Effect of Ketamine on Fatigue Following Cancer Therapy
Stopped early · Early Phase 1 · Has a placebo group
Conditions studied: Cancer, Fatigue, Ketamine
In brief
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.
Key facts
- Study ID
- NCT02317341
- Run by
- National Institute of Nursing Research (NINR)
- People needed
- 2
- Starts
- 2014-12-13
- Expected to finish
- 2019-03-18
- Last updated by the study team
- 2019-03-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Progressive or unstable disease other than cancer of any body system causing clinically significant fatigue (e.g. class IV congestive heart failure, end-stage renal disease, liver failure, stage IV chronic obstructive pulmonary disease) including patients with systemic infections (e.g., human immunodeficiency virus (HIV), active hepatitis); and those with chronic inflammatory disease (e.g. rheumatoid arthritis, systemic lupus erythematosus);
- Uncontrolled hypertension and those with left ventricular dysfunction;
- Current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the Diagnostic and Statistical Manual (DSM-IV);
- Subjects with a history of DSM-IV drug or alcohol dependency or abuse (except for caffeine or nicotine dependence) within the preceding 3 months. In addition, subjects who currently are using illicit drugs (except for caffeine or nicotine) must not have used illicit substances in the 2 weeks prior to screen and must have a negative alcohol and drug (except for prescribed benzodiazepines) breathalyzer and urine test at screening, respectively;
- Subjects with clinical hypothyroidism or hyperthyroidism;
- Subjects with one or more seizures, hallucinations, disorientation without a clear and resolved etiology;
- Subjects with traumatic brain injury and/or post-traumatic stress disorder;
- Treatment with a reversible monoamine oxidase inhibitor (MAOI) within two weeks prior to study drug administration;
- Treatment with fluoxetine within five weeks or aripiprazole within three weeks before study drug administration;
- Treatment with any other concomitant medication known to interact with ketamine 14 days prior to study drug administration.
- Received total body irradiation or cranial irradiation for cancer;
- Pregnant or lactating women.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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