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Opioids With or Without Olanzapine in Treating Patients With Moderate to Severe Cancer Pain

This study has been withdrawn prior to enrollment.
(No accrual; No patients enrolled)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00737191
First Posted: August 18, 2008
Last Update Posted: March 9, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic
  Purpose

RATIONALE: Opioids lessen pain caused by cancer. It is not yet known whether opioids are more effective when given together with or without olanzapine in treating cancer pain.

PURPOSE: This randomized clinical trial is studying opioids to see how well they work when given together with or without olanzapine in treating patients with moderate to severe cancer pain.


Condition Intervention
Hematopoietic/Lymphoid Cancer Pain Unspecified Adult Solid Tumor, Protocol Specific Drug: olanzapine Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Supportive Care
Official Title: Analgesic Effect of Olanzapine in Cancer Pain: A Double-Blind Randomized Placebo-Controlled Parallel Group Pilot Study

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Two-point pain improvement from baseline (0-10 numeric pain rating scale)

Secondary Outcome Measures:
  • Comparison of active treatment vs placebo
  • Effect of olanzapine on opiod adverse effects
  • Relationships between endpoints

Enrollment: 0
Study Start Date: August 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Patients receive oral opioid and oral placebo once daily for 4 weeks.
Other: placebo
Given orally
Experimental: Arm II
Patients receive oral opioid and 2.5 mg oral olanzapine once daily for 4 weeks.
Drug: olanzapine
Given orally
Experimental: Arm III
Patients receive oral opioid and 5 mg oral olanzapine once daily for 4 weeks.
Drug: olanzapine
Given orally

Detailed Description:

OBJECTIVES:

  • To assess the analgesic effect of olanzapine when administered in combination with opioids in patients with cancer pain.
  • To assess the opiod-sparing effect of olanzapine vs placebo.
  • To assess the effect of olanzapine on opioid adverse effects.

OUTLINE: Patients undergo opioid titration with a step 3 opioid to maintain a less than 4/10 level of pain (on a 0-10 numeric pain rating scale) to establish a opioid starting dose. When the pain rating increases, patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive oral opioid and oral placebo once daily for 4 weeks.
  • Arm II: Patients receive oral opioid and 2.5 mg oral olanzapine once daily for 4 weeks.
  • Arm III: Patients receive oral opioid and 5 mg oral olanzapine once daily for 4 weeks.

Patients undergo quality of life assessments at baseline and three times weekly by questionnaires using a scale from 0-3 and pain assessments periodically by Brief Pain Inventory, Edmonton Symptom Assessment Scale, Linear Analogue Scale Assessments, and Mini-Mental State Examination.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Moderate to severe cancer pain

    • Pain score ≥ 7/10 (0-10 numeric pain rating scale)
    • Requires strong opioids (step 3) for pain control or are already on stable doses of step 3 opioids
  • Opioid induced cognitive dysfunction or cognitive impairment, defined as cognitive disorder not otherwise specified according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) allowed
  • No nonmalignant pain

    • If patient has both malignant and nonmalignant pain, eligibility will be determined by the predominant site of pain

PATIENT CHARACTERISTICS:

  • Life expectancy ≥ 3 months
  • Normal renal function
  • Not pregnant or nursing
  • Negative pregnancy test
  • Must have a telephone
  • Able to complete patient questionnaires alone or with assistance
  • No delirium
  • No hepatic dysfunction
  • No nursing home patients
  • No intractable nausea or vomiting
  • No true allergy or intolerance to opioids
  • No gastrointestinal pathology that influences absorption of opioids
  • No drug seeking behavior or recent substance abuse history
  • No major depression
  • No respiratory compromise
  • No evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
  • No evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study

PRIOR CONCURRENT THERAPY:

  • More than 1 month since prior radiotherapy, chemotherapy, or radionuclides
  • More than 1 month since prior bisphosphonates
  • No prior surgery that influences absorption of opioids
  • No concurrent therapeutic procedures or treatments that influence pain
  • No concurrent active radiation or antineoplastic therapies
  • No concurrent retroviral therapies
  • No concurrent drugs that interfere with CYP34A, CYP1A2, or CYP2D6
  • No concurrent drugs that interfere with morphine metabolism
  • No concurrent medications that will influence the disposition of morphine or methadone
  • No other concurrent antiemetics, antianxiety, or neuroleptic agents
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00737191


Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Study Chair: Eric E. Prommer, MD Mayo Clinic
  More Information

Responsible Party: Eric E. Prommer, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00737191     History of Changes
Other Study ID Numbers: CDR0000588630
P30CA015083 ( U.S. NIH Grant/Contract )
MCS930 ( Other Identifier: Mayo Clinic Cancer Center )
07-007571 ( Other Identifier: Mayo Clinic IRB )
First Submitted: August 15, 2008
First Posted: August 18, 2008
Last Update Posted: March 9, 2012
Last Verified: March 2012

Keywords provided by Mayo Clinic:
unspecified adult solid tumor, protocol specific
hematopoietic/lymphoid cancer
pain

Additional relevant MeSH terms:
Cancer Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents