Analgesic Effect of Olanzapine in Cancer Pain: A Double-Blind Randomized Placebo-Controlled Parallel Group Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- Two-point pain improvement from baseline (0-10 numeric pain rating scale)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive oral opioid and oral placebo once daily for 4 weeks.
干预措施: placebo (Other)
Arm II
Patients receive oral opioid and 2.5 mg oral olanzapine once daily for 4 weeks.
干预措施: olanzapine (Drug)
Arm III
Patients receive oral opioid and 5 mg oral olanzapine once daily for 4 weeks.
干预措施: olanzapine (Drug)
结局指标
主要结局
Two-point pain improvement from baseline (0-10 numeric pain rating scale)
次要结局
- Comparison of active treatment vs placebo
- Effect of olanzapine on opiod adverse effects
- Relationships between endpoints