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Bupropion for å redusere kreftrelatert tretthet i stadium I-III brystkreftoverlevende

14. januar 2026 oppdatert av: Luke Peppone, University of Rochester NCORP Research Base

Randomisert placebokontrollert studie av bupropion for kreftrelatert tretthet

Denne fase III-studien studerer hvor godt bupropion virker for å redusere kreftrelatert tretthet hos overlevende av brystkreft i stadium I-III. Bupropion er et medikament som brukes til å behandle depresjon, samt for å hjelpe folk å slutte å røyke. Kreft og dens behandling kan forårsake tretthet. Å gi bupropion kan forbedre kreftrelatert tretthet hos brystkreftoverlevere.

Studieoversikt

Detaljert beskrivelse

PRIMÆRE MÅL:

I. For å bestemme effekten av bupropionhydroklorid kontrollert frigjøring (bupropion) versus placebo for å redusere tretthet i en dobbeltblindet, placebokontrollert, randomisert klinisk studie av brystkreftoverlevere med tretthet.

SEKUNDÆRE MÅL:

I. For å vurdere effekten av bupropion versus placebo på depresjon og livskvalitet hos brystkreftoverlevere med tretthet.

II. For å vurdere tolerabiliteten av bupropion hos brystkreftoverlevere med tretthet.

UNDERSØKENDE MÅL:

I. Å vurdere effekten av bupropion versus placebo på symptomatologi og kognisjon hos brystkreftoverlevere med tretthet.

II. Å utforske effekten av bupropion på antatte mekanismer for kreftrelatert tretthet.

III. Å utforske assosiasjoner til CYP2B6-genotype med bupropionmetabolisme og endringer i tretthet.

OVERSIGT: Pasienter randomiseres til 1 av 2 armer.

ARM I: Pasienter får bupropionhydroklorid kontrollert frigjøring oralt (PO) én gang daglig (QD) i opptil 13 uker i fravær av uakseptabel toksisitet.

ARM II: Pasienter får placebo PO QD i opptil 13 uker i fravær av uakseptabel toksisitet.

Studietype

Intervensjonell

Registrering (Antatt)

422

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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        • Huron Gastroenterology PC
    • Minnesota
      • Burnsville, Minnesota, Forente stater, 55337
        • Fairview Ridges Hospital
      • Burnsville, Minnesota, Forente stater, 55337
        • Minnesota Oncology - Burnsville
      • Cambridge, Minnesota, Forente stater, 55008
        • Cambridge Medical Center
      • Coon Rapids, Minnesota, Forente stater, 55433
        • Mercy Hospital
      • Edina, Minnesota, Forente stater, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, Forente stater, 55432
        • Unity Hospital
      • Maple Grove, Minnesota, Forente stater, 55369
        • Fairview Clinics and Surgery Center Maple Grove
      • Maplewood, Minnesota, Forente stater, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, Forente stater, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, Forente stater, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, Forente stater, 55407
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, Forente stater, 55454
        • Health Partners Inc
      • Monticello, Minnesota, Forente stater, 55362
        • Monticello Cancer Center
      • New Ulm, Minnesota, Forente stater, 56073
        • New Ulm Medical Center
      • Princeton, Minnesota, Forente stater, 55371
        • Fairview Northland Medical Center
      • Robbinsdale, Minnesota, Forente stater, 55422
        • North Memorial Medical Health Center
      • Saint Louis Park, Minnesota, Forente stater, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, Forente stater, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, Forente stater, 55102
        • United Hospital
      • Shakopee, Minnesota, Forente stater, 55379
        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, Forente stater, 55082
        • Lakeview Hospital
      • Waconia, Minnesota, Forente stater, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, Forente stater, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, Forente stater, 55125
        • Minnesota Oncology Hematology PA-Woodbury
      • Wyoming, Minnesota, Forente stater, 55092
        • Fairview Lakes Medical Center
    • Mississippi
      • Gulfport, Mississippi, Forente stater, 39502
        • Gulfport Memorial Hospital
    • Missouri
      • Ballwin, Missouri, Forente stater, 63011
        • Saint Louis Cancer and Breast Institute-Ballwin
      • Bolivar, Missouri, Forente stater, 65613
        • Central Care Cancer Center - Bolivar
      • Bonne Terre, Missouri, Forente stater, 63628
        • Parkland Health Center-Bonne Terre
      • Branson, Missouri, Forente stater, 65616
        • Cox Cancer Center Branson
      • Cape Girardeau, Missouri, Forente stater, 63703
        • Saint Francis Medical Center
      • Cape Girardeau, Missouri, Forente stater, 63703
        • Mercy Cancer Center - Cape Girardeau
      • Farmington, Missouri, Forente stater, 63640
        • Parkland Health Center - Farmington
      • Independence, Missouri, Forente stater, 64057
        • Centerpoint Medical Center LLC
      • Jefferson City, Missouri, Forente stater, 65109
        • MU Health Care Goldschmidt Cancer Center
      • Joplin, Missouri, Forente stater, 64804
        • Freeman Health System
      • Joplin, Missouri, Forente stater, 64804
        • Mercy Hospital Joplin
      • Kansas City, Missouri, Forente stater, 64132
        • Research Medical Center
      • Osage Beach, Missouri, Forente stater, 65065
        • Lake Regional Hospital
      • Rolla, Missouri, Forente stater, 65401
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Rolla, Missouri, Forente stater, 65401
        • Phelps Health Delbert Day Cancer Institute
      • Saint Joseph, Missouri, Forente stater, 64506
        • Heartland Regional Medical Center
      • Sainte Genevieve, Missouri, Forente stater, 63670
        • Sainte Genevieve County Memorial Hospital
      • Springfield, Missouri, Forente stater, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, Forente stater, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, Forente stater, 63131
        • Missouri Baptist Medical Center
      • St Louis, Missouri, Forente stater, 63141
        • Mercy Hospital Saint Louis
      • St Louis, Missouri, Forente stater, 63128
        • Mercy Hospital South
      • St Louis, Missouri, Forente stater, 63109
        • Saint Louis Cancer and Breast Institute-South City
      • Sullivan, Missouri, Forente stater, 63080
        • Missouri Baptist Sullivan Hospital
      • Sunset Hills, Missouri, Forente stater, 63127
        • BJC Outpatient Center at Sunset Hills
