Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors

University of Minnesota (UMN)

Status: Terminated

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

Treatments: Drug: Methylphenidate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01100658

2009NTLS075

0907M69644 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

1 participants in 2 patient groups, including a placebo group

Methylphenidate

Active Comparator group

Description:

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

Treatment:

Drug: Methylphenidate

Placebo

Placebo Comparator group

Description:

Administered 1 capsule each day for 1 week.

Treatment:

Drug: Placebo