Efficacy and Safety of Opioid Rotation Compared With Opioid Dose Escalation in Patients With Moderate to Severe Cancer Pain - Open Label, Randomized, Prospective Study
试验速览
- 阶段
- 3 期
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- The rate of successful pain control defined as a 30% or 2-point reduction in the numeric rating scale
研究概览
简要总结
Although opioid rotation is well known treatment modality in reducing pain and opioid-induced neurotoxicity, it is not established whether opioid rotation is more appropriate or opioid escalation is more effective in controlling significant pain in cancer patients under opioid medication.
- The purpose of this study is to determine effective therapy out of opioid rotation and opioid dose escalation in patients with moderate to severe cancer pain who have been already treated with strong opioid.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years
- •patients who are being treated with one of strong opioids including oral oxycodone, oral hydromorphone, or fentanyl patch with range from 60 mg to 200 mg of oral morphine equivalent daily dose (MEDD)
- •moderate to severe cancer pain (numeric rating scale more than 3) at screening
- •patients without uncontrolled adverse effects associated with currently applied opioid
排除标准
- •previous opioid rotation
- •unable to take oral medication
- •life expectancy less than a month
- •newly started chemotherapy and/or radiotherapy within past 2 weeks of screening
- •serum aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase > 2.5 times of upper normal limit
- •serum total bilirubin or creatinine > 1.5 times of upper normal limit
研究组 & 干预措施
opioid rotation
Patients who are randomized to opioid rotation are treated with strong opioid other than currently used strong opioid (Reduce the dose by 25%-50% to allow for incomplete cross-tolerance between different opioids).
- oral oxycodone : convert to oral hydromorphone or fentanyl patch
- oral hydromorphone : convert to oral oxycodone or fentanyl patch
- fentanyl patch : convert to oral oxycodone or oral hydromorphone
干预措施: oral oxycodone (Drug)
opioid rotation
Patients who are randomized to opioid rotation are treated with strong opioid other than currently used strong opioid (Reduce the dose by 25%-50% to allow for incomplete cross-tolerance between different opioids).
- oral oxycodone : convert to oral hydromorphone or fentanyl patch
- oral hydromorphone : convert to oral oxycodone or fentanyl patch
- fentanyl patch : convert to oral oxycodone or oral hydromorphone
干预措施: oral hydromorphone (Drug)
opioid rotation
Patients who are randomized to opioid rotation are treated with strong opioid other than currently used strong opioid (Reduce the dose by 25%-50% to allow for incomplete cross-tolerance between different opioids).
- oral oxycodone : convert to oral hydromorphone or fentanyl patch
- oral hydromorphone : convert to oral oxycodone or fentanyl patch
- fentanyl patch : convert to oral oxycodone or oral hydromorphone
干预措施: fentanyl patch (Drug)
opioid dose escalation
Patients who are randomized to opioid dose escalation will be treated cancer pain by escalation dose of same strong opioid.
- oral oxycodone : maintain oral oxycodone and titrate the dose
- oral hydromorphone : maintain oral hydromorphone and titrate the dose
- fentanyl patch : maintain fentanyl patch and titrate the dose
干预措施: oral oxycodone (Drug)
opioid dose escalation
Patients who are randomized to opioid dose escalation will be treated cancer pain by escalation dose of same strong opioid.
- oral oxycodone : maintain oral oxycodone and titrate the dose
- oral hydromorphone : maintain oral hydromorphone and titrate the dose
- fentanyl patch : maintain fentanyl patch and titrate the dose
干预措施: oral hydromorphone (Drug)
opioid dose escalation
Patients who are randomized to opioid dose escalation will be treated cancer pain by escalation dose of same strong opioid.
- oral oxycodone : maintain oral oxycodone and titrate the dose
- oral hydromorphone : maintain oral hydromorphone and titrate the dose
- fentanyl patch : maintain fentanyl patch and titrate the dose
干预措施: fentanyl patch (Drug)
结局指标
主要结局
The rate of successful pain control defined as a 30% or 2-point reduction in the numeric rating scale
时间窗: Eighteen months
次要结局
未报告次要终点
研究者
Jung Hun Kang
Associate Professor
Gyeongsang National University Hospital