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Bupropion i reduktion af kræftrelateret træthed i fase I-III brystkræftoverlevere

14. januar 2026 opdateret af: Luke Peppone, University of Rochester NCORP Research Base

Randomiseret placebokontrolleret forsøg med bupropion mod kræftrelateret træthed

Dette fase III-forsøg undersøger, hvor godt bupropion virker til at reducere kræftrelateret træthed hos overlevende af brystkræft i fase I-III. Bupropion er et lægemiddel, der bruges til at behandle depression, samt til at hjælpe folk med at holde op med at ryge. Kræft og dens behandling kan forårsage træthed. At give bupropion kan forbedre kræftrelateret træthed hos brystkræftoverlevere.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

PRIMÆRE MÅL:

I. At bestemme effektiviteten af ​​bupropionhydrochlorid med kontrolleret frigivelse (bupropion) versus placebo til at reducere træthed i et dobbeltblindet, placebokontrolleret, randomiseret klinisk forsøg med brystkræftoverlevere med træthed.

SEKUNDÆRE MÅL:

I. At vurdere effektiviteten af ​​bupropion versus placebo på depression og livskvalitet hos brystkræftoverlevere med træthed.

II. At vurdere tolerabiliteten af ​​bupropion hos brystkræftoverlevere med træthed.

UNDERSØGENDE MÅL:

I. At vurdere effektiviteten af ​​bupropion versus placebo på symptomatologi og kognition hos brystkræftoverlevere med træthed.

II. At udforske virkningerne af bupropion på formodede mekanismer for kræftrelateret træthed.

III. At udforske associationer af CYP2B6-genotype med bupropionmetabolisme og ændringer i træthed.

OVERSIGT: Patienterne randomiseres til 1 ud af 2 arme.

ARM I: Patienter får bupropionhydrochlorid med kontrolleret frigivelse oralt (PO) én gang dagligt (QD) i op til 13 uger i fravær af uacceptabel toksicitet.

ARM II: Patienter får placebo PO QD i op til 13 uger i fravær af uacceptabel toksicitet.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

