Neoplasm Metastasis Clinical Trial
Official title:
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.
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