      • Washington, Missouri, Forente stater, 63090
        • Mercy Hospital Washington
    • Montana
      • Missoula, Montana, Forente stater, 59802
        • Saint Patrick Hospital - Community Hospital
    • Nevada
      • Carson City, Nevada, Forente stater, 89703
        • Carson Tahoe Regional Medical Center
      • Henderson, Nevada, Forente stater, 89052
        • Comprehensive Cancer Centers of Nevada - Henderson
      • Henderson, Nevada, Forente stater, 89052
        • OptumCare Cancer Care at Seven Hills
      • Henderson, Nevada, Forente stater, 89052
        • Cancer and Blood Specialists-Henderson
      • Henderson, Nevada, Forente stater, 89052
        • Las Vegas Cancer Center-Henderson
      • Henderson, Nevada, Forente stater, 89074
        • Comprehensive Cancer Centers of Nevada-Southeast Henderson
      • Henderson, Nevada, Forente stater, 89074
        • GenesisCare USA - Henderson
      • Henderson, Nevada, Forente stater, 89052
        • Comprehensive Cancer Centers of Nevada-Horizon Ridge
      • Henderson, Nevada, Forente stater, 89074
        • Las Vegas Urology - Green Valley
      • Henderson, Nevada, Forente stater, 89074
        • Las Vegas Urology - Pebble
      • Henderson, Nevada, Forente stater, 89074
        • Urology Specialists of Nevada - Green Valley
      • Las Vegas, Nevada, Forente stater, 89144
        • Summerlin Hospital Medical Center
      • Las Vegas, Nevada, Forente stater, 89109
        • Sunrise Hospital and Medical Center
      • Las Vegas, Nevada, Forente stater, 89102
        • OptumCare Cancer Care at Charleston
      • Las Vegas, Nevada, Forente stater, 89106
        • Radiation Oncology Centers of Nevada Central
      • Las Vegas, Nevada, Forente stater, 89109
        • GenesisCare USA - Las Vegas
      • Las Vegas, Nevada, Forente stater, 89119
        • Radiation Oncology Centers of Nevada Southeast
      • Las Vegas, Nevada, Forente stater, 89128
        • Comprehensive Cancer Centers of Nevada - Northwest
      • Las Vegas, Nevada, Forente stater, 89128
        • OptumCare Cancer Care at MountainView
      • Las Vegas, Nevada, Forente stater, 89135
        • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
      • Las Vegas, Nevada, Forente stater, 89144
        • Comprehensive Cancer Centers of Nevada - Town Center
      • Las Vegas, Nevada, Forente stater, 89144
        • Comprehensive Cancer Centers of Nevada-Summerlin
      • Las Vegas, Nevada, Forente stater, 89148
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, Forente stater, 89148
        • OptumCare Cancer Care at Fort Apache
      • Las Vegas, Nevada, Forente stater, 89169
        • Comprehensive Cancer Centers of Nevada - Central Valley
      • Las Vegas, Nevada, Forente stater, 89102
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, Forente stater, 89106
        • Cancer and Blood Specialists-Shadow
      • Las Vegas, Nevada, Forente stater, 89109
        • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
      • Las Vegas, Nevada, Forente stater, 89113
        • HealthCare Partners Medical Group Oncology/Hematology-San Martin
      • Las Vegas, Nevada, Forente stater, 89128
        • Cancer and Blood Specialists-Tenaya
      • Las Vegas, Nevada, Forente stater, 89128
        • GenesisCare USA - Vegas Tenaya
      • Las Vegas, Nevada, Forente stater, 89128
        • HealthCare Partners Medical Group Oncology/Hematology-Tenaya
      • Las Vegas, Nevada, Forente stater, 89148-2405
        • Las Vegas Cancer Center-Medical Center
      • Las Vegas, Nevada, Forente stater, 89148
        • GenesisCare USA - Fort Apache
      • Las Vegas, Nevada, Forente stater, 89149
        • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
      • Las Vegas, Nevada, Forente stater, 89128
        • Ann M Wierman MD LTD
      • Las Vegas, Nevada, Forente stater, 89074
        • Las Vegas Urology - Pecos
      • Las Vegas, Nevada, Forente stater, 89102
        • Desert West Surgery
      • Las Vegas, Nevada, Forente stater, 89103
        • Hope Cancer Care of Nevada
      • Las Vegas, Nevada, Forente stater, 89106
        • Urology Specialists of Nevada - Central
      • Las Vegas, Nevada, Forente stater, 89113
        • Las Vegas Prostate Cancer Center
      • Las Vegas, Nevada, Forente stater, 89113
        • Las Vegas Urology - Sunset
      • Las Vegas, Nevada, Forente stater, 89128
        • Las Vegas Urology - Cathedral Rock
      • Las Vegas, Nevada, Forente stater, 89128
        • Las Vegas Urology - Smoke Ranch
      • Las Vegas, Nevada, Forente stater, 89128
        • Urology Specialists of Nevada - Northwest
      • Las Vegas, Nevada, Forente stater, 89169
