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Study of Subcutaneous Olanzapine for Hyperactive or Mixed Delirium


N/A
18 Years
N/A
Not Enrolling
Both
Advanced Cancer

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Trial Information

Study of Subcutaneous Olanzapine for Hyperactive or Mixed Delirium


Olanzapine is a drug designed to control agitation/delirium. Olanzapine has been given by
mouth and as an injection into the muscle, which is painful and can increase a person's
feelings of agitation. In this study, olanzapine will be given under the skin through a
catheter. Researchers hope that this will be less painful and agitating than when injected
into the muscle.

If you are found to be eligible to take part in this study, you will have a catheter
(plastic tube) placed under your skin. This catheter will be used to give you the study
medication. Study drug will be given through the catheter every 8 hours for 9 doses. Each
shot should take about 1 to 2 minutes. You will receive the drug at M.D.Anderson Cancer
Center.

Researchers will use the Richmond Agitation Scale to measure your agitation or sedation
before each injection of olanzapine through the catheter. It should take 5 to 10 minutes to
answer the questions. You will be evaluated for catheter site reaction at the time of
injection, at 30 minutes and 1 hour after the injection, and before all further injections
of study drug. Your blood pressure will be evaluated before and 1 hour after the first two
injections and then once a day while on study.

If your agitation is not controlled, you will receive haloperidol. On the second day of
treatment, researchers will record the amount of haloperidol that you had to use in the
previous 24 hours. If the amount of haloperidol that you used is greater than a certain
amount, your dose of olanzapine will be increased. Even if your dose of olanzapine is
increased, you may still be able to use haloperidol if needed.

On the third day of treatment, researchers will record the amount of haloperidol that you
had to use in the previous 24 hours. If the amount of haloperidol that you used is greater
than a certain amount, your dose of olanzapine will again be increased. As before, if your
dose of olanzapine is increased, you may still be able to use haloperidol if needed. If you
respond to olanzapine after 3 days of treatment, you will be given the option to continue
the drug off-study.

If you develop severe side effects before you have completed the 9 doses, treatment will be
stopped. If treatment on this study is stopped, then you will consult with your doctor
about receiving a different medication off study to help control your symptoms. There is no
long-term follow-up for this study.

This is an investigational study. Olanzapine has been FDA approved given into the muscle or
by mouth for the treatment of agitation related to schizophrenia and bipolar mania (a
disorder involving mood swings from deep depression to feelings of elation). A total of 25
patients will take part in this study. All will be enrolled at M.D. Anderson.


Inclusion Criteria:



1. Hospitalized patients on the Acute Palliative Care Unit (G12NW) at the University of
Texas MD Anderson Cancer Center

2. Age > 18 years of age (Olanzapine IM has not been evaluated in pediatric patients.)

3. Patients must have an acceptable surrogate capable of giving consent on the subject's
behalf.

4. Richmond Agitation-Sedation Score (RASS) of >/= 1

5. Mini Mental Status Exam score of less than 24

6. Hyperactive or mixed delirium not responsive to at least 10 mg of haloperidol within
the last 24 hours

Exclusion Criteria:

1. Known hypersensitivity to any ingredient of olanzapine IM

2. The following reactions to haloperidol: A) Acute dystonia B) Hypersensitivity or
previous intolerance to haloperidol C) Extra pyramidal side effects

3. History of narrow-angle glaucoma.

4. Systolic blood pressure < 90 mm Hg

5. If they received an injectable depot neuroleptic within less than one dosing interval
of study initiation

6. Within 7 days of starting study drug, documentation of: a. Fasting blood glucose (or
finger stick glucose check) > 250 mg/dl b. Absolute neutrophil count of < 500 or
platelets < 50,000

7. The use of any benzodiazepines or neuroleptic medications, besides haloperidol, while
the patient is enrolled on study, is prohibited.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Participant Toxicity

Outcome Description:

Toxicity defined as urticaria, injection site reactions, and/or hypotension. At time 0, 0.5, and 1 hour after the first injection of study drug and prior to all subsequent injections of study drug, urticaria and injection site reaction assessed using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 3.0. Blood pressure evaluated immediately before and 1 hour after each of the first 2 injections, and then daily thereafter.

Outcome Time Frame:

Within 75 hours of the initial treatment

Safety Issue:

Yes

Principal Investigator

Ahmed Elsayem, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2004-0746

NCT ID:

NCT00512291

Start Date:

June 2005

Completion Date:

August 2009

Related Keywords:

  • Advanced Cancer
  • Advanced Cancer
  • Hyperactive Delirium
  • Mixed Delirium
  • Olanzapine
  • Delirium
  • Hyperkinesis
  • Neoplasms

Name

Location

U.T.M.D. Anderson Cancer CenterHouston, Texas  77030