NCT02107664

The Palliative Radiotherapy And Inflammation Study - PRAIS

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 580 (actual)
• Sponsor: Norwegian University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Neoplasm Metastasis
• Bone Neoplasms

Interventions

Type	Name	Description
RADIATION	Palliative RT for bone cancer pain

Timeline

• Start date: 2013-12-01
• Primary completion: 2017-12-01
• Completion: 2018-12-01
• First posted: 2014-04-08
• Last updated: 2019-03-22

Locations

3 sites across 1 country: Norway