The Palliative Radiotherapy And Inflammation Study - PRAIS

NCT02107664 | Completed

• 1 other identifier: 2013/1126
• Study Type: observational
• Target: 580
• Locations: 1 country
• Sites: 3

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.

Conditions

Neoplasm Metastasis; Bone Neoplasms

Keywords

Radiotherapy; Cachexia; Inflammation; Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Cachexia

  1 year

• Depression

  1 year

Other Outcomes (1)

• Inflammatory Biomarkers

  1 year

Study Arms (1)

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

Interventions

Palliative RT for bone cancer pain RADIATION

Radiation therapy for bone cancer pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to palliative RT for bone cancer pain

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• European palliative care research centre: collaborator
• St. Olavs Hospital: collaborator
• Alesund Hospital: collaborator
• Oslo University Hospital: collaborator

Study Sites (3)

Dept of Oncology, Ålesund sjukehus

Ålesund, Norway

Location

Dept of Oncology, Oslo Universitetssykehus

Oslo, Norway

Location

Dept of Oncology, St Olavs Hospital

Trondheim, 7006, Norway

Location

Related Publications (3)

• 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.

  PMID: 30266081 BACKGROUND

• Urrizola A, Dajani O, Aass N, Bjerkeset E, Hjermstad MJ, Kaasa S, Klepstad P, Pirnat A, Raaness I, Steinsheim H, Bye A. Nutrition impact symptom monitoring and weight loss outcomes: a longitudinal radiotherapy study. BMJ Support Palliat Care. 2025 Jun 27;15(4):522-525. doi: 10.1136/spcare-2024-004939.

  PMID: 38862183 DERIVED

• Bye A, Bjerkeset E, Stensheim H, Loge JH, Hjermstad MJ, Klepstad P, Habberstad R, Kaasa S, Aass N. Benefits of Study Participation for Patients with Advanced Cancer Receiving Radiotherapy: A Prospective Observational Study. Palliat Med Rep. 2022 Nov 3;3(1):264-271. doi: 10.1089/pmr.2022.0044. eCollection 2022.

  PMID: 36876292 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Genetic and Cytokine Analyses

MeSH Terms

Conditions

Neoplasm Metastasis; Bone Neoplasms; Cachexia; Inflammation; Depression

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Thinness; Behavioral Symptoms; Behavior

Study Officials

• Pål Klepstad, phd md

  Norwegian University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2014
• First Posted: April 8, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: March 22, 2019

Record last verified: 2019-03

Locations

NO (3)