Side effects of methylphenidate in childhood cancer survivors

A randomized placebo-controlled trial

Heather M. Conklin, Joanne Lawford, Bruce W. Jasper, E. Brannon Morris, Scott Howard, Susan W. Ogg, Shengjie Wu, Xiaoping Xiong, Raja B. Khan

Research output: Contribution to journalArticle

32 Citations (Scopus)

Abstract

OBJECTIVES: To investigate the frequency and severity of side effects of methylphenidate among childhood survivors of acute lymphoblastic leukemia and brain tumors and identify predictors of higher adverse effect levels. METHODS: Childhood cancer survivors (N = 103) identified as having attention and learning problems completed a randomized, double-blind, 3-week, home-crossover trial of placebo, low-dose methylphenidate (0.3 mg/kg; 10 mg twice daily maximum) and moderate-dose methylphenidate (0.6 mg/kg; 20 mg twice daily maximum). Caregivers completed the Barkley Side Effects Rating Scale (SERS) at baseline and each week during the medication trial. Siblings of cancer survivors (N = 49) were recruited as a healthy comparison group. RESULTS: There was a significantly higher number and severity of symptoms endorsed on the SERS when patients were taking moderate dose compared with placebo or low dose, but not low dose compared with placebo. The number of side effects endorsed on the SERS was significantly lower during all 3 home-crossover weeks (placebo, low dose, moderate dose) when compared with baseline symptom scores. The severity of side effects was also significantly lower, compared with baseline screening, during placebo and low-dose weeks but not moderate-dose weeks. Both the number and severity of symptoms endorsed at baseline were significantly higher for patients compared with siblings. Female gender and lower IQ were associated with higher adverse effect levels. CONCLUSIONS: Methylphenidate is generally well tolerated by childhood cancer survivors. There is a subgroup at increased risk for side effects that may need to be closely monitored or prescribed a lower medication dose. The seemingly paradoxical findings of increased "side effects" at baseline must be considered when monitoring side effects and designing clinical trials.

Original languageEnglish (US)
Pages (from-to)226-233
Number of pages8
JournalPediatrics
Volume124
Issue number1
DOIs
StatePublished - Jul 1 2009

Fingerprint

Methylphenidate
Survivors
Randomized Controlled Trials
Placebos
Neoplasms
Siblings
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Brain Neoplasms
Cross-Over Studies
Caregivers
Clinical Trials
Learning

All Science Journal Classification (ASJC) codes

  • Pediatrics, Perinatology, and Child Health

Cite this

Conklin, H. M., Lawford, J., Jasper, B. W., Morris, E. B., Howard, S., Ogg, S. W., ... Khan, R. B. (2009). Side effects of methylphenidate in childhood cancer survivors: A randomized placebo-controlled trial. Pediatrics, 124(1), 226-233. https://doi.org/10.1542/peds.2008-1855

Side effects of methylphenidate in childhood cancer survivors : A randomized placebo-controlled trial. / Conklin, Heather M.; Lawford, Joanne; Jasper, Bruce W.; Morris, E. Brannon; Howard, Scott; Ogg, Susan W.; Wu, Shengjie; Xiong, Xiaoping; Khan, Raja B.

In: Pediatrics, Vol. 124, No. 1, 01.07.2009, p. 226-233.

Research output: Contribution to journalArticle

Conklin, HM, Lawford, J, Jasper, BW, Morris, EB, Howard, S, Ogg, SW, Wu, S, Xiong, X & Khan, RB 2009, 'Side effects of methylphenidate in childhood cancer survivors: A randomized placebo-controlled trial', Pediatrics, vol. 124, no. 1, pp. 226-233. https://doi.org/10.1542/peds.2008-1855
Conklin, Heather M. ; Lawford, Joanne ; Jasper, Bruce W. ; Morris, E. Brannon ; Howard, Scott ; Ogg, Susan W. ; Wu, Shengjie ; Xiong, Xiaoping ; Khan, Raja B. / Side effects of methylphenidate in childhood cancer survivors : A randomized placebo-controlled trial. In: Pediatrics. 2009 ; Vol. 124, No. 1. pp. 226-233.
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AB - OBJECTIVES: To investigate the frequency and severity of side effects of methylphenidate among childhood survivors of acute lymphoblastic leukemia and brain tumors and identify predictors of higher adverse effect levels. METHODS: Childhood cancer survivors (N = 103) identified as having attention and learning problems completed a randomized, double-blind, 3-week, home-crossover trial of placebo, low-dose methylphenidate (0.3 mg/kg; 10 mg twice daily maximum) and moderate-dose methylphenidate (0.6 mg/kg; 20 mg twice daily maximum). Caregivers completed the Barkley Side Effects Rating Scale (SERS) at baseline and each week during the medication trial. Siblings of cancer survivors (N = 49) were recruited as a healthy comparison group. RESULTS: There was a significantly higher number and severity of symptoms endorsed on the SERS when patients were taking moderate dose compared with placebo or low dose, but not low dose compared with placebo. The number of side effects endorsed on the SERS was significantly lower during all 3 home-crossover weeks (placebo, low dose, moderate dose) when compared with baseline symptom scores. The severity of side effects was also significantly lower, compared with baseline screening, during placebo and low-dose weeks but not moderate-dose weeks. Both the number and severity of symptoms endorsed at baseline were significantly higher for patients compared with siblings. Female gender and lower IQ were associated with higher adverse effect levels. CONCLUSIONS: Methylphenidate is generally well tolerated by childhood cancer survivors. There is a subgroup at increased risk for side effects that may need to be closely monitored or prescribed a lower medication dose. The seemingly paradoxical findings of increased "side effects" at baseline must be considered when monitoring side effects and designing clinical trials.

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