422

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

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        • University of Michigan Health - West
      • Ypsilanti, Michigan, Forenede Stater, 48197
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
      • Ypsilanti, Michigan, Forenede Stater, 48106
        • Huron Gastroenterology PC
    • Minnesota
      • Burnsville, Minnesota, Forenede Stater, 55337
        • Fairview Ridges Hospital
      • Burnsville, Minnesota, Forenede Stater, 55337
        • Minnesota Oncology - Burnsville
      • Cambridge, Minnesota, Forenede Stater, 55008
        • Cambridge Medical Center
      • Coon Rapids, Minnesota, Forenede Stater, 55433
        • Mercy Hospital
      • Edina, Minnesota, Forenede Stater, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, Forenede Stater, 55432
        • Unity Hospital
      • Maple Grove, Minnesota, Forenede Stater, 55369
        • Fairview Clinics and Surgery Center Maple Grove
      • Maplewood, Minnesota, Forenede Stater, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, Forenede Stater, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, Forenede Stater, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, Forenede Stater, 55407
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, Forenede Stater, 55454
        • Health Partners Inc
      • Monticello, Minnesota, Forenede Stater, 55362
        • Monticello Cancer Center
      • New Ulm, Minnesota, Forenede Stater, 56073
        • New Ulm Medical Center
      • Princeton, Minnesota, Forenede Stater, 55371
        • Fairview Northland Medical Center
      • Robbinsdale, Minnesota, Forenede Stater, 55422
        • North Memorial Medical Health Center
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, Forenede Stater, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, Forenede Stater, 55102
        • United Hospital
      • Shakopee, Minnesota, Forenede Stater, 55379
        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, Forenede Stater, 55082
        • Lakeview Hospital
      • Waconia, Minnesota, Forenede Stater, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, Forenede Stater, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, Forenede Stater, 55125
        • Minnesota Oncology Hematology PA-Woodbury
      • Wyoming, Minnesota, Forenede Stater, 55092
        • Fairview Lakes Medical Center
    • Mississippi
      • Gulfport, Mississippi, Forenede Stater, 39502
        • Gulfport Memorial Hospital
    • Missouri
      • Ballwin, Missouri, Forenede Stater, 63011
        • Saint Louis Cancer and Breast Institute-Ballwin
      • Bolivar, Missouri, Forenede Stater, 65613
        • Central Care Cancer Center - Bolivar
      • Bonne Terre, Missouri, Forenede Stater, 63628
        • Parkland Health Center-Bonne Terre
      • Branson, Missouri, Forenede Stater, 65616
        • Cox Cancer Center Branson
      • Cape Girardeau, Missouri, Forenede Stater, 63703
        • Saint Francis Medical Center
      • Cape Girardeau, Missouri, Forenede Stater, 63703
        • Mercy Cancer Center - Cape Girardeau
      • Farmington, Missouri, Forenede Stater, 63640
        • Parkland Health Center - Farmington
      • Independence, Missouri, Forenede Stater, 64057
        • Centerpoint Medical Center LLC
      • Jefferson City, Missouri, Forenede Stater, 65109
        • MU Health Care Goldschmidt Cancer Center
      • Joplin, Missouri, Forenede Stater, 64804
        • Freeman Health System
      • Joplin, Missouri, Forenede Stater, 64804
        • Mercy Hospital Joplin
      • Kansas City, Missouri, Forenede Stater, 64132
        • Research Medical Center
      • Osage Beach, Missouri, Forenede Stater, 65065
        • Lake Regional Hospital
      • Rolla, Missouri, Forenede Stater, 65401
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Rolla, Missouri, Forenede Stater, 65401
        • Phelps Health Delbert Day Cancer Institute
      • Saint Joseph, Missouri, Forenede Stater, 64506
        • Heartland Regional Medical Center
      • Sainte Genevieve, Missouri, Forenede Stater, 63670
        • Sainte Genevieve County Memorial Hospital
      • Springfield, Missouri, Forenede Stater, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, Forenede Stater, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, Forenede Stater, 63131
        • Missouri Baptist Medical Center
      • St Louis, Missouri, Forenede Stater, 63141
