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
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.
研究概览
详细说明
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.
研究类型
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
Moderate to severe cancer pain
- Pain score ≥ 7/10 (0-10 numeric pain rating scale)
- Requires strong opioids (step 3) for pain control or are already on stable doses of step 3 opioids
- Opioid induced cognitive dysfunction or cognitive impairment, defined as cognitive disorder not otherwise specified according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) allowed
No nonmalignant pain
- If patient has both malignant and nonmalignant pain, eligibility will be determined by the predominant site of pain
PATIENT CHARACTERISTICS:
- Life expectancy ≥ 3 months
- Normal renal function
- Not pregnant or nursing
- Negative pregnancy test
- Must have a telephone
- Able to complete patient questionnaires alone or with assistance
- No delirium
- No hepatic dysfunction
- No nursing home patients
- No intractable nausea or vomiting
- No true allergy or intolerance to opioids
- No gastrointestinal pathology that influences absorption of opioids
- No drug seeking behavior or recent substance abuse history
- No major depression
- No respiratory compromise
- No evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
- No evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
PRIOR CONCURRENT THERAPY:
- More than 1 month since prior radiotherapy, chemotherapy, or radionuclides
- More than 1 month since prior bisphosphonates
- No prior surgery that influences absorption of opioids
- No concurrent therapeutic procedures or treatments that influence pain
- No concurrent active radiation or antineoplastic therapies
- No concurrent retroviral therapies
- No concurrent drugs that interfere with CYP34A, CYP1A2, or CYP2D6
- No concurrent drugs that interfere with morphine metabolism
- No concurrent medications that will influence the disposition of morphine or methadone
- No other concurrent antiemetics, antianxiety, or neuroleptic agents
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Arm I
Patients receive oral opioid and oral placebo once daily for 4 weeks.
|
口头给予
|
|
实验性的:Arm II
Patients receive oral opioid and 2.5 mg oral olanzapine once daily for 4 weeks.
|
Given orally
|
|
实验性的:Arm III
Patients receive oral opioid and 5 mg oral olanzapine once daily for 4 weeks.
|
Given orally
|
研究衡量的是什么?
主要结果指标
结果测量 |
|---|
|
Two-point pain improvement from baseline (0-10 numeric pain rating scale)
|
次要结果测量
结果测量 |
|---|
|
Comparison of active treatment vs placebo
|
|
Effect of olanzapine on opiod adverse effects
|
|
Relationships between endpoints
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- CDR0000588630
- P30CA015083 (美国 NIH 拨款/合同)
- MCS930 (其他标识符:Mayo Clinic Cancer Center)
- 07-007571 (其他标识符:Mayo Clinic IRB)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.