        • University Cancer Center
      • Las Vegas, Nevada, Forente stater, 89113
        • Urology Specialists of Nevada - Southwest
      • Pahrump, Nevada, Forente stater, 89048
        • Hope Cancer Care of Nevada-Pahrump
      • Reno, Nevada, Forente stater, 89502
        • Renown Regional Medical Center
      • Reno, Nevada, Forente stater, 89503
        • Saint Mary's Regional Medical Center
      • Reno, Nevada, Forente stater, 89509
        • Radiation Oncology Associates
    • New York
      • Greenlawn, New York, Forente stater, 11740
        • Northwell Health Cancer Institute at Huntington
      • Lake Success, New York, Forente stater, 11042
        • Northwell Health/Center for Advanced Medicine
    • North Carolina
      • Asheboro, North Carolina, Forente stater, 27203
        • Randolph Hospital
      • Asheboro, North Carolina, Forente stater, 27203
        • Cone Health Cancer Center at Asheboro
      • Asheboro, North Carolina, Forente stater, 27205
        • Cone Health MedCenter Asheboro
      • Burlington, North Carolina, Forente stater, 27215
        • Cone Health Cancer Center at Alamance Regional
      • Gastonia, North Carolina, Forente stater, 28054
        • CaroMont Regional Medical Center
      • Greensboro, North Carolina, Forente stater, 27403
        • Cone Health Cancer Center
      • Greensboro, North Carolina, Forente stater, 27410
        • Cone Health Cancer Center at Drawbridge Parkway
      • Greensboro, North Carolina, Forente stater, 27403
        • Novant Health Breast Surgery - Greensboro
      • Hendersonville, North Carolina, Forente stater, 28791
        • Margaret R Pardee Memorial Hospital
      • Kernersville, North Carolina, Forente stater, 27284
        • Novant Health Cancer Institute - Kernersville
      • Mount Airy, North Carolina, Forente stater, 27030
        • Novant Health Cancer Institute - Mount Airy
      • Nags Head, North Carolina, Forente stater, 27959
        • Outer Banks Hospital
      • North Wilkesboro, North Carolina, Forente stater, 28659
        • Novant Health Cancer Institute - Wilkesboro
      • Reidsville, North Carolina, Forente stater, 27320
        • Annie Penn Memorial Hospital
      • Stateville, North Carolina, Forente stater, 28625
        • Novant Health Cancer Institute - Statesville
      • Thomasville, North Carolina, Forente stater, 27360
        • Novant Health Cancer Institute - Thomasville
      • Winston-Salem, North Carolina, Forente stater, 27103
        • Novant Health Forsyth Medical Center
    • Ohio
      • Beavercreek, Ohio, Forente stater, 45431
        • Indu and Raj Soin Medical Center
      • Belpre, Ohio, Forente stater, 45714
        • Strecker Cancer Center-Belpre
      • Boardman, Ohio, Forente stater, 44512
        • Saint Elizabeth Boardman Hospital
      • Centerville, Ohio, Forente stater, 45459
        • Miami Valley Hospital South
      • Centerville, Ohio, Forente stater, 45459
        • Dayton Physicians LLC-Miami Valley South
      • Chillicothe, Ohio, Forente stater, 45601
        • Adena Regional Medical Center
      • Cincinnati, Ohio, Forente stater, 45236
        • Oncology Hematology Care Inc-Kenwood
      • Columbus, Ohio, Forente stater, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, Forente stater, 43219
        • The Mark H Zangmeister Center
      • Columbus, Ohio, Forente stater, 43214
        • Columbus Oncology and Hematology Associates Inc
      • Columbus, Ohio, Forente stater, 43228
        • Doctors Hospital
      • Columbus, Ohio, Forente stater, 43213
        • Mount Carmel East Hospital
      • Columbus, Ohio, Forente stater, 43215
        • Grant Medical Center
      • Columbus, Ohio, Forente stater, 43222
        • Mount Carmel Health Center West
      • Dayton, Ohio, Forente stater, 45406
        • Good Samaritan Hospital - Dayton
      • Dayton, Ohio, Forente stater, 45409
        • Miami Valley Hospital
      • Dayton, Ohio, Forente stater, 45415
        • Miami Valley Hospital North
      • Dayton, Ohio, Forente stater, 45415
        • Dayton Physician LLC - Englewood
      • Delaware, Ohio, Forente stater, 43015
        • Delaware Health Center-Grady Cancer Center
      • Delaware, Ohio, Forente stater, 43015
        • Grady Memorial Hospital
      • Dublin, Ohio, Forente stater, 43016
        • Dublin Methodist Hospital
      • Dublin, Ohio, Forente stater, 43016
        • Columbus Oncology and Hematology Associates
      • Findlay, Ohio, Forente stater, 45840
        • Blanchard Valley Hospital
      • Findlay, Ohio, Forente stater, 45840
        • Armes Family Cancer Center
      • Findlay, Ohio, Forente stater, 45840
        • Orion Cancer Care
      • Franklin, Ohio, Forente stater, 45005-1066
        • Atrium Medical Center-Middletown Regional Hospital
      • Franklin, Ohio, Forente stater, 45005
        • Dayton Physicians LLC-Atrium
      • Gahanna, Ohio, Forente stater, 43230
        • Central Ohio Breast and Endocrine Surgery
      • Greenville, Ohio, Forente stater, 45331
        • Wayne Hospital
      • Greenville, Ohio, Forente stater, 45331
        • Dayton Physicians LLC-Wayne
      • Grove City, Ohio, Forente stater, 43123
        • Mount Carmel Grove City Hospital
      • Grove City, Ohio, Forente stater, 43123
        • Zangmeister Center Grove City
      • Kettering, Ohio, Forente stater, 45429
        • Kettering Medical Center
      • Kettering, Ohio, Forente stater, 45409
        • Greater Dayton Cancer Center
      • Kettering, Ohio, Forente stater, 45420
        • First Dayton Cancer Care
      • Lancaster, Ohio, Forente stater, 43130
        • Fairfield Medical Center
      • Lima, Ohio, Forente stater, 45801
        • Saint Rita's Medical Center
      • Mansfield, Ohio, Forente stater, 44903
        • OhioHealth Mansfield Hospital
      • Marietta, Ohio, Forente stater, 45750
        • Marietta Memorial Hospital
      • Marion, Ohio, Forente stater, 43302
        • OhioHealth Marion General Hospital
      • Marysville, Ohio, Forente stater, 43040
        • Memorial Hospital
      • Mount Vernon, Ohio, Forente stater, 43050
        • Knox Community Hospital
      • New Albany, Ohio, Forente stater, 43054
        • Mount Carmel New Albany Surgical Hospital
      • Newark, Ohio, Forente stater, 43055
        • Licking Memorial Hospital
      • Newark, Ohio, Forente stater, 43055
        • Newark Radiation Oncology
      • Perrysburg, Ohio, Forente stater, 43551
        • Mercy Health - Perrysburg Hospital
      • Portsmouth, Ohio, Forente stater, 45662
        • Southern Ohio Medical Center
      • Springfield, Ohio, Forente stater, 45504
        • Springfield Regional Cancer Center
      • Springfield, Ohio, Forente stater, 45504
        • Springfield Regional Medical Center
      • Toledo, Ohio, Forente stater, 43623
        • Mercy Health - Saint Anne Hospital
      • Toledo, Ohio, Forente stater, 43608
        • Mercy Health - Saint Vincent Hospital
      • Toledo, Ohio, Forente stater, 43623
        • Mercy Health Sylvania Radiation Oncology Center
      • Troy, Ohio, Forente stater, 45373
        • Upper Valley Medical Center
      • Troy, Ohio, Forente stater, 45373
        • Dayton Physicians LLC - Troy
      • Warren, Ohio, Forente stater, 44484
        • Saint Joseph Warren Hospital
      • Westerville, Ohio, Forente stater, 43081
        • Saint Ann's Hospital
      • Wilmington, Ohio, Forente stater, 45177
        • Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center
      • Wpafb, Ohio, Forente stater, 45433
        • Wright-Patterson Medical Center
      • Youngstown, Ohio, Forente stater, 44501
        • Saint Elizabeth Youngstown Hospital
      • Zanesville, Ohio, Forente stater, 43701
        • Genesis Healthcare System Cancer Care Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73120
        • Mercy Hospital Oklahoma City
    • Oregon
      • Bend, Oregon, Forente stater, 97701
        • Saint Charles Health System
      • Clackamas, Oregon, Forente stater, 97015
        • Clackamas Radiation Oncology Center
      • Clackamas, Oregon, Forente stater, 97015
        • Providence Cancer Institute Clackamas Clinic
      • Coos Bay, Oregon, Forente stater, 97420
        • Bay Area Hospital
      • Newberg, Oregon, Forente stater, 97132
        • Providence Newberg Medical Center
      • Oregon City, Oregon, Forente stater, 97045
        • Providence Willamette Falls Medical Center
      • Portland, Oregon, Forente stater, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, Forente stater, 97225
        • Providence Saint Vincent Medical Center
      • Redmond, Oregon, Forente stater, 97756
        • Saint Charles Health System-Redmond
    • Pennsylvania
      • Allentown, Pennsylvania, Forente stater, 18103
        • Lehigh Valley Hospital-Cedar Crest
      • Bethlehem, Pennsylvania, Forente stater, 18017
        • Lehigh Valley Hospital - Muhlenberg
      • Chadds Ford, Pennsylvania, Forente stater, 19317
        • Christiana Care Health System-Concord Health Center
      • Danville, Pennsylvania, Forente stater, 17822
        • Geisinger Medical Center
      • East Stroudsburg, Pennsylvania, Forente stater, 18301
        • Pocono Medical Center
      • Hazleton, Pennsylvania, Forente stater, 18201
        • Geisinger Medical Center-Cancer Center Hazleton