        • Mercy Hospital Saint Louis
      • St Louis, Missouri, Forenede Stater, 63128
        • Mercy Hospital South
      • St Louis, Missouri, Forenede Stater, 63109
        • Saint Louis Cancer and Breast Institute-South City
      • Sullivan, Missouri, Forenede Stater, 63080
        • Missouri Baptist Sullivan Hospital
      • Sunset Hills, Missouri, Forenede Stater, 63127
        • BJC Outpatient Center at Sunset Hills
      • Washington, Missouri, Forenede Stater, 63090
        • Mercy Hospital Washington
    • Montana
      • Missoula, Montana, Forenede Stater, 59802
        • Saint Patrick Hospital - Community Hospital
    • Nevada
      • Carson City, Nevada, Forenede Stater, 89703
        • Carson Tahoe Regional Medical Center
      • Henderson, Nevada, Forenede Stater, 89052
        • Comprehensive Cancer Centers of Nevada - Henderson
      • Henderson, Nevada, Forenede Stater, 89052
        • OptumCare Cancer Care at Seven Hills
      • Henderson, Nevada, Forenede Stater, 89052
        • Cancer and Blood Specialists-Henderson
      • Henderson, Nevada, Forenede Stater, 89052
        • Las Vegas Cancer Center-Henderson
      • Henderson, Nevada, Forenede Stater, 89074
        • Comprehensive Cancer Centers of Nevada-Southeast Henderson
      • Henderson, Nevada, Forenede Stater, 89074
        • GenesisCare USA - Henderson
      • Henderson, Nevada, Forenede Stater, 89052
        • Comprehensive Cancer Centers of Nevada-Horizon Ridge
      • Henderson, Nevada, Forenede Stater, 89074
        • Las Vegas Urology - Green Valley
      • Henderson, Nevada, Forenede Stater, 89074
        • Las Vegas Urology - Pebble
      • Henderson, Nevada, Forenede Stater, 89074
        • Urology Specialists of Nevada - Green Valley
      • Las Vegas, Nevada, Forenede Stater, 89144
        • Summerlin Hospital Medical Center
      • Las Vegas, Nevada, Forenede Stater, 89109
        • Sunrise Hospital and Medical Center
      • Las Vegas, Nevada, Forenede Stater, 89102
        • OptumCare Cancer Care at Charleston
      • Las Vegas, Nevada, Forenede Stater, 89106
        • Radiation Oncology Centers of Nevada Central
      • Las Vegas, Nevada, Forenede Stater, 89109
        • GenesisCare USA - Las Vegas
      • Las Vegas, Nevada, Forenede Stater, 89119
        • Radiation Oncology Centers of Nevada Southeast
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Comprehensive Cancer Centers of Nevada - Northwest
      • Las Vegas, Nevada, Forenede Stater, 89128
        • OptumCare Cancer Care at MountainView
      • Las Vegas, Nevada, Forenede Stater, 89135
        • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
      • Las Vegas, Nevada, Forenede Stater, 89144
        • Comprehensive Cancer Centers of Nevada - Town Center
      • Las Vegas, Nevada, Forenede Stater, 89144
        • Comprehensive Cancer Centers of Nevada-Summerlin
      • Las Vegas, Nevada, Forenede Stater, 89148
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, Forenede Stater, 89148
        • OptumCare Cancer Care at Fort Apache
      • Las Vegas, Nevada, Forenede Stater, 89169
        • Comprehensive Cancer Centers of Nevada - Central Valley
      • Las Vegas, Nevada, Forenede Stater, 89102
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, Forenede Stater, 89106
        • Cancer and Blood Specialists-Shadow
      • Las Vegas, Nevada, Forenede Stater, 89109
        • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
      • Las Vegas, Nevada, Forenede Stater, 89113
        • HealthCare Partners Medical Group Oncology/Hematology-San Martin
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Cancer and Blood Specialists-Tenaya
      • Las Vegas, Nevada, Forenede Stater, 89128
        • GenesisCare USA - Vegas Tenaya
      • Las Vegas, Nevada, Forenede Stater, 89128
        • HealthCare Partners Medical Group Oncology/Hematology-Tenaya
      • Las Vegas, Nevada, Forenede Stater, 89148-2405
        • Las Vegas Cancer Center-Medical Center
      • Las Vegas, Nevada, Forenede Stater, 89148
        • GenesisCare USA - Fort Apache
      • Las Vegas, Nevada, Forenede Stater, 89149
        • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Ann M Wierman MD LTD
      • Las Vegas, Nevada, Forenede Stater, 89074
        • Las Vegas Urology - Pecos
      • Las Vegas, Nevada, Forenede Stater, 89102
        • Desert West Surgery
      • Las Vegas, Nevada, Forenede Stater, 89103
        • Hope Cancer Care of Nevada
      • Las Vegas, Nevada, Forenede Stater, 89106
        • Urology Specialists of Nevada - Central
      • Las Vegas, Nevada, Forenede Stater, 89113
        • Las Vegas Prostate Cancer Center
      • Las Vegas, Nevada, Forenede Stater, 89113
        • Las Vegas Urology - Sunset
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Las Vegas Urology - Cathedral Rock
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Las Vegas Urology - Smoke Ranch
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Urology Specialists of Nevada - Northwest
      • Las Vegas, Nevada, Forenede Stater, 89169
        • University Cancer Center
      • Las Vegas, Nevada, Forenede Stater, 89113
        • Urology Specialists of Nevada - Southwest
      • Pahrump, Nevada, Forenede Stater, 89048
        • Hope Cancer Care of Nevada-Pahrump
      • Reno, Nevada, Forenede Stater, 89502
        • Renown Regional Medical Center
      • Reno, Nevada, Forenede Stater, 89503
        • Saint Mary's Regional Medical Center
      • Reno, Nevada, Forenede Stater, 89509
        • Radiation Oncology Associates
    • New York
      • Greenlawn, New York, Forenede Stater, 11740
        • Northwell Health Cancer Institute at Huntington
      • Lake Success, New York, Forenede Stater, 11042
        • Northwell Health/Center for Advanced Medicine
    • North Carolina
      • Asheboro, North Carolina, Forenede Stater, 27203
        • Randolph Hospital
      • Asheboro, North Carolina, Forenede Stater, 27203
        • Cone Health Cancer Center at Asheboro
      • Asheboro, North Carolina, Forenede Stater, 27205
        • Cone Health MedCenter Asheboro
      • Burlington, North Carolina, Forenede Stater, 27215
        • Cone Health Cancer Center at Alamance Regional
      • Gastonia, North Carolina, Forenede Stater, 28054
        • CaroMont Regional Medical Center
      • Greensboro, North Carolina, Forenede Stater, 27403
        • Cone Health Cancer Center
      • Greensboro, North Carolina, Forenede Stater, 27410
        • Cone Health Cancer Center at Drawbridge Parkway
      • Greensboro, North Carolina, Forenede Stater, 27403
        • Novant Health Breast Surgery - Greensboro
      • Hendersonville, North Carolina, Forenede Stater, 28791
        • Margaret R Pardee Memorial Hospital
      • Kernersville, North Carolina, Forenede Stater, 27284
        • Novant Health Cancer Institute - Kernersville
      • Mount Airy, North Carolina, Forenede Stater, 27030
        • Novant Health Cancer Institute - Mount Airy
      • Nags Head, North Carolina, Forenede Stater, 27959
        • Outer Banks Hospital
      • North Wilkesboro, North Carolina, Forenede Stater, 28659
        • Novant Health Cancer Institute - Wilkesboro
      • Reidsville, North Carolina, Forenede Stater, 27320
        • Annie Penn Memorial Hospital
      • Stateville, North Carolina, Forenede Stater, 28625
        • Novant Health Cancer Institute - Statesville
      • Thomasville, North Carolina, Forenede Stater, 27360
        • Novant Health Cancer Institute - Thomasville
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Novant Health Forsyth Medical Center
    • Ohio
      • Beavercreek, Ohio, Forenede Stater, 45431
        • Indu and Raj Soin Medical Center
      • Belpre, Ohio, Forenede Stater, 45714
        • Strecker Cancer Center-Belpre
      • Boardman, Ohio, Forenede Stater, 44512
        • Saint Elizabeth Boardman Hospital
      • Centerville, Ohio, Forenede Stater, 45459
        • Miami Valley Hospital South
      • Centerville, Ohio, Forenede Stater, 45459
        • Dayton Physicians LLC-Miami Valley South
      • Chillicothe, Ohio, Forenede Stater, 45601
        • Adena Regional Medical Center
      • Cincinnati, Ohio, Forenede Stater, 45236
        • Oncology Hematology Care Inc-Kenwood
      • Columbus, Ohio, Forenede Stater, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, Forenede Stater, 43219
        • The Mark H Zangmeister Center
      • Columbus, Ohio, Forenede Stater, 43214
        • Columbus Oncology and Hematology Associates Inc
      • Columbus, Ohio, Forenede Stater, 43228
        • Doctors Hospital
      • Columbus, Ohio, Forenede Stater, 43213
        • Mount Carmel East Hospital
      • Columbus, Ohio, Forenede Stater, 43215
        • Grant Medical Center
      • Columbus, Ohio, Forenede Stater, 43222
        • Mount Carmel Health Center West
      • Dayton, Ohio, Forenede Stater, 45406
        • Good Samaritan Hospital - Dayton
