functioning are commonly reported sequelae of childhood leukemia and brain tumors, studies have only recently begun to examine the treatment of attention deficits in this population. Numerous studies have examined the effectiveness of methylphenidate in the treatment of children with attention deficit hyperactivity disorder (ADHD). However, the effectiveness of this medication for improving attention and behavioral functioning in children with medical illnesses or brain injury are less clear. Patients will be randomized to receive one week of Metadate CD (a controlled release form of methylphenidate, similar to Ritalin) and one week of placebo in a double-blind fashion.

Conditions

ALL, Childhood; Leukemia, Lymphoblastic; Leukemia, Lymphoblastic, Acute; Leukemia, Lymphoblastic, Acute, L1; Leukemia, Lymphoblastic, Acute, L2; Leukemia, Lymphoblastic, Acute, Philadelphia-Positive; Leukemia, Lymphocytic, Acute; Leukemia, Lymphocytic, Acute, L1; Leukemia, Lymphocytic, Acute, L2; Lymphoblastic Leukemia; Lymphoblastic Leukemia, Acute; Lymphoblastic Leukemia, Acute, Childhood; Lymphoblastic Leukemia, Acute, L1; Lymphoblastic Leukemia, Acute, L2; Lymphoblastic Lymphoma; Lymphocytic Leukemia, Acute; Lymphocytic Leukemia, L1; Lymphocytic Leukemia, L2; Brain Tumors; Cancer of the Brain; Cancer of Brain; Malignant Primary Brain Tumors; Brain Neoplasms, Malignant

Outcome Measures

Primary Outcomes (1)

• Effectiveness of Methylphenidate on Neurocognitive Components

  Child performance on neuropsychological testing (i.e., using Test of Variables of Attention \[TOVA\] which is a computerized test of attention that assists in the screening, diagnosis, and treatment monitoring of attention disorders, like Attention Deficit Hyperactivity Disorder \[ADHD\], and working memory index of the WisSC IV. Standard scores average = 100 +/- 15. Higher scores indicate better performance. Scores \< or = 1 SD below the mean represent area of deficit.

  Week 1 and Week 2

Secondary Outcomes (1)

• Changes in Parent and Teacher Ratings of Attention, Executive Functioning and Behavior

  Week 1 and Week 2

Study Arms (2)

Methylphenidate

ACTIVE COMPARATOR

Administered 1 capsule each day for 1 week, .3 mg/kg dose.

Drug: Methylphenidate

Placebo

PLACEBO COMPARATOR

Administered 1 capsule each day for 1 week.

Drug: Placebo

Interventions

Methylphenidate DRUG

1 capsule each day for 1 week, .3 mg/kg dose.

Also known as: Metadae CD (TM), Methylphenidate hydrochloride

Methylphenidate

Placebo DRUG

1 capsule per day for 1 week.

Also known as: Inactive substance

Placebo

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Initial Screening and Registration
• Previous diagnosis of acute lymphoblastic leukemia or brain tumor and have been off treatment and in disease-free remission for a minimum of one year; treated at the University of Minnesota Medical Center, Fairview.
• Proficient in English
• Have given informed consent (assent)
• After Initial Screening
• Have evidence of attention impairment based on parent report of attention deficit (\> and = 75% on attention deficit hyperactivity disorder \[ADHD\] Index, Hyperactivity, or Cognitive-Problems/Inattention Index of parent-completed attention deficit hyperactivity disorder (ADHD) rating scale \[Conners Parent Rating Scale\] and perform at least 1.0 standard deviations below the mean on Omissions, Commissions, or Variability indexes of the Test of Variables of Attention (TOVA)
• Have an estimated Full Scale IQ score on the Wechsler Abbreviated Scale of Intelligence (WASI) \>55.

You may not qualify if:

• Have optic pathway gliomas and/or neurofibromatosis
• Diagnosed with ADD/ADHD prior to their cancer diagnosis
• Currently taking antidepressants or antipsychotics
• Currently being treated with stimulant medication
• Blind
• Have glaucoma
• Have a family or personal history of motor or phonic tics or Tourette syndrome
• Have seizures not controlled by antiepileptic drugs
• Taking an MAO-inhibitor
• Have a history of cardiovascular disease, uncontrolled hypertension, or hyperthyroidism, or current hypertension requiring antihypertensives

Sponsors & Collaborators

• University of Minnesota: lead
• Children's Cancer Research Fund: collaborator

Study Sites (1)

University of Minnesota Medical Center, Fairview

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Brain Neoplasms

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Only 1 patient was enrolled in this study, no analysis/outcome data can be reported. This patient completed baseline assessment, but withdrew from the study before beginning the medication trial. No medications/placebo were administered.

Results Point of Contact

• Title: Alicia Kunin-Batson
• Organization: Masonic Cancer Center, University of Minnesota

kunin003@umn.edu

612-624-6931

Study Officials

• Alicia Kunin-Batson, Ph.D.

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2010
• First Posted: April 9, 2010
• Study Start: May 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: March 27, 2015
• Results First Posted: November 22, 2011

Record last verified: 2015-03

Locations

US (1)