      • Hazleton, Pennsylvania, Forente stater, 18201
        • Lehigh Valley Hospital-Hazleton
      • Lewisburg, Pennsylvania, Forente stater, 17837
        • Geisinger Medical Oncology-Lewisburg
      • Lewistown, Pennsylvania, Forente stater, 17044
        • Lewistown Hospital
      • Pottsville, Pennsylvania, Forente stater, 17901
        • Geisinger Cancer Services-Pottsville
      • Scranton, Pennsylvania, Forente stater, 18510
        • Community Medical Center
      • Selinsgrove, Pennsylvania, Forente stater, 17870
        • Geisinger Medical Oncology-Selinsgrove
      • State College, Pennsylvania, Forente stater, 16801
        • Geisinger Medical Group
      • Wilkes-Barre, Pennsylvania, Forente stater, 18711
        • Geisinger Wyoming Valley/Henry Cancer Center
    • South Carolina
      • Bluffton, South Carolina, Forente stater, 29910
        • Saint Joseph's/Candler - Bluffton Campus
      • Boiling Springs, South Carolina, Forente stater, 29316
        • Prisma Health Cancer Institute - Spartanburg
      • Easley, South Carolina, Forente stater, 29640
        • Prisma Health Cancer Institute - Easley
      • Gaffney, South Carolina, Forente stater, 29341
        • Gibbs Cancer Center-Gaffney
      • Greenville, South Carolina, Forente stater, 29605
        • Prisma Health Cancer Institute - Faris
      • Greenville, South Carolina, Forente stater, 29607
        • Saint Francis Cancer Center
      • Greenville, South Carolina, Forente stater, 29615
        • Prisma Health Cancer Institute - Eastside
      • Greenville, South Carolina, Forente stater, 29605
        • Prisma Health Cancer Institute - Butternut
      • Greenville, South Carolina, Forente stater, 29601
        • Saint Francis Hospital
      • Greenville, South Carolina, Forente stater, 29605
        • Prisma Health Greenville Memorial Hospital
      • Greer, South Carolina, Forente stater, 29650
        • Prisma Health Cancer Institute - Greer
      • Greer, South Carolina, Forente stater, 29651
        • Gibbs Cancer Center-Pelham
      • Hilton Head Island, South Carolina, Forente stater, 29926-3827
        • South Carolina Cancer Specialists PC
      • Seneca, South Carolina, Forente stater, 29672
        • Prisma Health Cancer Institute - Seneca
      • Spartanburg, South Carolina, Forente stater, 29303
        • Spartanburg Medical Center
      • Spartanburg, South Carolina, Forente stater, 29307
        • Spartanburg Medical Center - Mary Black Campus
      • Spartanburg, South Carolina, Forente stater, 29303
        • North Grove Medical Park
      • Union, South Carolina, Forente stater, 29379
        • SMC Center for Hematology Oncology Union
    • Tennessee
      • Cookeville, Tennessee, Forente stater, 38501
        • Cookeville Regional Medical Center
    • Virginia
      • Chesapeake, Virginia, Forente stater, 23320
        • Chesapeake Regional Medical Center
      • Martinsville, Virginia, Forente stater, 24112
        • Sovah Health Martinsville
      • Mechanicsville, Virginia, Forente stater, 23116
        • Bon Secours Memorial Regional Medical Center
      • Midlothian, Virginia, Forente stater, 23114
        • Bon Secours Saint Francis Medical Center
      • Midlothian, Virginia, Forente stater, 23113
        • Bon Secours Westchester Emergency Center
      • Norfolk, Virginia, Forente stater, 23505
        • Bon Secours DePaul Medical Center
      • Portsmouth, Virginia, Forente stater, 23707
        • Bon Secours Maryview Medical Center
      • Richmond, Virginia, Forente stater, 23226
        • Bon Secours Saint Mary's Hospital
      • Richmond, Virginia, Forente stater, 23230
        • Bon Secours Cancer Institute at Reynolds Crossing
      • Richmond, Virginia, Forente stater, 23223
        • Bon Secours Richmond Community Hospital
      • Suffolk, Virginia, Forente stater, 23435
        • Bon Secours Health Center at Harbour View
    • Washington
      • Aberdeen, Washington, Forente stater, 98520
        • Providence Regional Cancer System-Aberdeen
      • Bellevue, Washington, Forente stater, 98004
        • Overlake Medical Center
      • Bellingham, Washington, Forente stater, 98225
        • PeaceHealth Saint Joseph Medical Center
      • Centralia, Washington, Forente stater, 98531
        • Providence Regional Cancer System-Centralia
      • Edmonds, Washington, Forente stater, 98026
        • Swedish Cancer Institute-Edmonds
      • Everett, Washington, Forente stater, 98201
        • Providence Regional Cancer Partnership
      • Issaquah, Washington, Forente stater, 98029
        • Swedish Cancer Institute-Issaquah
      • Kennewick, Washington, Forente stater, 99336
