drugset / Trial / NCT01164956

Methylphenidate for Cancer-Related Fatigue

NCT01164956

RandomizedParallel-groupQuadruple-blindSupportive care

Summary

The overall aim of this pilot study is to conduct a combined N-of-1 trial (N-1-T) of MPH (methylphenidate) for amelioration of fatigue in children with cancer, and to evaluate the N-1-T design both for individual clinical decision making and for clinical trials in symptom management in pediatric oncology patients. Because no one knows which of the study options are best, participants will receive liquid MPH on some days and a placebo on other days. We will compare how the participant feels on MPH days with how they feel on placebo days to determine whether MPH makes a difference.

Timeline

Start
2011-07
Primary completion
2013-03
Completion
2013-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylphenidate Small molecule 0.3 mg/kg Oral
Subject Methylphenidate Small molecule 0.5 mg/kg Oral
Subject Methylphenidate Small molecule 12.5 mg Oral

Indications