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

Habberstad, Ragnhild; Frøseth, Trude Camilla Salvesen; Aass, Nina; Abramova, Tatiana; Baas, Theo; Mørkeset, Siri Tessem; Caraceni, Augusto; Laird, Barry; Boland, Jason W.; Rossi, Romina; Garcia-Alonso, Elena; Stensheim, Hanne; Loge, Jon Håvard; Hjermstad, Marianne Jensen; Bjerkeset, Ellen; Bye, Asta; Lund, Jo-Åsmund; Solheim, Tora Skeidsvoll; Vagnildhaug, Ola Magne; Brunelli, Cinzia; Damås, Jan Kristian; Mollnes, Tom Eirik; Kaasa, Stein; Klepstad, Pål

Authors

Ragnhild Habberstad

Trude Camilla Salvesen Frøseth

Nina Aass

Tatiana Abramova

Theo Baas

Siri Tessem Mørkeset

Augusto Caraceni

Barry Laird

Romina Rossi

Elena Garcia-Alonso

Hanne Stensheim

Jon Håvard Loge

Marianne Jensen Hjermstad

Ellen Bjerkeset

Asta Bye

Jo-Åsmund Lund

Tora Skeidsvoll Solheim

Ola Magne Vagnildhaug

Cinzia Brunelli

Jan Kristian Damås

Tom Eirik Mollnes

Stein Kaasa

Pål Klepstad



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.

Citation

Habberstad, R., Frøseth, T. C. S., Aass, N., Abramova, T., Baas, T., Mørkeset, S. T., Caraceni, A., Laird, B., Boland, J. W., Rossi, R., Garcia-Alonso, E., Stensheim, H., Loge, J. H., Hjermstad, M. J., Bjerkeset, E., Bye, A., Lund, J.-Å., Solheim, T. S., Vagnildhaug, O. M., Brunelli, C., …Klepstad, P. (2018). The Palliative Radiotherapy and Inflammation Study (PRAIS) - protocol for a longitudinal observational multicenter study on patients with cancer induced bone pain. BMC Palliative Care, 17(1), Article 110. https://doi.org/10.1186/s12904-018-0362-9

Journal Article Type Article
Acceptance Date Sep 17, 2018
Online Publication Date Sep 28, 2018
Publication Date Sep 28, 2018
Deposit Date Sep 29, 2018
Publicly Available Date Oct 1, 2018
Journal BMC Palliative Care
Print ISSN 1472-684X
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 17
Issue 1
Article Number 110
DOI https://doi.org/10.1186/s12904-018-0362-9
Keywords General Medicine
Public URL https://hull-repository.worktribe.com/output/1081256
Publisher URL https://bmcpalliatcare.biomedcentral.com/articles/10.1186/s12904-018-0362-9
Contract Date Oct 1, 2018

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Copyright Statement
© The Author(s). 2018

This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.






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