- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00405678
Treningsintervensjonsstudie for tidlig stadium av brystkreftpasienter som mottar neoadjuvant terapi.
9. juli 2014 oppdatert av: Duke University
Effektene av trening på svulstvaskularitet og respons på neoadjuvant terapi ved operabel brystkreft: En fase I-II-studie
For å bestemme effekten av utholdenhetstrening på kardiopulmonal kondisjon hos brystkreftpasienter som gjennomgår neoadjuvant kjemoterapi.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Gitt at dette er den første studien som utforsker de potensielle effektene av treningstrening på treningskapasitet, svulstvaskularitet og respons hos kvinner som gjennomgår neoadjuvant kjemoterapi for operabel brystkreft, vil vi før igangsettingen av den fullstendige undersøkelsen gjennomføre en liten forkantstudie for å sikre at vi kan oppnå akseptable treningsoverholdelsesrater i fravær av dosebegrensende toksisiteter (DLT).
Spesifikt vil tre operable brystkreftpasienter rekrutteres og meldes inn som beskrevet nedenfor og utføre treningstrening i minimum seks uker.
Hvis akseptable treningshastigheter observeres i fravær av alvorlige DLT-er i løpet av denne tiden, vil vi fortsette med hele undersøkelsen (rekruttering av ytterligere 20 pasienter) (se figur 2).
Ved å bruke et prospektivt, randomisert design, vil potensielle deltakere bli identifisert og screenet for kvalifisering av en tildelt Breast Protocol Nurse (TBD) via journalgjennomgang av pasienter som er planlagt for deres primære neoadjuvante kjemoterapikonsultasjon ved DCCC
Studietype
Intervensjonell
Registrering (Faktiske)
23
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
North Carolina
-
Durham, North Carolina, Forente stater, 27710
- Duke University Medical Center
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inklusjonskriterier:
- Histologisk bekreftet operbar primær brystkreft
- Alder 18 eller eldre
- Karnofsky ytelsesstatus større enn 70
- Ingen tidligere malignitet
- Fravær av signifikant hjertesykdom (venstre ventrikkel ejeksjonsfraksjon større enn eller lik 50%)
- Ingen hormonell erstatningsterapi brukt den siste måneden
- Ikke gravid
- Evne til å lese og forstå engelsk
- Signert skriftlig informert samtykke før protokollspesifikke prosedyrer påbegynnes
- Villig til å reise til DUMC for å trene tre ganger i uken
- Godkjenning av primær behandlende onkolog
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 1
Forsøkspersoner som får cellegift og treningstrening
|
Forsøkspersoner som får cellegift med treningstrening
|
Eksperimentell: 2
Personer som kun får cellegift
|
Forsøkspersoner som får cellegift med treningstrening
Personer som kun får cellegift
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Bestem effekten av utholdenhetstrening på kardiopulmonal kondisjon via en stresstest
Tidsramme: 3 måneder
|
3 måneder
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Overholdelse av treningsprogram
Tidsramme: 3 måneder
|
3 måneder
|
Livskvalitet bestemt av (Functional Assessment of Cancer Therapy-Breast) FACT-B-skalaen.
Tidsramme: 3 måneder
|
3 måneder
|
Bestem og definer gjennomførbarhet for en tilstrekkelig drevet fase III-studie.
Tidsramme: 3 måneder
|
3 måneder
|
Bestem effekten av treningstrening på tumorvaskularitet, systemisk respons og tumorrespons.
Tidsramme: 3 måneder
|
3 måneder
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Lee W Jones, PhD, Duke University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
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- Stables GJ, Subar AF, Patterson BH, Dodd K, Heimendinger J, Van Duyn MA, Nebeling L. Changes in vegetable and fruit consumption and awareness among US adults: results of the 1991 and 1997 5 A Day for Better Health Program surveys. J Am Diet Assoc. 2002 Jun;102(6):809-17. doi: 10.1016/s0002-8223(02)90181-1.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2006
Primær fullføring (Faktiske)
1. februar 2010
Studiet fullført (Faktiske)
1. september 2010
Datoer for studieregistrering
Først innsendt
29. november 2006
Først innsendt som oppfylte QC-kriteriene
29. november 2006
Først lagt ut (Anslag)
30. november 2006
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
11. juli 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. juli 2014
Sist bekreftet
1. juli 2013
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Pro00007112
- 8426 (Duke legacy protocol number)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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