Neoplasm Metastasis Clinical Trial
— PRAISOfficial title:
The Palliative Radiotherapy And Inflammation Study: Palliative Radiotherapy of Bone Metastasis. Classification, Inflammatory Biomarkers, and Longitudinal Clinical Follow-up
NCT number | NCT02107664 |
Other study ID # | 2013/1126 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 2013 |
Est. completion date | December 2018 |
Verified date | March 2019 |
Source | Norwegian University of Science and Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 580 |
Est. completion date | December 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Norway | Dept of Oncology, Ålesund sjukehus | Ålesund | |
Norway | Dept of Oncology, Oslo Universitetssykehus | Oslo | |
Norway | Dept of Oncology, St Olavs Hospital | Trondheim |
Lead Sponsor | Collaborator |
---|---|
Norwegian University of Science and Technology | Alesund Hospital, European palliative care research centre, Oslo University Hospital, St. Olavs Hospital |
Norway,
Habberstad R, Frøseth TCS, Aass N, Abramova T, Baas T, Mørkeset ST, Caraceni A, Laird B, Boland JW, Rossi R, Garcia-Alonso E, Stensheim H, Loge JH, Hjermstad MJ, Bjerkeset E, Bye A, Lund JÅ, Solheim TS, Vagnildhaug OM, Brunelli C, Damås 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Inflammatory Biomarkers | Change in inflammatory biomarkers during longitudinal follow-up in relation to change in pain, depression and cachexia. | 1 year | |
Primary | 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 | |
Secondary | 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 | |
Secondary | Depression | Depression symptoms last 2 weeks scored i patient Health Questionnaire (PHQ) - 9. | 1 year |
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