Opioid Rotation Versus Combination for Chronic Uncontrolled Cancer Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2,006
- 主要终点
- Change in pain score and treatment success
研究概览
简要总结
For cancer patients with inadequate pain relief, a switch to an alternative opioid is the preferred option for symptomatic improvement. However, multiple opioids are often simultaneously administered for anecdotal reasons.
The present study isdesigned to assess the analgesic profiles of two different strategies in chronic cancer pain: the opioid rotation from oxycodone to transdermal fentanyl and the combination of oral oxycodone and transdermal fentanyl.
详细描述
Patients with uncontrolled cancer pain despite treatment of oral morphine equivalent ≥100 mg/d will be randomly assigned to oral opioids to transdermal fentanyl (rotation group) or oral oxycodone plus fentanyl (combination group). Patients answer a questionnaire that included pain severity (0 to 10) and interference items at baseline and after one week. Primary outcomes are change in pain score and treatment success.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic Uncontrolled Pain That Required Stronger Opioid Therapy Than They Have Been Taking
- •Histologically Confirmed Solid Cancer
- •Aged Over 18 Years
- •Admitted in a Palliative Cancer Care Unit
排除标准
- •Uspected to Have Narcotic Abuse, Clinically Relevant CO2 Retention or Had an Active Skin Disease
- •Inability to swallow oral medication, and impaired sensory or cognitive function
- •Patients who had an active infection, uncontrolled central nervous system involvement, or on antitumor therapy of any kind
结局指标
主要结局
Change in pain score and treatment success
次要结局
- Patient satisfaction