Clinical trial NCT02107664: The Palliative Radiotherapy And Inflammation Study - PRAIS
Official title: The Palliative Radiotherapy And Inflammation Study: Palliative Radiotherapy of Bone Metastasis. Classification, Inflammatory Biomarkers, and Longitudinal Clinical Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasm Metastasis
Bone Neoplasms
Keywords: Radiotherapy
Cachexia
Inflammation
Depression
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: European palliative care research centre
name: St. Olavs Hospital
name: Alesund Hospital
name: Oslo University Hospital
First posted: 2014-04-08
Enrollment: 580
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to palliative RT for bone cancer pain

Brief summary: 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.


Eligibility criteria: Inclusion criteria:

* Verified cancer diagnosis (based on radiological, histological, cytological or operative evidence). Those with hematological malignancies are also eligible.
* Bone metastasis verified either by bone x-ray, bone scan, computer tomography (CT) or magnetic resonance imaging (MRI)
* Patients that are about to undergo radiotherapy with palliative intent for painful bone metastasis
* Radiotherapy should be administered within one week after baseline observations are obtained
* Age ≥18 years
* Patient is able to comply with trial procedures.

Exclusion criteria:

* Pathological fracture in long bones (e.g femora or humeral shaft fractures)
* Patients not consenting to participate in the study
* On-going RT or RT administered within the last 4 weeks
* Patients who are not able to follow the trial procedures
* Previous participation in this study

Primary outcomes:
measure: Pain response
timeFrame: 3 - 8 weeks
Secondary outcomes:
measure: Cachexia
timeFrame: 1 year
measure: Depression
timeFrame: 1 year
Other outcomes:
measure: Inflammatory Biomarkers
timeFrame: 1 year
Locations:
city: Oslo
country: Norway
facility: Dept of Oncology, Oslo Universitetssykehus
city: Trondheim
country: Norway
facility: Dept of Oncology, St Olavs Hospital
city: Ålesund
country: Norway
facility: Dept of Oncology, Ålesund sjukehus
Study officials:
affiliation: Norwegian University of Science and Technology
name: Pål Klepstad, phd md
role: STUDY_DIRECTOR
References:
citation: 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.