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Neoplasm MetastasisPRAISNCT02107664

The Palliative Radiotherapy And Inflammation Study - PRAIS

An observational study of Neoplasm Metastasis and Bone Neoplasms, run by Norwegian University of Science and Technology at 3 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasm Metastasis, Bone Neoplasms
What is being tested?
Palliative RT for bone cancer pain
Type of treatment
Surgery or procedure
How many people
580 participants
Where
3 sitesNorway
Study dates
Dec 2013to Dec 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients admitted to palliative RT for bone cancer pain

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Norway3 sites

  • Dept of Oncology, Ålesund sjukehus

    Ålesund

  • Dept of Oncology, Oslo Universitetssykehus

    Oslo

  • Dept of Oncology, St Olavs Hospital

    Trondheim, 7006

Other trials in Norway

About this study

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

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.

Being tested
Palliative RT for bone cancer pain
Keywords
Radiotherapy, Cachexia, Inflammation, Depression
Medical subject headings
Neoplasm Metastasis, Bone Neoplasms, Cachexia, Inflammation, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Palliative RT for bone cancer painRadiation

Study groups in NCT02107664
Study groupRoleWhat they receive
Radiation therapy for bone cancer painThe group includes all cancer diagnoses, and different fractions of RT planned.
Receives: Radiation: Palliative RT for bone cancer pain

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 3 - 8 weeks

Secondary outcomes (2)

  1. 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%

    Measured: 1 year

  2. Depression

    Depression symptoms last 2 weeks scored i patient Health Questionnaire (PHQ) - 9.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2014 (estimated)
  2. Study startDec 2013
  3. Primary completionDec 2017
  4. Study completionDec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
580 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02107664
Sponsor's protocol ID
2013/1126
Acronym
PRAIS
Status last verified
Mar 2019
First submitted
4 Apr 2014
Last updated
22 Mar 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 30266081

  • 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.

    PubMed 38862183

  • 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.

    PubMed 36876292

Questions about this trial

What is this clinical trial studying?

An observational study of Neoplasm Metastasis and Bone Neoplasms, run by Norwegian University of Science and Technology at 3 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain response (time frame: 3 - 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02107664, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2019.

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