Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors

NCT ID: NCT01100658

Last Updated: 2015-03-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2010-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Methylphenidate

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

Group Type: ACTIVE_COMPARATOR

Methylphenidate

Intervention Type: DRUG

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

Placebo

Administered 1 capsule each day for 1 week.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

1 capsule per day for 1 week.

Interventions

Methylphenidate

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

Intervention Type: DRUG

Placebo

1 capsule per day for 1 week.

Intervention Type: DRUG

Other Intervention Names

Metadae CD (TM); Methylphenidate hydrochloride; Inactive substance

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Cancer Research Fund

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alicia Kunin-Batson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Locations

University of Minnesota Medical Center, Fairview

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

0907M69644

Identifier Type: OTHER

Identifier Source: secondary_id

2009NTLS075

Identifier Type: -

Identifier Source: org_study_id