      • Dayton, Ohio, Forenede Stater, 45409
        • Miami Valley Hospital
      • Dayton, Ohio, Forenede Stater, 45415
        • Miami Valley Hospital North
      • Dayton, Ohio, Forenede Stater, 45415
        • Dayton Physician LLC - Englewood
      • Delaware, Ohio, Forenede Stater, 43015
        • Delaware Health Center-Grady Cancer Center
      • Delaware, Ohio, Forenede Stater, 43015
        • Grady Memorial Hospital
      • Dublin, Ohio, Forenede Stater, 43016
        • Dublin Methodist Hospital
      • Dublin, Ohio, Forenede Stater, 43016
        • Columbus Oncology and Hematology Associates
      • Findlay, Ohio, Forenede Stater, 45840
        • Blanchard Valley Hospital
      • Findlay, Ohio, Forenede Stater, 45840
        • Armes Family Cancer Center
      • Findlay, Ohio, Forenede Stater, 45840
        • Orion Cancer Care
      • Franklin, Ohio, Forenede Stater, 45005-1066
        • Atrium Medical Center-Middletown Regional Hospital
      • Franklin, Ohio, Forenede Stater, 45005
        • Dayton Physicians LLC-Atrium
      • Gahanna, Ohio, Forenede Stater, 43230
        • Central Ohio Breast and Endocrine Surgery
      • Greenville, Ohio, Forenede Stater, 45331
        • Wayne Hospital
      • Greenville, Ohio, Forenede Stater, 45331
        • Dayton Physicians LLC-Wayne
      • Grove City, Ohio, Forenede Stater, 43123
        • Mount Carmel Grove City Hospital
      • Grove City, Ohio, Forenede Stater, 43123
        • Zangmeister Center Grove City
      • Kettering, Ohio, Forenede Stater, 45429
        • Kettering Medical Center
      • Kettering, Ohio, Forenede Stater, 45409
        • Greater Dayton Cancer Center
      • Kettering, Ohio, Forenede Stater, 45420
        • First Dayton Cancer Care
      • Lancaster, Ohio, Forenede Stater, 43130
        • Fairfield Medical Center
      • Lima, Ohio, Forenede Stater, 45801
        • Saint Rita's Medical Center
      • Mansfield, Ohio, Forenede Stater, 44903
        • OhioHealth Mansfield Hospital
      • Marietta, Ohio, Forenede Stater, 45750
        • Marietta Memorial Hospital
      • Marion, Ohio, Forenede Stater, 43302
        • OhioHealth Marion General Hospital
      • Marysville, Ohio, Forenede Stater, 43040
        • Memorial Hospital
      • Mount Vernon, Ohio, Forenede Stater, 43050
        • Knox Community Hospital
      • New Albany, Ohio, Forenede Stater, 43054
        • Mount Carmel New Albany Surgical Hospital
      • Newark, Ohio, Forenede Stater, 43055
        • Licking Memorial Hospital
      • Newark, Ohio, Forenede Stater, 43055
        • Newark Radiation Oncology
      • Perrysburg, Ohio, Forenede Stater, 43551
        • Mercy Health - Perrysburg Hospital
      • Portsmouth, Ohio, Forenede Stater, 45662
        • Southern Ohio Medical Center
      • Springfield, Ohio, Forenede Stater, 45504
        • Springfield Regional Cancer Center
      • Springfield, Ohio, Forenede Stater, 45504
        • Springfield Regional Medical Center
      • Toledo, Ohio, Forenede Stater, 43623
        • Mercy Health - Saint Anne Hospital
      • Toledo, Ohio, Forenede Stater, 43608
        • Mercy Health - Saint Vincent Hospital
      • Toledo, Ohio, Forenede Stater, 43623
        • Mercy Health Sylvania Radiation Oncology Center
      • Troy, Ohio, Forenede Stater, 45373
        • Upper Valley Medical Center
      • Troy, Ohio, Forenede Stater, 45373
        • Dayton Physicians LLC - Troy
      • Warren, Ohio, Forenede Stater, 44484
        • Saint Joseph Warren Hospital
      • Westerville, Ohio, Forenede Stater, 43081
        • Saint Ann's Hospital
      • Wilmington, Ohio, Forenede Stater, 45177
        • Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center
      • Wpafb, Ohio, Forenede Stater, 45433
        • Wright-Patterson Medical Center
      • Youngstown, Ohio, Forenede Stater, 44501
        • Saint Elizabeth Youngstown Hospital
      • Zanesville, Ohio, Forenede Stater, 43701
        • Genesis Healthcare System Cancer Care Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73120
        • Mercy Hospital Oklahoma City
    • Oregon
      • Bend, Oregon, Forenede Stater, 97701
        • Saint Charles Health System
      • Clackamas, Oregon, Forenede Stater, 97015
        • Clackamas Radiation Oncology Center
      • Clackamas, Oregon, Forenede Stater, 97015
        • Providence Cancer Institute Clackamas Clinic
      • Coos Bay, Oregon, Forenede Stater, 97420
        • Bay Area Hospital
      • Newberg, Oregon, Forenede Stater, 97132
