NCT00737191

Opioids With or Without Olanzapine in Treating Patients With Moderate to Severe Cancer Pain

Analgesic Effect of Olanzapine in Cancer Pain: A Double-Blind Randomized Placebo-Controlled Parallel Group Pilot Study

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 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.

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. * 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.

Conditions

• Hematopoietic/Lymphoid Cancer
• Pain
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	olanzapine	Given orally
OTHER	placebo	Given orally

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2008-08-18
• Last updated: 2012-03-09