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

Not Applicable

Withdrawn

• Conditions: Hematopoietic/Lymphoid Cancer; Pain; Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Other: placebo; Drug: olanzapine

• Registration Number: NCT00737191
• Lead Sponsor: Mayo Clinic

Brief 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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-15
• Study First Submitted QC: 2008-08-15
• Study First Posted: 2008-08-18
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-07
• Last Update Posted: 2012-03-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm I	placebo	Patients receive oral opioid and oral placebo once daily for 4 weeks.
Arm II	olanzapine	Patients receive oral opioid and 2.5 mg oral olanzapine once daily for 4 weeks.
Arm III	olanzapine	Patients receive oral opioid and 5 mg oral olanzapine once daily for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Two-point pain improvement from baseline (0-10 numeric pain rating scale)

Secondary Outcome Measures

Name	Time	Method
Comparison of active treatment vs placebo
Effect of olanzapine on opiod adverse effects
Relationships between endpoints