        • Kadlec Clinic Hematology and Oncology
      • Lacey, Washington, Forente stater, 98503
        • Providence Regional Cancer System-Lacey
      • Longview, Washington, Forente stater, 98632
        • PeaceHealth Saint John Medical Center
      • Mount Vernon, Washington, Forente stater, 98274
        • Skagit Regional Health Cancer Care Center
      • Port Townsend, Washington, Forente stater, 98368
        • Jefferson Healthcare
      • Renton, Washington, Forente stater, 98055
        • Valley Medical Center
      • Seattle, Washington, Forente stater, 98107
        • Swedish Medical Center-Ballard Campus
      • Seattle, Washington, Forente stater, 98122
        • Swedish Medical Center-First Hill
      • Seattle, Washington, Forente stater, 98104
        • Pacific Gynecology Specialists
      • Seattle, Washington, Forente stater, 98122-5711
        • Swedish Medical Center-Cherry Hill
      • Sedro-Woolley, Washington, Forente stater, 98284
        • PeaceHealth United General Medical Center
      • Shelton, Washington, Forente stater, 98584
        • Providence Regional Cancer System-Shelton
      • Vancouver, Washington, Forente stater, 98664
        • PeaceHealth Southwest Medical Center
      • Walla Walla, Washington, Forente stater, 99362
        • Providence Saint Mary Regional Cancer Center
      • Yakima, Washington, Forente stater, 98902
        • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
      • Yelm, Washington, Forente stater, 98597
        • Providence Regional Cancer System-Yelm
    • Wisconsin
      • Antigo, Wisconsin, Forente stater, 54409
        • Langlade Hospital and Cancer Center
      • Appleton, Wisconsin, Forente stater, 54911
        • ThedaCare Regional Cancer Center
      • Appleton, Wisconsin, Forente stater, 54915
        • Ascension Saint Elizabeth Hospital
      • Brookfield, Wisconsin, Forente stater, 53045
        • Ascension Southeast Wisconsin Hospital - Elmbrook Campus
      • Chilton, Wisconsin, Forente stater, 53014
        • Ascension Calumet Hospital
      • Eau Claire, Wisconsin, Forente stater, 54701
        • Marshfield Medical Center-EC Cancer Center
      • Eau Claire, Wisconsin, Forente stater, 54701
        • HSHS Sacred Heart Hospital
      • Franklin, Wisconsin, Forente stater, 53132
        • Ascension Saint Francis - Reiman Cancer Center
      • Franklin, Wisconsin, Forente stater, 53132
        • Ascension Southeast Wisconsin Hospital - Franklin
      • Green Bay, Wisconsin, Forente stater, 54301
        • Saint Vincent Hospital Cancer Center Green Bay
      • Green Bay, Wisconsin, Forente stater, 54303
        • Saint Vincent Hospital Cancer Center at Saint Mary's
      • Marshfield, Wisconsin, Forente stater, 54449
        • Marshfield Medical Center-Marshfield
      • Medford, Wisconsin, Forente stater, 54451
        • Aspirus Medford Hospital
      • Mequon, Wisconsin, Forente stater, 53097
        • Ascension Columbia Saint Mary's Hospital Ozaukee
      • Milwaukee, Wisconsin, Forente stater, 53210
        • Ascension Southeast Wisconsin Hospital - Saint Joseph Campus
      • Milwaukee, Wisconsin, Forente stater, 53211
        • Ascension Columbia Saint Mary's Hospital - Milwaukee
      • Milwaukee, Wisconsin, Forente stater, 53215
        • Ascension Saint Francis Hospital
      • Minocqua, Wisconsin, Forente stater, 54548
        • Marshfield Medical Center - Minocqua
      • New Richmond, Wisconsin, Forente stater, 54017
        • Cancer Center of Western Wisconsin
      • Oshkosh, Wisconsin, Forente stater, 54904
        • Ascension Mercy Hospital
      • Racine, Wisconsin, Forente stater, 53405
        • Ascension All Saints Hospital
      • Rhinelander, Wisconsin, Forente stater, 54501
        • Aspirus Cancer Care - James Beck Cancer Center
      • Rice Lake, Wisconsin, Forente stater, 54868
        • Marshfield Medical Center-Rice Lake
      • Stevens Point, Wisconsin, Forente stater, 54482
        • Marshfield Medical Center-River Region at Stevens Point
      • Stevens Point, Wisconsin, Forente stater, 54481
        • Aspirus Cancer Care - Stevens Point
      • Sturgeon Bay, Wisconsin, Forente stater, 54235-1495
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
      • Wausau, Wisconsin, Forente stater, 54401
        • Aspirus Regional Cancer Center
      • Wauwatosa, Wisconsin, Forente stater, 53226
        • Ascension Medical Group Southeast Wisconsin - Mayfair Road
      • Weston, Wisconsin, Forente stater, 54476
        • Marshfield Medical Center - Weston
      • Wisconsin Rapids, Wisconsin, Forente stater, 54494
        • Aspirus Cancer Care - Wisconsin Rapids

