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dc.contributor.authorHabberstad, Ragnhild
dc.contributor.authorSalvesen Frøseth, Trude Camilla
dc.contributor.authorAass, Nina
dc.contributor.authorAbramova, Tatiana
dc.contributor.authorBaas, Theo
dc.contributor.authorTessem Mørkeset, Siri
dc.contributor.authorCaraceni, Augusto
dc.contributor.authorLaird, Barry
dc.contributor.authorBoland, Jason W.
dc.contributor.authorRossi, Romina
dc.contributor.authorGarcia-Alonso, Elena
dc.contributor.authorStensheim, Hanne
dc.contributor.authorHåvard Loge, Jon
dc.contributor.authorHjermstad, Marianne J.
dc.contributor.authorBjerkeset, Ellen
dc.contributor.authorBye, Asta
dc.contributor.authorLund, Jo-Åsmund
dc.contributor.authorSolheim, Tora S.
dc.contributor.authorVagnildhaug, Ola Magne
dc.contributor.authorBrunelli, Cinzia
dc.contributor.authorDamås, Jan Kristian
dc.contributor.authorMollnes, Tom Eirik
dc.contributor.authorKaasa, Stein
dc.contributor.authorKlepstad, Pål
dc.description.abstractBackground: Radiation therapy (RT) results in pain relief for about 6 of 10 patients with cancer induced bone pain (CIBP) caused by bone metastases. The high number of non-responders, the long median time from RT to pain response and the risk of adverse effects, makes it important to determine predictors of treatment response. Clinical features such as cancer type, performance status and pain intensity, and biomarkers for osteoclast activity are proposed as predictors of response to RT. However, results are inconsistent and there is a need for better predictors of RT response. 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. Experimental and preclinical studies show that pain, depression and cachexia are related to inflammation. However, it is not known if inflammatory biomarkers can predict CIBP, depression or development of cachexia. Methods: This multicenter, multinational longitudinal observational study will include 600 adult patients receiving RT for CIBP. Demographic data, clinical variables, osteoclast and inflammatory biomarkers will be assessed before start of RT, and 3, 8, 16, 24 and 52 weeks after last course of RT. The primary aim of the study is to identify potential predictors for pain relief from RT. Secondary aims are to explore potential predictors for development of cachexia, the longitudinal relationship between pain intensity and depression, and if inflammatory biomarkers are associated with changes in pain intensity, cachexia and depression during one-year follow up. Discussion: The immediate clinical implication of the PRAIS study is to identify potential predictive factors for a RT response on CIBP, and thereby reduce non-efficacious RT. Patient benefits are fewer hospital visits, reduced risk of adverse effects and more individualized pain treatment. The long-term clinical implication of the PRAIS study is to improve the knowledge about inflammation in relation to CIBP, cachexia and depression and potentially identify associations and mechanisms that can be targeted for treatment. Trial registration: NCT02107664 , date of registration April 8, 2014 (retrospectively registered). Trial sponsor: The European Palliative Care Research Centre (PRC), Department of Clinical and Molecular Medicine, NTNU, Faculty of medicine and Health Sciences, Trondheim, N-7491, Norway.ca_ES
dc.description.sponsorshipThe Palliative Radiotherapy and Inflammation Study (PRAIS) is funded by a non-restricted grant given by the Norwegian Cancer Society (NCS) to the European Palliative Care Research Centre (PRC). In addition, the study has financing for a PhD scholarship from the Liaison Committee for Education, Research and Innovation in Central Norway. The study sponsors and funders are not involved in data collection, analyses, interpretation or publication of dataca_ES
dc.publisherBioMed Centralca_ES
dc.relation.isformatofReproducció del document publicat a
dc.relation.ispartofBMC Palliative Care, 2018, vol. 17, núm. 110ca_ES
dc.rightscc-by (c) Habberstad et al., 2018ca_ES
dc.subjectRadiation therapyca_ES
dc.subjectBone metastasesca_ES
dc.titleThe Palliative Radiotherapy and Inflammation Study (PRAIS) - protocol for a longitudinal observational multicenter study on patients with cancer induced bone painca_ES

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