Analgesic Effect of Olanzapine in Cancer Pain: A Double-Blind Randomized Placebo-Controlled Parallel Group Pilot Study
18 Years
70 Years
Both
Hematopoietic/Lymphoid Cancer, Pain, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Analgesic Effect of Olanzapine in Cancer Pain: A Double-Blind Randomized Placebo-Controlled Parallel Group Pilot Study
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Outcome Measure:
Two-point pain improvement from baseline (0-10 numeric pain rating scale)
Safety Issue:
No
Principal Investigator
Eric E. Prommer, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000588630
NCT ID:
NCT00737191
Start Date:
August 2008
Completion Date:
November 2009
Related Keywords:
- Hematopoietic/Lymphoid Cancer
- Pain
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- hematopoietic/lymphoid cancer
- pain
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