The Palliative Radiotherapy And Inflammation Study - PRAIS

Study Overview
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Brief Summary
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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.

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

Conditions
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Neoplasm Metastasis, Bone Neoplasms

Intervention / Treatment
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* Radiation: Palliative RT for bone cancer pain


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Radiation therapy for bone cancer pain<br>The group includes all cancer diagnoses, and different fractions of RT planned. | Radiation: Palliative RT for bone cancer pain<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain response | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cachexia | 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 | Depression symptoms last 2 weeks scored i patient Health Questionnaire (PHQ) - 9. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiotherapy, Cachexia, Inflammation, Depression