The Palliative Radiotherapy And Inflammation Study - PRAIS (PRAIS)
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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-
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Oslo, Norge
- Dept of Oncology, Oslo Universitetssykehus
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Trondheim, Norge, 7006
- Dept of Oncology, St Olavs Hospital
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Ålesund, Norge
- Dept of Oncology, Ålesund sjukehus
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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Radiation therapy for bone cancer pain
The group includes all cancer diagnoses, and different fractions of RT planned.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pain response
Tidsramme: 3 - 8 weeks
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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
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Cachexia
Tidsramme: 1 year
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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%
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1 year
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Depression
Tidsramme: 1 year
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Depression symptoms last 2 weeks scored i patient Health Questionnaire (PHQ) - 9.
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1 year
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Inflammatory Biomarkers
Tidsramme: 1 year
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Change in inflammatory biomarkers during longitudinal follow-up in relation to change in pain, depression and cachexia.
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1 year
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Studieleder: Pål Klepstad, phd md, Norwegian University of Science and Technology
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2013/1126
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