Brugen af kryoterapi til at forhindre paclitaxel-induceret perifer neuropati og negleforandringer hos kvinder med brystkræft
4. marts 2021 opdateret af: Danielle Payne, Parkview Health
Denne undersøgelse vil bestemme effektiviteten af kryoterapi til at forhindre paclitaxel-induceret perifer neuropati og negleforandringer hos kvinder med brystkræft.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Kvinder med brystkræft, der får paclitaxel, vil gennemføre Brief Pain Inventory (BPI), Neuropathic Pain Syndrome Inventory (NPSI), mens et medlem af forskerholdet vil foretage en vurdering af deres negle. Når den er afsluttet, vil kryoterapi blive administreret 15 minutter før paclitaxel-infusionen, kontinuerligt under og derefter 15 minutter efter afslutning af paclitaxel i i alt 90 minutter. Cyroterapi vil blive leveret med Elasto-gel luffer og Rapid relief hjemmesko. Disse elementer vil blive ændret 45 minutter efter påbegyndelse for at sikre kulde.
Der vil være to arme af undersøgelsen. Den ene arm vil omfatte forsøgspersoner, som vil bære en tøffel/en lute på deres fod/hånd, mens den anden fod/hånd vil tjene som kontrol. Den anden arm vil omfatte forsøgspersoner, der skal have kryoterapi til både hænder og fødder. . Denne proces vil blive gentaget i alt 12 gange i forbindelse med 12 doser paclitaxel. På tidspunkt 13, under et rutinebesøg hos deres onkolog, vil forsøgspersonernes negle blive revurderet sammen med fuldførelse af BPI og NPSIA i alt 25 forsøgspersoner vil blive tilmeldt hver arm.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
14
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Indiana
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Fort Wayne, Indiana, Forenede Stater, 46845
- Parkview Cancer Institute
-
-
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
14 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inklusionskriterier:
- Kvinder 18 år eller ældre
- Histologisk bekræftet diagnose af brystkræft
- Modtagelse af neo-adjuverende eller adjuverende dosistæt anthracyclin (AC) plus taxan-baseret kemoterapi eller paclitaxel i kombination med trastuzumab og pertuzumab
Ekskluderingskriterier:
- Tidligere taxanbehandling
- Tidligere behandling med oxaliplatin
- Ikke-engelsktalende
- Anamnese med perifer neuropati, dvs. Buergers sygdom
- Historie om diabetes mellitus
- Eksisterende perifer neuropati fra andre tilstande, f.eks. Raynauds sygdom, Guillain-Barre, Miller Fishers syndrom
- Hånd-, negle- eller fodtilstande, f.eks. hånd-/fodsyndrom, gigt, hammertå, karpaltunnel, knyster, deformiteter
- Alkoholmisbrug (historie/aktuel)
- Nuværende medicinbrug af opioider, anti-depressiva, anti-konvulsiva, glutaminer, vitamin B12
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Interventionkryoterapi/kontrol
Forsøgspersonerne vil have en vante/en tøffel og tjene som deres egen kontrol
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kryoterapi vil blive leveret
|
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Ingen indgriben: plejestandard
Forsøgspersonerne vil have to luffer/tøfler
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Følelsesløshed, prikken, smerte, negletoksicitet
Tidsramme: 13 uger
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fravær af følelsesløshed og prikken i de behandlede hænder/fødder
|
13 uger
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Danielle R Payne, MSN, Parkview Health
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
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- LaPointe NE, Morfini G, Brady ST, Feinstein SC, Wilson L, Jordan MA. Effects of eribulin, vincristine, paclitaxel and ixabepilone on fast axonal transport and kinesin-1 driven microtubule gliding: implications for chemotherapy-induced peripheral neuropathy. Neurotoxicology. 2013 Jul;37:231-9. doi: 10.1016/j.neuro.2013.05.008. Epub 2013 May 24.
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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 (Faktiske)
4. august 2020
Primær færdiggørelse (Faktiske)
3. februar 2021
Studieafslutning (Faktiske)
3. februar 2021
Datoer for studieregistrering
Først indsendt
3. september 2020
Først indsendt, der opfyldte QC-kriterier
15. september 2020
Først opslået (Faktiske)
22. september 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. marts 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. marts 2021
Sidst verificeret
1. marts 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NUR20-0124CRYO
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- Formular til informeret samtykke (ICF)
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- Analytisk kode
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