Corticosteroids for Cancer Pain
研究概览
详细说明
Patients are required to use strong opioids before entering the study. Weak opioids are allowed if patients have short acting strong opioids as rescue-medication. The scheduled opioids shall be stable last 48 hours before entering the study and will be kept stable during the study period. Patients may use as much short acting rescue-medication as they require. No other analgesic medication should be started during the study period.
The study is a multicentre trial. Patients will be randomized according to 1. study centre (No 1-5) and 2. pain mechanism: skeletal metastases (yes/no).
Patients are evaluated Day 0 and Day 7 by palliative care physician. Patients will be contacted by phone Day 1-6 and will fill in questionnaire regarding symptoms and analgesic usage. Patients will be contacted Day 14 and 21 to fill in questionnaires regarding symptoms, quality of life and side effects.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Bergen、挪威、5009
- Haraldsplass Diakonale sykehus
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Drammen、挪威、3004
- Sykehuset Buskerud HF
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Kristiansand、挪威、4606
- Sørlandet Sykehus HF
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Oslo、挪威、0407
- Oslo universitetssykehus, Ullevål
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Skien、挪威、3712
- Sykehuset Telemark HF
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Trondheim、挪威、7006
- St Olavs Hospital HF
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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
Inclusion Criteria:
- Verified malignant disease
- Receiving a scheduled strong or weak opioid
- Insufficient pain control: Average pain last 24 h: ≥ 4 (NRS 0-10)
- Given informed consent according to the ethical guidelines
- Able to complete planned assessment schedules
- ≥ 18 years of age
- Life expectancy > 1 month
Exclusion Criteria:
- Excruciating pain (average pain ≥ 8) (These patients should be considered as emergency patients. Patients may be eligible for the study after stabilization)
- Dose adjustment in scheduled opioid medication last 48 hours
- Concurrent medication with NSAIDs (Patients are eligible for the study one week after NSAIDs are discontinued)
- Receiving radiotherapy within 4 weeks before entering the study or planned within the study period
- Started systemic treatment (chemotherapy, hormone therapy or bisphosphonates) within 4 weeks before entering the study Patients who have received chemotherapy for more than 4 weeks are eligible for the study if it is more than 7 days since receiving the last dose and they are not having the next dose within the study period
- Manifest spinal cord compression or in need of bone surgery
- Severe cognitive impairment
- Previously on steroids during the last 4 weeks
- Diabetes mellitus
- Known peptic ulcer disease
- Systemic fungal disease, patients vaccinated with viable viruses, and patients with known allergies to the study medication (MethylPrednisolone)
- Female patients who are pregnant or lactating.
- Women of reproductive potential not willing or unable to employ an effective method of contraception (be sterilized, using IUD or oral contraception)
- Patients using following medication: cyclosporin, erythromycin, phenobarbital, phenytoin, carbamazepin, ketoconazole, methotrexate, ciclofosfamide, rifampicin, aprepitant and diltiazem.
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
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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安慰剂比较:安慰剂
每天两次安慰剂胶囊
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Custom made capsules, Lactose, administered twice daily, intervention period 7 days
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实验性的:Methylprednisolone
Methylprednisolone 16 mg twice daily
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Custom made capsules, Methylprednisolone 16 mg twice daily, intervention period 7 days.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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pain intensity at Day 7
大体时间:7 days
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change of pain intensity at Day 7, measured by "average pain for the last 24 hours" (NRS 0-10).
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7 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
fatigue
大体时间:7 days
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change of fatigue measured by EORTC QLQ30 and ESAS
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7 days
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appetite
大体时间:7 days
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change of appetite measured by EORTC QLQ30 and ESAS
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7 days
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Overall effect satisfaction
大体时间:7 days
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Overall effect measured by a global satisfaction-question ("How is your overall benefit from the medication?"
NRS: 0= No important benefit 10=very important benefit).
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7 days
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sleep quality
大体时间:7 days
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change of sleep quality measured by Pittsburgh Sleep Quality Index
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7 days
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analgesic usage
大体时间:7 days
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change of analgesic usage measured by morphine equivalents.
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7 days
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Pain now and average pain last 24 hrs
大体时间:7 days
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Pain now and average pain last 24 hours measured by daily NRS (Numeric rating scale)(ESAS)
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7 days
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合作者和调查者
调查人员
- 研究主任:Stein Kaasa, MD PhD prof、Norwegian University of Science and Technology
出版物和有用的链接
一般刊物
- Paulsen O, Klepstad P, Rosland JH, Aass N, Albert E, Fayers P, Kaasa S. Efficacy of methylprednisolone on pain, fatigue, and appetite loss in patients with advanced cancer using opioids: a randomized, placebo-controlled, double-blind trial. J Clin Oncol. 2014 Oct 10;32(29):3221-8. doi: 10.1200/JCO.2013.54.3926. Epub 2014 Jul 7.
- Jakobsen G, Engstrom M, Hjermstad MJ, Rosland JH, Aass N, Albert E, Kaasa S, Fayers P, Klepstad P, Paulsen O. The short-term impact of methylprednisolone on patient-reported sleep in patients with advanced cancer in a randomized, placebo-controlled, double-blind trial. Support Care Cancer. 2021 Apr;29(4):2047-2055. doi: 10.1007/s00520-020-05693-6. Epub 2020 Aug 27.
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 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Methylprednisolone的临床试验
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Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)招聘中弥漫性大 B 细胞淋巴瘤 | 高级别 B 细胞淋巴瘤 | 双表达淋巴瘤 | 具有 MYC 和 BCL2 或 BCL6 重排的高级别 B 细胞淋巴瘤 | 具有 MYC、BCL2 和 BCL6 重排的高级别 B 细胞淋巴瘤美国