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This study has been withdrawn prior to enrollment.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:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00737191
First received: August 15, 2008
Last updated: March 7, 2012
Last verified: March 2012
  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-Blind
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) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of active treatment vs placebo [ Designated as safety issue: No ]
  • Effect of olanzapine on opiod adverse effects [ Designated as safety issue: No ]
  • Relationships between endpoints [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737191

Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Eric E. Prommer, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Eric E. Prommer, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00737191     History of Changes
Other Study ID Numbers: CDR0000588630, P30CA015083, MCS930, 07-007571
Study First Received: August 15, 2008
Last Updated: March 7, 2012
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Olanzapine
Antiemetics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 21, 2014