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Short-Term Efficacy of Methylphenidate: A Randomized, Double-Blind, Placebo-Controlled Trial Among Survivors of Childhood Cancer

From the Division of Behavioral Medicine, Division of Neurology, Department of Hematology/Oncology, Department of Biostatistics, Pharmaceutical Department, and Department of Radiological Sciences, St Jude Children’s Research Hospital, Memphis, TN; Department of Pediatrics, Medical University of South Carolina, Charleston, SC; and Department of Psychiatry and Behavioral Sciences, and Brain Tumor Center at Duke University Medical Center, Durham, NC. Dr Brown is currently at the College of Health Professions, Temple University, Philadelphia, PA.

Address reprint requests to Raymond K. Mulhern, PhD, Division of Behavioral Medicine, St Jude Children’s Research Hospital, 332 N Lauderdale, Memphis, TN 38105-2794; e-mail: raymond.mulhern{at}stjude.org

PURPOSE: Children surviving acute lymphoblastic leukemia (ALL) and malignant brain tumors (BTs) have a higher incidence of attention and learning problems in school than do their healthy peers. The present study tests the hypothesis that the psychostimulant methylphenidate (MPH) improves cognitive and social functioning among these patients.

PATIENTS AND METHODS: We report on 83 long-term survivors of ALL and BT identified as having attentional deficits on behavioral testing and parent or teacher report, and problems with academic achievement. The 47 male and 36 female patients ranged from 0.6 to 14.3 years (median, 5.4 years) of age at diagnosis and 6.7 to 17.9 years (median, 11.9 years) of age at participation. The patients (40 ALL, 43 BT) participated in a randomized, double-blind, 3-week home cross-over trial of placebo (bid), low-dose MPH (0.3 mg/kg; maximum dose, 10 mg bid), and moderate-dose MPH (0.6 mg/kg; maximum dose, 20 mg bid). The primary end points were weekly teacher and parent reports on the Conners’ Rating Scales and Social Skills Rating System.

RESULTS: Compared to placebo, significant improvement with MPH was reported by teachers and parents on the Conners’ Rating Scales and by teachers on the Social Skills Rating System. However, no consistent advantage of moderate dose over low dose was observed. Of those participating, 66 (79.5%) of the 83 patients continued on best clinical management.

CONCLUSION: Treatment with MPH can at least temporarily reduce some attentional and social deficits among survivors of childhood ALL and BT. Long-term follow-up will reveal those subsets of patients who are more likely to benefit from MPH.

Supported in part by Cancer Center Support (CORE) Grant P30 CA21765, R01 CA78957 (R.K.M.), U01 CA81445 from the National Cancer Institute, and by the American Lebanese Syrian Associated Charities.

Portions of this study have been presented at the 40th Annual Meeting of the American Society of Clinical Oncology, New Orleans, LA, June 5-8, 2004; 11th International Symposium on Pediatric Neuro-Oncology, Boston, MA, June 13-16, 2004; and Cancer Survivorship: Pathways to Health After Treatment, Washington, DC, June 16-18, 2004.

Authors’ disclosures of potential conflicts of interest are found at the end of this article.

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