PDF(Pubmed)
Abstract：
BACKGROUND: A third of patients with advanced cancer and bone metastasis suffer from cancer induced bone pain (CIBP), impeding quality of life, psychological distress, depression and anxiety. This study will evaluate the impact of an opioid rotation, comparing methadone rotation with other opioid rotation in patients with refractory CIBP.
METHODS: This open-label randomised controlled trial will recruit cancer patients with CIBP and inadequate pain control despite established baseline opioid and/or intolerable opioid side effects from cancer and palliative care services. Participants will be at least 18 years old, with a predicted prognosis of greater than 8 weeks, meet the core diagnostic criteria for CIBP, have a worst pain score of ≥ 4 of 10 from CIBP and/ or have opioid toxicity (graded ≥ 2 on Common Terminology Criteria for Adverse Events). Participants will have sufficiently proficient English to complete questionnaires and provide informed consent. Participants will be randomised 1:1 to be rotated to methadone to another opioid. The primary objective is to examine the impact of opioid rotation in improving CIBP by comparing analgesic efficacy, safety and tolerability in the two arms. Secondary objectives will assess changes in the intensity, duration and frequency of breakthrough pain, requirement of breakthrough analgesia, overall opioid escalation index, and time taken to observe improvement in pain reduction, pain interference and quality of life.
CONCLUSIONS: Laboratory studies suggest the involvement of neuropathic involvement in the mechanism of CIBP, though there remains no clear evidence of the routine use of neuropathic agents. Methadone as an analgesic agent may have a role to play in this cohort of patients, thus warranting further exploratory studies.
BACKGROUND: Australian New Zealand Clinical Trials Registry No: ACTRN12621000141842. Registered 11 February 2021.
METHODS: This open-label randomised controlled trial will recruit cancer patients with CIBP and inadequate pain control despite established baseline opioid and/or intolerable opioid side effects from cancer and palliative care services. Participants will be at least 18 years old, with a predicted prognosis of greater than 8 weeks, meet the core diagnostic criteria for CIBP, have a worst pain score of ≥ 4 of 10 from CIBP and/ or have opioid toxicity (graded ≥ 2 on Common Terminology Criteria for Adverse Events). Participants will have sufficiently proficient English to complete questionnaires and provide informed consent. Participants will be randomised 1:1 to be rotated to methadone to another opioid. The primary objective is to examine the impact of opioid rotation in improving CIBP by comparing analgesic efficacy, safety and tolerability in the two arms. Secondary objectives will assess changes in the intensity, duration and frequency of breakthrough pain, requirement of breakthrough analgesia, overall opioid escalation index, and time taken to observe improvement in pain reduction, pain interference and quality of life.
CONCLUSIONS: Laboratory studies suggest the involvement of neuropathic involvement in the mechanism of CIBP, though there remains no clear evidence of the routine use of neuropathic agents. Methadone as an analgesic agent may have a role to play in this cohort of patients, thus warranting further exploratory studies.
BACKGROUND: Australian New Zealand Clinical Trials Registry No: ACTRN12621000141842. Registered 11 February 2021.
摘要：
背景：三分之一的晚期癌症和骨转移患者患有癌症引起的骨痛（CIBP），阻碍生活质量，心理困扰,抑郁和焦虑。这项研究将评估阿片类药物轮换的影响，比较难治性CIBP患者美沙酮旋转与其他阿片类药物旋转。
方法：这项开放标签的随机对照试验将招募具有CIBP和疼痛控制不足的癌症患者，尽管已经确定了癌症和姑息治疗服务的基线阿片类药物和/或难以忍受的阿片类药物副作用。参与者将至少18岁，预测预后大于8周，符合CIBP的核心诊断标准，有最差的疼痛评分≥4/10的CIBP和/或有阿片类药物毒性(不良事件通用术语标准分级≥2).参与者将具有足够熟练的英语来完成问卷并提供知情同意。参与者将以1：1的比例随机分配给美沙酮与另一种阿片类药物。主要目的是通过比较镇痛疗效来检查阿片类药物旋转对改善CI血压的影响，在两个武器的安全性和耐受性。次要目标将评估强度的变化，突破性疼痛的持续时间和频率，突破性镇痛的要求，整体阿片类药物增加指数，以及观察疼痛减轻改善所需的时间，疼痛干扰和生活质量。
结论：实验室研究表明，神经性受累参与CIBP的机制，尽管仍然没有明确的证据表明常规使用神经性药物。美沙酮作为镇痛药可能在这一组患者中发挥作用，因此需要进一步的探索性研究。
背景：澳大利亚新西兰临床试验登记号：ACTRN12621000141842。2021年2月11日注册。
方法：这项开放标签的随机对照试验将招募具有CIBP和疼痛控制不足的癌症患者，尽管已经确定了癌症和姑息治疗服务的基线阿片类药物和/或难以忍受的阿片类药物副作用。参与者将至少18岁，预测预后大于8周，符合CIBP的核心诊断标准，有最差的疼痛评分≥4/10的CIBP和/或有阿片类药物毒性(不良事件通用术语标准分级≥2).参与者将具有足够熟练的英语来完成问卷并提供知情同意。参与者将以1：1的比例随机分配给美沙酮与另一种阿片类药物。主要目的是通过比较镇痛疗效来检查阿片类药物旋转对改善CI血压的影响，在两个武器的安全性和耐受性。次要目标将评估强度的变化，突破性疼痛的持续时间和频率，突破性镇痛的要求，整体阿片类药物增加指数，以及观察疼痛减轻改善所需的时间，疼痛干扰和生活质量。
结论：实验室研究表明，神经性受累参与CIBP的机制，尽管仍然没有明确的证据表明常规使用神经性药物。美沙酮作为镇痛药可能在这一组患者中发挥作用，因此需要进一步的探索性研究。
背景：澳大利亚新西兰临床试验登记号：ACTRN12621000141842。2021年2月11日注册。
