The Palliative Radiotherapy and Inflammation Study (PRAIS) - protocol for a longitudinal observational multicenter study on patients with cancer induced bone pain

BMC Palliative Care

Jan Kristian Damås¹  Theo Baas²  Siri Tessem Mørkeset²  Tatiana Abramova²  Barry Laird³  Ragnhild Habberstad⁴  Pål Klepstad⁴  Jo-Åsmund Lund⁴  Trude Camilla Salvesen Frøseth⁴  Tora Skeidsvoll Solheim⁴  Ola Magne Vagnildhaug⁴  Jon Håvard Loge⁵  Marianne Jensen Hjermstad⁵  Ellen Bjerkeset⁵  Nina Aass⁵  Asta Bye⁵  Stein Kaasa⁵  Tom Eirik Mollnes⁶  Romina Rossi⁷  Augusto Caraceni⁸  Cinzia Brunelli⁸  Elena Garcia-Alonso⁹  Hanne Stensheim^1,10  Jason W Boland^1,11 

[1]Centre of Molecular Inflammation Research, Department of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology

[2]Department Oncology, Ålesund Hospital, Møre and Romsdal Hospital Trust

[3]Edinburgh Cancer Research Centre, University of Edinburgh

[4]European Palliative Care Research Centre (PRC), Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, NTNU, Norwegian University of Science and Technology and St. Olavs hospital, Trondheim University Hospital

[5]European Palliative Care Research Centre (PRC), Department of Oncology, Oslo University Hospital, and Institute of Clinical Medicine, University of Oslo

[6]KG Jebsen Inflammation Research Center, Department of Immunology, Oslo University Hospital

[7]Palliative Care Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS

[8]Palliative Care, Pain Therapy and Rehabilitation Unit, Fondazione IRCCS Istituto Nazionale dei Tumori

[9]Radiation Oncology Department Arnau de Vilanova University Hospital, IRB

[10]University of Oslo and Department of Oncology, Oslo University Hospital and University of Oslo

[11]Wolfson Palliative Care Research Centre, Hull York Medical School, University of Hull

关键词: Cancer;    Radiation therapy;    Palliative;    Bone metastases;    Pain;    Depression;   

DOI  :  10.1186/s12904-018-0362-9

来源: DOAJ

【 摘 要 】

Abstract Background 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 ClinicalTrials.gov 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.

【 授权许可】

Unknown