drugset / Trial / NCT01164956
Methylphenidate for Cancer-Related Fatigue
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |