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This study has been withdrawn prior to enrollment.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:
Mayo Clinic
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00737191
First received: August 15, 2008
Last updated: March 7, 2012
Last verified: March 2012
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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 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 Analgesics, Opioid Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Serotonin Uptake Inhibitors |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Analgesics Sensory System Agents |
ClinicalTrials.gov processed this record on May 21, 2013