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Trial record 2 of 2 for:    prais

The Palliative Radiotherapy And Inflammation Study - PRAIS (PRAIS)

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ClinicalTrials.gov Identifier: NCT02107664
Recruitment Status : Active, not recruiting
First Posted : April 8, 2014
Last Update Posted : October 3, 2018
Sponsor:
Collaborators:
European palliative care research centre
St. Olavs Hospital
Alesund Hospital
Oslo University Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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.


Condition or disease Intervention/treatment
Neoplasm Metastasis Bone Neoplasms Radiation: Palliative RT for bone cancer pain

Study Type : Observational
Actual Enrollment : 580 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Palliative Radiotherapy And Inflammation Study: Palliative Radiotherapy of Bone Metastasis. Classification, Inflammatory Biomarkers, and Longitudinal Clinical Follow-up
Actual Study Start Date : December 2013
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Cancer

Group/Cohort Intervention/treatment
Radiation therapy for bone cancer pain
The group includes all cancer diagnoses, and different fractions of RT planned.
Radiation: Palliative RT for bone cancer pain



Primary Outcome Measures :
  1. Pain response [ Time Frame: 3 - 8 weeks ]

    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



Secondary Outcome Measures :
  1. Cachexia [ Time Frame: 1 year ]
    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%

  2. Depression [ Time Frame: 1 year ]
    Depression symptoms last 2 weeks scored i patient Health Questionnaire (PHQ) - 9.


Other Outcome Measures:
  1. Inflammatory Biomarkers [ Time Frame: 1 year ]
    Change in inflammatory biomarkers during longitudinal follow-up in relation to change in pain, depression and cachexia.


Biospecimen Retention:   Samples With DNA
Genetic and Cytokine Analyses


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to palliative RT for bone cancer pain
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02107664


Locations
Norway
Dept of Oncology, Oslo Universitetssykehus
Oslo, Norway
Dept of Oncology, St Olavs Hospital
Trondheim, Norway, 7006
Dept of Oncology, Ålesund sjukehus
Ålesund, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
European palliative care research centre
St. Olavs Hospital
Alesund Hospital
Oslo University Hospital
Investigators
Study Director: Pål Klepstad, phd md Norwegian University of Science and Technology

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT02107664     History of Changes
Other Study ID Numbers: 2013/1126
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018

Keywords provided by Norwegian University of Science and Technology:
Radiotherapy
Cachexia
Inflammation
Depression

Additional relevant MeSH terms:
Neoplasms
Inflammation
Neoplasm Metastasis
Bone Neoplasms
Pathologic Processes
Neoplastic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases