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The Palliative Radiotherapy And Inflammation Study - PRAIS (PRAIS)

The Palliative Radiotherapy And Inflammation Study: Palliative Radiotherapy of Bone Metastasis. Classification, Inflammatory Biomarkers, and Longitudinal Clinical Follow-up

Radiation therapy (RT) is one of the primary treatments for bone cancer pain due to metastatic cancer disease. About 6 of 10 patients obtain pain relief from RT. There are no established predictors that can be used to select patients that respond to RT. This raises the need to identify potential clinical characteristics and biomarkers that may better select patients for RT. A similar argument can be stated for the development of cachexia; there are currently no predictors that can identify patients who will develop cachexia later in the cancer disease trajectory. Cancer symptoms can be related to inflammation. Both pain, cachexia and depression are associated with inflammation in experimental and preclinical studies . Still, the clinical data on the relationship between inflammation and pain or cachexia are sparse. This is especially true for longitudinal follow-up studies.

This study will include 1000 adult patients in a multicenter, multinational longitudinal observation study of patients who receive radiation therapy for bone cancer pain. Demographic data, clinical variables, genetic biomarkers and inflammatory substances will be assessed before start of RT. The primary analysis in the study is to identify potential predictors for pain relief from RT. During follow up the study will also explore for predictors for development of cachexia and which inflammatory substances that are associated with changes in pain intensity, depression and development of cachexia.

研究概览

研究类型

观察性的

注册 (实际的)

580

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

      • Oslo、挪威
        • Dept of Oncology, Oslo Universitetssykehus
      • Trondheim、挪威、7006
        • Dept of Oncology, St Olavs Hospital
      • Ålesund、挪威
        • Dept of Oncology, Ålesund sjukehus

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

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients admitted to palliative RT for bone cancer pain

描述

Inclusion criteria:

  • Verified cancer diagnosis (based on radiological, histological, cytological or operative evidence). Those with hematological malignancies are also eligible.
  • Bone metastasis verified either by bone x-ray, bone scan, computer tomography (CT) or magnetic resonance imaging (MRI)
  • Patients that are about to undergo radiotherapy with palliative intent for painful bone metastasis
  • Radiotherapy should be administered within one week after baseline observations are obtained
  • Age ≥18 years
  • Patient is able to comply with trial procedures.

Exclusion criteria:

  • Pathological fracture in long bones (e.g femora or humeral shaft fractures)
  • Patients not consenting to participate in the study
  • On-going RT or RT administered within the last 4 weeks
  • Patients who are not able to follow the trial procedures
  • Previous participation in this study

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

队列和干预

团体/队列
干预/治疗
Radiation therapy for bone cancer pain
The group includes all cancer diagnoses, and different fractions of RT planned.

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 response
大体时间:3 - 8 weeks

Complete response implies a numeric rate scale (NRS) worst pain of zero at the treated site on an 11-point rating scale, with no concomitant increase in analgesic intake.

Partial response is defined as either i) pain reduction of two or more at the treated site on the 11-point NRS worst pain rating scale together with no increase in analgesic intake, or ii) reduction in analgesic intake of at least 25 per cent from baseline without an increase in pain score at the treated site.

An "intermediate response" category represents any response other than complete or partial response or pain progression

3 - 8 weeks

次要结果测量

结果测量
措施说明
大体时间
Cachexia
大体时间:1 year
Cachexia defined as a) Weight loss >5% over past 6 months (in absence of simple starvation); or b) body mass index (BMI) <20 and any degree of weight loss >2%; or c) Appendicular skeletal muscle index consistent with sarcopenia (males <7・26 kg/m2; females <5・45 kg/m2) and any degree of weight loss >2%
1 year
Depression
大体时间:1 year
Depression symptoms last 2 weeks scored i patient Health Questionnaire (PHQ) - 9.
1 year

其他结果措施

结果测量
措施说明
大体时间
Inflammatory Biomarkers
大体时间:1 year
Change in inflammatory biomarkers during longitudinal follow-up in relation to change in pain, depression and cachexia.
1 year

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:Pål Klepstad, phd md、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 (实际的)

2013年12月1日

初级完成 (实际的)

2017年12月1日

研究完成 (实际的)

2018年12月1日

研究注册日期

首次提交

2014年4月4日

首先提交符合 QC 标准的

2014年4月4日

首次发布 (估计)

2014年4月8日

研究记录更新

最后更新发布 (实际的)

2019年3月22日

上次提交的符合 QC 标准的更新

2019年3月20日

最后验证

2019年3月1日

更多信息

与本研究相关的术语

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.

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