The Palliative Radiotherapy And Inflammation Study - PRAIS

Neoplasm Metastasis Clinical Trial

— PRAIS  

Official title:

The Palliative Radiotherapy And Inflammation Study: Palliative Radiotherapy of Bone Metastasis. Classification, Inflammatory Biomarkers, and Longitudinal Clinical Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02107664
• Other study ID #: 2013/1126
• Status: Completed
• Start date: December 2013
• Est. completion date: December 2018

Study information

• Verified date: March 2019
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Bone Neoplasms
• Inflammation
• Neoplasm Metastasis
• Neoplasms

Intervention

Radiation:
• Palliative RT for bone cancer pain

Locations

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

Sponsors (5)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Alesund Hospital, European palliative care research centre, Oslo University Hospital, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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

Outcome

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