Pain Clinical Trial
Official title:
Analgesic Effect of Olanzapine in Cancer Pain: A Double-Blind Randomized Placebo-Controlled Parallel Group Pilot Study
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.
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.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
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