Ketamine Clinical Trials
Effect of Ketamine on Fatigue Following Cancer Therapy
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Organisation Name: National Institutes of Health Clinical Center (CC)
Overal Status: Terminated
Start Date: December 13, 2014
Last Update: March 20, 2019
Lead Sponsor: National Institute of Nursing Research (NINR)
Brief Summary: Background:Conditions
- 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.
- To better understand fatigue in people who completed radiation therapy for cancer. To look at the effects of a dose of ketamine on fatigue.
- Adults 18 and older who completed radiation therapy for cancer and are enrolled in NIH protocol 08-NR-0132.
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.
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