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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02317341
The ClinicalTrials.gov registry entry for NCT02317341 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Nursing Research (NINR), which has 46 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Ketamine is the first listed.
NCT02317341 reports 0 study locations.
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.
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