Effekten af fiskeolier på humane levermetastaser
24. juni 2013 opdateret af: University Hospitals, Leicester
Randomiseret kontrolleret undersøgelse af virkningerne af fiskeolieemulsion i total parenteral ernæring på tumorvaskularitet hos patienter med hepatiske kolorektale metastaser
Formålet med denne undersøgelse er at afgøre, om fiskeolier - en kendt kilde til omega-3 givet intravenøst (via et 'dryp') vil hjælpe med at helbrede sekundære aflejringer i leveren fra tarmkræft.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Fiskeolier har mange dokumenterede fordele for en lang række kliniske arenaer, såsom iskæmisk hjertesygdom, leddegigt og inflammatorisk tarmsygdom.
Nyere forskning har beskrevet de gavnlige virkninger af intravenøse fiskeolier for kirurgiske patienter, såsom reduceret hospitalsophold, reduceret genoperationsfrekvens og reduceret behov for intravenøse antibiotika. Disse skyldes til dels de anti-inflammatoriske virkninger af fiskeolier.
Der er evidens for, at fiskeolier også er effektive mod kræft, store befolkningsundersøgelser indikerer, at kost rig på omega-3 er forbundet med en lavere forekomst af kræft, og in vitro- og dyreforsøg påviser antitumoreffekter af fiskeolier
- Fiskeolier hæmmer væksten af forskellige humane kræftcellelinjer
- De virker kun specifikt på tumorceller og forringer ikke funktionen af normale celler
- EPA og DHA hæmmer væksten af humane cancercellelinjer og øger apoptose.
- Fiskeolie inducerer apoptose i humane kolorektale cancercellelinjer in vitro efter 48 timers inkubation
- Fiskeolie har vist sig at hæmme spredningsaktiviteterne, hæmme de invasive aktiviteter og øge apoptosen af humane pancreascarcinomcellelinjer in vitro efter kun 48 timers eksponering
- Fiskeolie har vist sig at øge kolorektale adenocarcinomcellelinjers følsomhed over for strålebehandling
- Fiskeolie har også vist sig at reducere forekomsten af levermetastaser i eksperimentelt induceret ductal pancreascancer hos rotter efter 30 ugers oral behandling med en omega-3 kosttilskud.
- Lungekræft xenotransplantater hos dyr fodret med fiskeolie viste signifikant øget tumorregression som respons på doxorubicin sammenlignet med dem, der blev fodret med omega-3.
Denne undersøgelse har til formål at vurdere effekten af omega-3 FA på levermetastaser i endetarm i et pilotstudie. 20 patienter vil blive udvalgt til dette pilotstudie med potentielt resekterbare hepatiske kolorektale adenokarcinommetastaser. 10 patienter vil modtage total parenteral ernæring (TPN) uden fiskeolier (kontroller), 10 vil modtage fiskeolie indeholdende lipidemulsion i deres TPN.
Ændringer i tumorangiogenese (øget angiogenese er forbundet med en dårligere prognose for levermetastaser i kolorektal) vil blive undersøgt ved hjælp af digital kontrastforstærket MRI-scanning, og markører for angiogenese vil blive undersøgt i blod og resekerede tumorprøver fra patienterne.
Det er et randomiseret kontrolleret dobbeltblindt forsøg.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
20
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Leicestershire
-
Leicester, Leicestershire, Det Forenede Kongerige, LE5 4PW
- Leicester General Hospital
-
-
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 til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inklusionskriterier:
- I alderen 18-80
- Kan give informeret skriftligt samtykke
- Diagnose af respektable hepatiske kolorektale metastaser på radiologiske og laparoskopiske udseende
Ekskluderingskriterier:
- Patienter, der allerede tager fiskeolietilskud
- Overfølsomhed over for fiske-, æg- eller sojaprotein eller over for et eller flere af de aktive stoffer eller bestanddele i lipidemulsionen
- Hyperlipidæmi
- Alvorlige blodkoagulationsforstyrrelser
- Alvorlig nyreinsufficiens (kreatinin >200)
- Generelle kontraindikationer til infusionsbehandling - lungeødem, hyperhydrering, dekompenseret hjerteinsufficiens
- Enhver ustabil medicinsk tilstand - ukontrolleret diabetes mellitus, akut myokardieinfarkt, slagtilfælde, embolisk sygdom, metabolisk acidose, sepsis, pancreatitis
- Patienter, der gennemgår konventionel neo-adjuverende kemoterapi.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Lipidem (fiskeolie)
Lipidem (TPN indeholdende fiskeolie)
|
|
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Aktiv komparator: Lipofundin (TPN)
Kontrolarm (ingen fiskeolie)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Ændring i gadoliniumchelatforstærkning på DCE-MRI mellem undersøgelsens start og exit, som bestemt ved at beregne den tovejs overførselskoefficient.(Ændringer i tumorangiogenese efter behandling med fiskeolier eller kontrol-TPN)
Tidsramme: 72 timer
|
72 timer
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Ændringer i biomarkører for inflammation og angiogenese i patientens blod og resekerede tumorprøver
Tidsramme: 14 dage
|
14 dage
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Ashley R Dennison, MBChB, FRCS, MD, Leicester General Hospital
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.
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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
1. maj 2007
Primær færdiggørelse (Faktiske)
1. december 2009
Studieafslutning (Faktiske)
1. oktober 2010
Datoer for studieregistrering
Først indsendt
16. juli 2009
Først indsendt, der opfyldte QC-kriterier
17. juli 2009
Først opslået (Skøn)
20. juli 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
25. juni 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. juni 2013
Sidst verificeret
1. juni 2013
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 10097 (Anden identifikator: Fred Hutch/University of Washington Cancer Consortium)
- REC reference: 06/Q2501/160
- EudraCT number: 2006-000044-71
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 .