Effect of Ketamine on Fatigue Following Cancer Therapy

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.

Conditions

• Cancer
• Fatigue
• Ketamine

Interventions

DRUG

Ketamine

Single intravenous dose

DRUG

Placebo (saline)

Given intravenously over 40 minutes

DRUG

Ketamine

Single intravenous dose given over 40 minutes

DRUG

Midazolam

Given intravenously over 40 minutes

DRUG

Midazolam(placebo)

Given intravenously over 40 minutes

Sponsors & Collaborators

• National Institute of Nursing Research (NINR)

  lead NIH

Principal Investigators

• Leorey N Saligan, C.R.N.P. · National Institute of Nursing Research (NINR)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-12-13

Primary Completion

2019-03-18

Completion

2019-03-18

Countries

• United States

Study Locations