The Palliative Radiotherapy And Inflammation Study - PRAIS

Completed

• Conditions: Neoplasm Metastasis; Bone Neoplasms
• Interventions: Radiation: Palliative RT for bone cancer pain

• Registration Number: NCT02107664
• Lead Sponsor: Norwegian University of Science and Technology

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-04-04
• Study First Submitted QC: 2014-04-04
• Study First Posted: 2014-04-08
• Primary Completion: 2017-12
• Study Completion: 2018-12
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-20
• Last Update Posted: 2019-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 580

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Radiation therapy for bone cancer pain	Palliative RT for bone cancer pain	The group includes all cancer diagnoses, and different fractions of RT planned.

Primary Outcome Measures

Name	Time	Method
Pain response	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

Secondary Outcome Measures

Name	Time	Method
Depression	1 year	Depression symptoms last 2 weeks scored i patient Health Questionnaire (PHQ) - 9.
Cachexia	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%

Trial Locations

Locations (3)

Dept of Oncology, Oslo Universitetssykehus; 🇳🇴 Oslo, Norway

Dept of Oncology, Ålesund sjukehus; 🇳🇴 Ålesund, Norway

Dept of Oncology, St Olavs Hospital; 🇳🇴 Trondheim, Norway