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NCT02317341 · ClinicalTrials.gov registry record · Early Phase 1
Effect of Ketamine on Fatigue Following Cancer Therapy
A Early Phase 1 study, sponsored by National Institute of Nursing Research (NINR).
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 2
- Enrollment target
NCT02317341: Clinical Trial Early Phase 1 study, sponsored by National Institute of Nursing Research (NINR).
NCT02317341 is a Early Phase 1 study that was terminated before completion, run by National Institute of Nursing Research (NINR). The registered enrollment target is 2 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02317341, a Early Phase 1 study, was terminated before completion, sponsored by National Institute of Nursing Research (NINR).
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
Background: \- Fatigue is a common side effect of cancer and its treatment. No medications can treat this fatigue. Researchers want to see if the drug ketamine can improve fatigue after radiation therapy for cancer. They will compare the effects of ketamine on fatigue to midazolam, a sedative with similar effects. Objectives: \- To better understand fatigue in people who completed radiation therapy for cancer. To look at the effects of a dose of ketamine on fatigue. Eligibility: \- Adults 18 and older who completed radiation therapy for cancer and are enrolled in NIH protocol 08-NR-0132. Design: * Participants will be screened with medical history, physical exam, and blood and urine tests. They will complete questionnaires about their fatigue and take a breath alcohol test. * The study is divided into 2 phases: * During the first phase I visit, participants will have blood taken. They will talk about their fatigue and other symptoms. They will take thinking and handgrip strength tests. Then they will get either ketamine or placebo (midazolam) through an intravenous line, placed by a needle guided by a thin plastic tube into an arm vein. * Participants will have a follow-up phone call within 1 day. * Participants will have phase I visits 3, 7, and 14 days after infusion. For the 3- and 7-day visits, participants will take thinking and handgrip strength tests. They will complete questionnaires, talk about infusion side effects, and have blood taken. For the 14-day visit, they will talk about their fatigue and infusion side effects. They will start phase II that day. * Phase II visits are the same as phase I, except that the 14-day visit is over the phone.
Interventions
- DRUG Ketamine
- DRUG Midazolam
- DRUG Placebo (saline)
- DRUG Midazolam(placebo)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2014-12-13 |
| Est. Completion | 2019-03-18 |
| Phase | Early Phase 1 |
Why NCT02317341 stopped before completion
NCT02317341 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 4 interventions - of which Ketamine is the first listed.
NCT02317341 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02317341 about?
NCT02317341 is a clinical study titled "Effect of Ketamine on Fatigue Following Cancer Therapy". Background: \- Fatigue is a common side effect of cancer and its treatment. No medications can treat this fatigue. Researchers want to see if the drug ketamine can improve fatigue after radiation therapy for cancer. They will compare the effects of ketamine on fatigue to midazolam, a sedative with ...
What is the current status of trial NCT02317341?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 2 participants. The study started on 2014-12-13. Estimated completion is 2019-03-18.
What interventions are being tested in trial NCT02317341?
The interventions under investigation include: Ketamine (DRUG), Midazolam (DRUG), Placebo (saline) (DRUG), Midazolam(placebo) (DRUG).
Who is sponsoring clinical trial NCT02317341?
This trial is sponsored by National Institute of Nursing Research (NINR), which has 46 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02317341's enrollment target sits among peer trials
2 1973rd of 2000 higher than 16 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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