Abstract
BackgroundRadiation 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.MethodsThis 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.DiscussionThe 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 registrationClinicalTrials.gov NCT02107664, date of registration April 8, 2014 (retrospectively registered).Trial sponsorThe European Palliative Care Research Centre (PRC), Department of Clinical and Molecular Medicine, NTNU, Faculty of medicine and Health Sciences, Trondheim, N-7491, Norway.
Highlights
Radiation therapy (RT) results in pain relief for about 6 of 10 patients with cancer induced bone pain (CIBP) caused by bone metastases
The long-term clinical implication of the palliative radiotherapy and inflammation study (PRAIS) study is to improve the knowledge about inflammation in relation to Cancer induced bone pain (CIBP), cachexia and depression and potentially identify associations and mechanisms that can be targeted for treatment
In a cross-sectional study that controlled for disease load, we demonstrated that by only using the 5 psychological depression symptoms for defining depression disorder, we could circumvent the challenge of the overlap between the somatic depression symptoms and symptoms of the cancer [44] [45]
Summary
Design A multicenter, international longitudinal observational study of patients commencing palliative RT for CIBP. Clinical variables At inclusion the following information will be collected (variables included as independent variables in the primary analyses are denoted with an asterisk): Age*, gender*, ethnicity, height, comorbidity* (Charlson Comorbidity Index) [51], Karnofsky performance status* [52], living situation, educational level, alcohol use, smoking status*, type of department (palliative care unit, surgical ward, general oncology ward, out-patient clinic, other), oncological history related to the current cancer disease (tumor diagnosis*, time since cancer diagnosis*, presence of metastases other than bone*, osteolytic metastasis at each planned site for RT*, soft tissue expansion at each planned radiation site*, previous and on-going anti-cancer treatment: (RT, surgery, chemotherapy, hormonal treatment, other interventions – for the primary analyses current oncological treatment other than RT (Y/N)*), planned RT (fractions*, total dose* and anatomical region; narrow to radiation location in weight bearing bone (Y/N) for the primary analyses*, re-irradiation, previous pain treatments (duration of opioid treatment and previous unsuccessful trials with other opioids) and medications and doses for the previous 24 h Research question 1: Which are the clinical predictors and biomarkers predictors of pain response to palliative RT for CIBP?
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