Status:
WITHDRAWN
Opioids With or Without Olanzapine in Treating Patients With Moderate to Severe Cancer Pain
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Hematopoietic/Lymphoid Cancer
Pain
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 randomize...
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. *...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00737191
Start Date
August 1 2008
End Date
November 1 2009
Last Update
March 9 2012
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