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

Beskrivelse

Inklusjonskriterier:

  • Har en diagnose av stadium I-III brystkreft
  • Rapporter det verste nivået av tretthet den siste uken som moderat til alvorlig (dvs. en skåre >= 4 på en 0-10 skala, screeningtiltak, spørsmål 1)
  • Ha fullført kirurgi, stråling og/eller kjemoterapi, minst 2 eller flere måneder før påmelding (deltakere kan motta vedlikeholds-, målrettet eller hormonbehandling)
  • Kunne lese og snakke engelsk
  • Foreløpig ikke gravid eller ammer. Kvinner i fertil alder må godta å bruke adekvat prevensjon, dvs. abstinens, spiral (intrauterin enhet), hormonell prevensjon (p-piller) eller barrieremetode (kondomer) før studiestart og under studiedeltakelsens varighet
  • Være i stand til å gi skriftlig informert samtykke

Ekskluderingskriterier:

  • Ta for øyeblikket medisiner som inneholder bupropion (f.eks. Wellbutrin, Forfivo, Aplenzin eller Zyban
  • Ta en monoaminoksidasehemmer (MAOI), linezolid eller metylenblått innen 2 uker før påmelding
  • Ta antipsykotiske medisiner innen en uke før påmelding
  • Har en historie med nedsatt nyrefunksjon (dvs. glomerulær filtrasjonshastighet < 45)
  • Har en historie med skrumplever (dvs. Child-Pugh-score >= 5)
  • Har en historie med anfall
  • Har en historie med bulimi eller anorexia nervosa
  • Rapporter en historie med følsomhet for bupropion
  • Rapporter en allergi mot laktose
  • Har en psykiatrisk eller nevrologisk lidelse som vil forstyrre studiedeltakelsen per lege eller lege

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: ARM I (Bupropion hydrochloride kontrollert-release)
Pasientene får bupropion hydroklorid kontrollert frigjøring PO QD i opptil 13 uker i fravær av sykdomsprogresjon eller uakseptabel toksisitet. Pasienter gjennomgår også blodprøveinnsamling gjennom studien.
Hjelpestudier
Andre navn:
  • Livskvalitetsvurdering
Hjelpestudier
Gjennomgå blodprøvetaking
Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Gitt PO
Andre navn:
  • Zyban
  • Wellbutrin XL
  • Forfivo XL
  • Bupropion HCl kontrollert frigjøring
  • Bupropion HCl Extended Release
  • Bupropion Hydrochloride Extended-Release
  • Wellbutrin SR
Placebo komparator: Arm II (placebo)
Pasientene får placebo PO QD i opptil 13 uker i fravær av sykdomsprogresjon eller uakseptabel toksisitet. Pasienter gjennomgår også blodprøveinnsamling gjennom studien.
Hjelpestudier
Andre navn:
  • Livskvalitetsvurdering
Hjelpestudier
Gjennomgå blodprøvetaking
Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Gitt PO

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Utmattelse
Tidsramme: Ved baseline og 12 uker
Målt ved funksjonsvurderingen av kronisk sykdomsterapi-fatigue (FACIT-F) utmattelsesunderskala (FFS). Skala-score varierer fra 0-4; Lavere score indikerer større tretthet. Vil bruke analyse av samvariasjon med gruppe som hovedfaktor og baseline FFS som et kovariat.
Ved baseline og 12 uker

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Livskvalitet
Tidsramme: Ved baseline og 12 uker
Målt med den totale poengsummen for den funksjonelle vurdering av kreftterapi-Generell (FACT-G) skala (inkludert i FACIT-F). Fact-G består av fire underskalaer: fysisk velvære, funksjonell velvære), emosjonell velvære og sosial velvære. Poeng på de fire underskalaene summeres for å gi en total score fra 0 til 108 med høyere score som indikerer bedre livskvalitet. Dette vil bli brukt til å estimere indirekte (mekling) og direkte effekter og for å oppnå bootstrap-baserte 95% konstruksjonsintervaller for disse effektene.
Ved baseline og 12 uker
Depresjon
Tidsramme: Ved baseline og 12 uker
Målt av pasienten rapporterte resultatmålingsinformasjonssystem (PROMIS) depresjon kort form 8a. Vil utføre meklingsanalyser.
Ved baseline og 12 uker

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Kognisjon
Tidsramme: Ved baseline og 12 uker
Målt ved målene PROMIS kognitiv funksjon 8a og kognitive evner 4a. Skal utføre formidlingsanalyser.
Ved baseline og 12 uker
Symptomatologi
Tidsramme: Ved baseline og 12 uker
Målt ved M.D. Anderson Symptom Inventory.
Ved baseline og 12 uker

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Heather S Jim, University of Rochester NCORP Research Base

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 (Faktiske)

27. juni 2019

Primær fullføring (Antatt)

30. mai 2026

Studiet fullført (Antatt)

5. august 2026

Datoer for studieregistrering

Først innsendt

21. juni 2019

Først innsendt som oppfylte QC-kriteriene

21. juni 2019

Først lagt ut (Faktiske)

24. juni 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. januar 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. januar 2026

Sist bekreftet

1. januar 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • URCC-18007 (Annen identifikator: CTEP)
  • R01CA214647 (U.S. NIH-stipend/kontrakt)
  • UG1CA189961 (U.S. NIH-stipend/kontrakt)
  • NCI-2019-01528 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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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