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.

Study Overview

• Status: Completed
• Conditions: Neoplasm Metastasis; Bone Neoplasms
• Intervention / Treatment: Radiation: Palliative RT for bone cancer pain

• Study Type: Observational
• Enrollment (Actual): 580

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to palliative RT for bone cancer pain

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Radiation therapy for bone cancer pain; The group includes all cancer diagnoses, and different fractions of RT planned.	Radiation: Palliative RT for bone cancer pain

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory Biomarkers	Change in inflammatory biomarkers during longitudinal follow-up in relation to change in pain, depression and cachexia.	1 year

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: Oslo University Hospital; St. Olavs Hospital; Alesund Hospital; European palliative care research centre
• Investigators: Study Director: Pål Klepstad, phd md, Norwegian University of Science and Technology

Publications and helpful links

General Publications

• Habberstad R, Froseth TCS, Aass N, Abramova T, Baas T, Morkeset ST, Caraceni A, Laird B, Boland JW, Rossi R, Garcia-Alonso E, Stensheim H, Loge JH, Hjermstad MJ, Bjerkeset E, Bye A, Lund JA, Solheim TS, Vagnildhaug OM, Brunelli C, Damas JK, Mollnes TE, Kaasa S, Klepstad P. The Palliative Radiotherapy and Inflammation Study (PRAIS) - protocol for a longitudinal observational multicenter study on patients with cancer induced bone pain. BMC Palliat Care. 2018 Sep 28;17(1):110. doi: 10.1186/s12904-018-0362-9.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: April 4, 2014
• First Submitted That Met QC Criteria: April 4, 2014
• First Posted (Estimate): April 8, 2014

Study Record Updates

• Last Update Posted (Actual): March 22, 2019
• Last Update Submitted That Met QC Criteria: March 20, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Depression; Inflammation; Radiotherapy; Cachexia
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Musculoskeletal Diseases; Neoplastic Processes; Bone Diseases; Neoplasms; Inflammation; Neoplasm Metastasis; Bone Neoplasms
• Other Study ID Numbers: 2013/1126