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NCT01164956 · ClinicalTrials.gov registry record · Phase 1
Methylphenidate for Cancer-Related Fatigue
A Phase 1 study, sponsored by Dana-Farber Cancer Institute.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT01164956: Clinical Trial Phase 1 study, sponsored by Dana-Farber Cancer Institute.
NCT01164956 is a Phase 1 study that was terminated before completion, run by Dana-Farber Cancer Institute. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01164956, a Phase 1 study, was terminated before completion, sponsored by Dana-Farber Cancer Institute.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study 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.
Primary Outcome
The feasibility of conducting an N-1-T to evaluate MPH for cancer-related fatigue will be determined by the completion rate of two MPH-placebo pairs.
Interventions
- OTHER Placebo
- DRUG methylphenidate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2011-07 |
| Est. Completion | 2013-03 |
| Phase | Phase 1 |
Why NCT01164956 stopped before completion
NCT01164956 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01164956 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01164956 about?
NCT01164956 is a clinical study titled "Methylphenidate for Cancer-Related Fatigue". 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 onc...
What is the current status of trial NCT01164956?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2011-07. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01164956?
The interventions under investigation include: Placebo (OTHER), methylphenidate (DRUG).
Who is sponsoring clinical trial NCT01164956?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01164956's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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