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| Name | Class |
|---|---|
| European palliative care research centre | UNKNOWN |
| St. Olavs Hospital | OTHER |
| Alesund Hospital | OTHER |
| Oslo University Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation therapy for bone cancer pain | The group includes all cancer diagnoses, and different fractions of RT planned. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palliative RT for bone cancer pain | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cachexia | Cachexia defined as a) Weight loss >5% over past 6 months (in absence of simple starvation); or b) body mass index (BMI) <20 and any degree of weight loss >2%; or c) Appendicular skeletal muscle index consistent with sarcopenia (males <7・26 kg/m2; females <5・45 kg/m2) and any degree of weight loss >2% | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory Biomarkers | Change in inflammatory biomarkers during longitudinal follow-up in relation to change in pain, depression and cachexia. | 1 year |
Inclusion criteria:
Exclusion criteria:
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Patients admitted to palliative RT for bone cancer pain
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| Name | Affiliation | Role |
|---|---|---|
| PÃ¥l Klepstad, phd md | Norwegian University of Science and Technology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Oncology, Ã…lesund sjukehus | Ã…lesund | Norway | ||||
| Dept of Oncology, Oslo Universitetssykehus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30266081 | Background | 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. | |
| 38862183 |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D001859 | Bone Neoplasms |
| D002100 | Cachexia |
| D007249 | Inflammation |
| D003863 | Depression |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OTHER |
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Genetic and Cytokine Analyses
| Depression |
Depression symptoms last 2 weeks scored i patient Health Questionnaire (PHQ) - 9. |
| 1 year |
| Oslo |
| Norway |
| Dept of Oncology, St Olavs Hospital | Trondheim | 7006 | Norway |
| Derived |
| 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. |
| 36876292 | 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. |
| D009371 | Neoplasms by Site |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013851 | Thinness |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |