Opioids With or Without Olanzapine in Treating Patients With Moderate to Severe Cancer Pain
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.
|Hematopoietic/Lymphoid Cancer Pain Unspecified Adult Solid Tumor, Protocol Specific||Drug: olanzapine Other: placebo|
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||Analgesic Effect of Olanzapine in Cancer Pain: A Double-Blind Randomized Placebo-Controlled Parallel Group Pilot Study|
- Two-point pain improvement from baseline (0-10 numeric pain rating scale)
- Comparison of active treatment vs placebo
- Effect of olanzapine on opiod adverse effects
- Relationships between endpoints
|Study Start Date:||August 2008|
|Study Completion Date:||November 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Active Comparator: Arm I
Patients receive oral opioid and oral placebo once daily for 4 weeks.
Experimental: Arm II
Patients receive oral opioid and 2.5 mg oral olanzapine once daily for 4 weeks.
Experimental: Arm III
Patients receive oral opioid and 5 mg oral olanzapine once daily for 4 weeks.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00737191
|Study Chair:||Eric E. Prommer, MD||Mayo Clinic|