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The Palliative Radiotherapy And Inflammation Study - PRAIS (PRAIS)

20. marts 2019 opdateret af: Norwegian University of Science and Technology

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

580

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Norge
      • Oslo, Norge
        • Dept of Oncology, Oslo Universitetssykehus
      • Trondheim, Norge, 7006
        • Dept of Oncology, St Olavs Hospital
      • Ålesund, Norge
        • Dept of Oncology, Ålesund sjukehus

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients admitted to palliative RT for bone cancer pain

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Radiation therapy for bone cancer pain
The group includes all cancer diagnoses, and different fractions of RT planned.
Stråling: Palliative RT for bone cancer pain

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain response
Tidsramme: 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
3 - 8 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cachexia
Tidsramme: 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%
1 year
Depression
Tidsramme: 1 year
Depression symptoms last 2 weeks scored i patient Health Questionnaire (PHQ) - 9.
1 year

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Inflammatory Biomarkers
Tidsramme: 1 year
Change in inflammatory biomarkers during longitudinal follow-up in relation to change in pain, depression and cachexia.
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Norwegian University of Science and Technology

Samarbejdspartnere

Oslo University Hospital
St. Olavs Hospital
Alesund Hospital
European palliative care research centre

Efterforskere

  • Studieleder: Pål Klepstad, phd md, Norwegian University of Science and Technology

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. december 2013

Primær færdiggørelse (Faktiske)

1. december 2017

Studieafslutning (Faktiske)

1. december 2018

Datoer for studieregistrering

Først indsendt

4. april 2014

Først indsendt, der opfyldte QC-kriterier

4. april 2014

Først opslået (Skøn)

8. april 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. marts 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. marts 2019

Sidst verificeret

1. marts 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2013/1126

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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