Opioids With or Without Olanzapine in Treating Patients With Moderate to Severe Cancer Pain
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|ClinicalTrials.gov Identifier: NCT00737191|
Recruitment Status : Withdrawn (No accrual; No patients enrolled)
First Posted : August 18, 2008
Last Update Posted : March 9, 2012
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 or disease||Intervention/treatment||Phase|
|Hematopoietic/Lymphoid Cancer Pain Unspecified Adult Solid Tumor, Protocol Specific||Drug: olanzapine Other: placebo||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Primary Purpose:||Supportive Care|
|Official Title:||Analgesic Effect of Olanzapine in Cancer Pain: A Double-Blind Randomized Placebo-Controlled Parallel Group Pilot Study|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||November 2009|
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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00737191
|Study Chair:||Eric E. Prommer, MD||Mayo Clinic|