Effect of Ketamine on Fatigue Following Cancer Therapy
Status:
Terminated
Trial end date:
2019-03-18
Target enrollment:
Participant gender:
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.