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Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial

13. oktober 2015 opdateret af: Joseph Roscoe

RATIONALE: Antiemetic drugs, such as granisetron, dexamethasone, prochlorperazine, aprepitant, and palonosetron, may help lessen or prevent nausea. It is not yet known which combination of antiemetic drugs is more effective in preventing nausea caused by chemotherapy.

PURPOSE: This randomized phase III trial is comparing different combinations of granisetron, dexamethasone, prochlorperazine, aprepitant, and palonosetron to see how well they work in preventing nausea in patients undergoing chemotherapy for breast cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • Compare the efficacy of palonosetron hydrochloride and dexamethasone followed by prochlorperazine with vs without dexamethasone in preventing delayed nausea in women with chemotherapy-naive breast cancer. (Arms I and IV)
  • Determine if palonosetron hydrochloride is more effective than granisetron hydrochloride in controlling treatment-related delayed nausea in these patients. (Arms I and II)
  • Determine if the currently recommended antiemetic guideline of aprepitant combined with palonosetron hydrochloride and dexamethasone is the most effective antiemetic regimen for controlling treatment-related delayed nausea in these patients. (Arms III and IV)

Secondary

  • Determine if the addition of dexamethasone to prochlorperazine is more effective than the same regimen without dexamethasone for reducing interference with functioning caused by chemotherapy-induced nausea and vomiting in these patients. (Arms I and IV)
  • Determine if palonosetron hydrochloride is more effective than granisetron hydrochloride for reducing interference with functioning caused by chemotherapy-induced nausea and vomiting in these patients. (Arms I and II)
  • Determine if the currently recommended antiemetic guideline of aprepitant combined with palonosetron hydrochloride and dexamethasone is the most effective antiemetic regimen for reducing interference with functioning due to chemotherapy-induced nausea and vomiting in these patients. (Arms III and IV)

OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to CCOP center and gender. Patients are randomized to 1 of 4 treatment arms. Patients receive study treatment approximately 30 minutes before their scheduled first chemotherapy treatment.

  • Arm I: Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
  • Arm II: Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
  • Arm III: Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.
  • Arm IV: Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.

Quality of life is assessed at baseline and on day 4. Nausea and vomiting, fatigue, sleep quality, exercise, and the need for rescue medication (metoclopramide) are assessed on days 1-4.

PROJECTED ACCRUAL: A total of 890 patients will be accrued for this study.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1021

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Mobile, Alabama, Forenede Stater, 36695
        • MBCCOP - Gulf Coast
    • Illinois
      • Decatur, Illinois, Forenede Stater, 62526
        • CCOP - Central Illinois
    • Kansas
      • Wichita, Kansas, Forenede Stater, 67214-3882
        • CCOP - Wichita
    • Michigan
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • CCOP - Grand Rapids
      • Kalamazoo, Michigan, Forenede Stater, 49007-3731
        • CCOP - Kalamazoo
    • Minnesota
      • St. Louis Park, Minnesota, Forenede Stater, 55416
        • CCOP - Metro-Minnesota
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64131
        • CCOP - Kansas City
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89106
        • CCOP - Nevada Cancer Research Foundation
    • New York
      • East Syracuse, New York, Forenede Stater, 13057
        • CCOP - Hematology-Oncology Associates of Central New York
      • Manhassett, New York, Forenede Stater, 11030
        • CCOP - North Shore University Hospital
    • North Carolina
      • Goldsboro, North Carolina, Forenede Stater, 27534-9479
        • CCOP - Southeast Cancer Control Consortium
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43215
        • CCOP - Columbus
      • Dayton, Ohio, Forenede Stater, 45429
        • CCOP - Dayton
    • South Carolina
      • Greenville, South Carolina, Forenede Stater, 29615
        • CCOP - Greenville
    • Washington
      • Tacoma, Washington, Forenede Stater, 98405-0986
        • CCOP - Northwest
    • Wisconsin
      • Marshfield, Wisconsin, Forenede Stater, 54449
        • CCOP - Marshfield Clinic Research Foundation

