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Corticosteroids for Cancer Pain

Study hypothesis: corticosteroids are effective for pain in cancer patients. We will perform a double-blind, randomized, placebo-controlled multicentre trial evaluating the effect of Methylprednisolone 16 mg twice daily in cancer patients with pain (average pain last 24 hrs NRS > 4 (Numerical rating scale, 0 No pain, 10 worst 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

介入性

注册 (实际的)

50

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Bergen、挪威、5009
        • Haraldsplass Diakonale sykehus
      • Drammen、挪威、3004
        • Sykehuset Buskerud HF
      • Kristiansand、挪威、4606
        • Sørlandet Sykehus HF
      • Oslo、挪威、0407
        • Oslo universitetssykehus, Ullevål
      • Skien、挪威、3712
        • Sykehuset Telemark HF
      • Trondheim、挪威、7006
        • St Olavs Hospital HF

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
安慰剂比较:安慰剂
每天两次安慰剂胶囊
Custom made capsules, Lactose, administered twice daily, intervention period 7 days
实验性的:Methylprednisolone
Methylprednisolone 16 mg twice daily
Custom made capsules, Methylprednisolone 16 mg twice daily, intervention period 7 days.
其他名称:
  • Medrol (TM)

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
pain intensity at Day 7
大体时间:7 days
change of pain intensity at Day 7, measured by "average pain for the last 24 hours" (NRS 0-10).
7 days

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
change of fatigue measured by EORTC QLQ30 and ESAS
7 days
appetite
大体时间:7 days
change of appetite measured by EORTC QLQ30 and ESAS
7 days
Overall effect satisfaction
大体时间:7 days
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).
7 days
sleep quality
大体时间:7 days
change of sleep quality measured by Pittsburgh Sleep Quality Index
7 days
analgesic usage
大体时间:7 days
change of analgesic usage measured by morphine equivalents.
7 days
Pain now and average pain last 24 hrs
大体时间:7 days
Pain now and average pain last 24 hours measured by daily NRS (Numeric rating scale)(ESAS)
7 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年4月1日

初级完成 (实际的)

2012年2月1日

研究完成 (实际的)

2012年2月1日

研究注册日期

首次提交

2008年5月8日

首先提交符合 QC 标准的

2008年5月12日

首次发布 (估计)

2008年5月13日

研究记录更新

最后更新发布 (实际的)

2020年9月1日

上次提交的符合 QC 标准的更新

2020年8月30日

最后验证

2020年8月1日

更多信息

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.

Methylprednisolone的临床试验

  • Barbara Ann Karmanos Cancer Institute
    National 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
3
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