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

Beskrivelse

Inclusion criteria:

  • Have a diagnosis of cancer and be chemotherapy naive.
  • Must be scheduled to receive a chemotherapy treatment containing doxorubicin hydrochloride, epirubicin hydrochloride, cisplatin, carboplatin, or oxaliplatin (any dose or schedule) without concurrent radiotherapy or interferon treatment
  • Chemotherapy may be for adjuvant, neoadjuvant, curative or palliative intent.
  • Dose-dense regimens (e.g. chemotherapy with doxorubicin or epirubicin given every two weeks)are allowed.
  • For the purposes of this study, Day 1 of chemotherapy will be defined as the day of administration of cisplatin, carboplatin, oxaliplatin, doxorubicin or epirubicin.
  • Regimens with multiple-day doses of doxorubicin, epirubicin, cisplatin, carboplatin, oxaliplatin, dacarbazine, hexamethylmelamine, nitrosoureas, or streptozocin are not allowed. Chemotherapy agents, other than those listed above, may be given orally, intravenously, or by continuous infusion on one or multiple days.
  • Able to understand English

Exclusion criteria:

  • No symptomatic brain metastases
  • No concurrent or impending bowel obstruction
  • Regimens containing liposomal doxorubicin or cisplatin are not allowed.
  • No concurrent pimozide, terfenadine, astemizole, or cisapride
  • No concurrent doxorubicin hydrochloride liposome or cisplatin
  • No concurrent multiple-day doses of dacarbazine, altretamine, nitrosoureas, streptozocin, cisplatin, carboplatin, or oxaliplatin

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Arm I
Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
Medicin: placebo
Gives oralt
Medicin: dexamethason
Gives oralt eller IV
Andre navne:
  • Dekadron
Medicin: palonosetron hydrochloride
Given orally or IV
Andre navne:
  • Aloxi
Medicin: prochlorperazine
Given orally or IV
Andre navne:
  • Compazine
Eksperimentel: Arm II
Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
Medicin: placebo
Gives oralt
Medicin: dexamethason
Gives oralt eller IV
Andre navne:
  • Dekadron
Medicin: prochlorperazine
Given orally or IV
Andre navne:
  • Compazine
Medicin: granisetron hydrochloride
Given orally or IV
Andre navne:
  • Kytril
Aktiv komparator: Arm III
Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.
Medicin: placebo
Gives oralt
Medicin: dexamethason
Gives oralt eller IV
Andre navne:
  • Dekadron
Medicin: palonosetron hydrochloride
Given orally or IV
Andre navne:
  • Aloxi
Medicin: aprepitant
Given orally or IV
Andre navne:
  • Emend
Eksperimentel: Arm IV
Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.
Medicin: placebo
Gives oralt
Medicin: dexamethason
Gives oralt eller IV
Andre navne:
  • Dekadron
Medicin: palonosetron hydrochloride
Given orally or IV
Andre navne:
  • Aloxi
Medicin: prochlorperazine
Given orally or IV
Andre navne:
  • Compazine

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Home Record: Severity of Delayed Nausea
Tidsramme: average of day 1 afternoon, evening and night, and all of days 2 and 3
1=not at all nauseated to 7=extremely nauseated, therefore higher values are worse
average of day 1 afternoon, evening and night, and all of days 2 and 3

Samarbejdspartnere og efterforskere

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

Sponsor

Joseph Roscoe

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Joseph A. Roscoe, PhD, James P. Wilmot Cancer Center

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

1. december 2006

Primær færdiggørelse (Faktiske)

1. december 2012

Datoer for studieregistrering

Først indsendt

16. maj 2007

Først indsendt, der opfyldte QC-kriterier

16. maj 2007

Først opslået (Skøn)

17. maj 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. november 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. oktober 2015

Sidst verificeret

1. oktober 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000544841
  • U10CA037420 (U.S. NIH-bevilling/kontrakt)
  • URCC-U1105 (Anden identifikator: University of Rochester)

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 .

Kliniske forsøg med placebo

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Pakistan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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