        • Providence Newberg Medical Center
      • Oregon City, Oregon, Forenede Stater, 97045
        • Providence Willamette Falls Medical Center
      • Portland, Oregon, Forenede Stater, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, Forenede Stater, 97225
        • Providence Saint Vincent Medical Center
      • Redmond, Oregon, Forenede Stater, 97756
        • Saint Charles Health System-Redmond
    • Pennsylvania
      • Allentown, Pennsylvania, Forenede Stater, 18103
        • Lehigh Valley Hospital-Cedar Crest
      • Bethlehem, Pennsylvania, Forenede Stater, 18017
        • Lehigh Valley Hospital - Muhlenberg
      • Chadds Ford, Pennsylvania, Forenede Stater, 19317
        • Christiana Care Health System-Concord Health Center
      • Danville, Pennsylvania, Forenede Stater, 17822
        • Geisinger Medical Center
      • East Stroudsburg, Pennsylvania, Forenede Stater, 18301
        • Pocono Medical Center
      • Hazleton, Pennsylvania, Forenede Stater, 18201
        • Geisinger Medical Center-Cancer Center Hazleton
      • Hazleton, Pennsylvania, Forenede Stater, 18201
        • Lehigh Valley Hospital-Hazleton
      • Lewisburg, Pennsylvania, Forenede Stater, 17837
        • Geisinger Medical Oncology-Lewisburg
      • Lewistown, Pennsylvania, Forenede Stater, 17044
        • Lewistown Hospital
      • Pottsville, Pennsylvania, Forenede Stater, 17901
        • Geisinger Cancer Services-Pottsville
      • Scranton, Pennsylvania, Forenede Stater, 18510
        • Community Medical Center
      • Selinsgrove, Pennsylvania, Forenede Stater, 17870
        • Geisinger Medical Oncology-Selinsgrove
      • State College, Pennsylvania, Forenede Stater, 16801
        • Geisinger Medical Group
      • Wilkes-Barre, Pennsylvania, Forenede Stater, 18711
        • Geisinger Wyoming Valley/Henry Cancer Center
    • South Carolina
      • Bluffton, South Carolina, Forenede Stater, 29910
        • Saint Joseph's/Candler - Bluffton Campus
      • Boiling Springs, South Carolina, Forenede Stater, 29316
        • Prisma Health Cancer Institute - Spartanburg
      • Easley, South Carolina, Forenede Stater, 29640
        • Prisma Health Cancer Institute - Easley
      • Gaffney, South Carolina, Forenede Stater, 29341
        • Gibbs Cancer Center-Gaffney
      • Greenville, South Carolina, Forenede Stater, 29605
        • Prisma Health Cancer Institute - Faris
      • Greenville, South Carolina, Forenede Stater, 29607
        • Saint Francis Cancer Center
      • Greenville, South Carolina, Forenede Stater, 29615
        • Prisma Health Cancer Institute - Eastside
      • Greenville, South Carolina, Forenede Stater, 29605
        • Prisma Health Cancer Institute - Butternut
      • Greenville, South Carolina, Forenede Stater, 29601
        • Saint Francis Hospital
      • Greenville, South Carolina, Forenede Stater, 29605
        • Prisma Health Greenville Memorial Hospital
      • Greer, South Carolina, Forenede Stater, 29650
        • Prisma Health Cancer Institute - Greer
      • Greer, South Carolina, Forenede Stater, 29651
        • Gibbs Cancer Center-Pelham
      • Hilton Head Island, South Carolina, Forenede Stater, 29926-3827
        • South Carolina Cancer Specialists PC
      • Seneca, South Carolina, Forenede Stater, 29672
        • Prisma Health Cancer Institute - Seneca
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • Spartanburg Medical Center
      • Spartanburg, South Carolina, Forenede Stater, 29307
        • Spartanburg Medical Center - Mary Black Campus
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • North Grove Medical Park
      • Union, South Carolina, Forenede Stater, 29379
        • SMC Center for Hematology Oncology Union
    • Tennessee
      • Cookeville, Tennessee, Forenede Stater, 38501
        • Cookeville Regional Medical Center
    • Virginia
      • Chesapeake, Virginia, Forenede Stater, 23320
        • Chesapeake Regional Medical Center
      • Martinsville, Virginia, Forenede Stater, 24112
        • Sovah Health Martinsville
      • Mechanicsville, Virginia, Forenede Stater, 23116
        • Bon Secours Memorial Regional Medical Center
      • Midlothian, Virginia, Forenede Stater, 23114
        • Bon Secours Saint Francis Medical Center
      • Midlothian, Virginia, Forenede Stater, 23113
        • Bon Secours Westchester Emergency Center
      • Norfolk, Virginia, Forenede Stater, 23505
        • Bon Secours DePaul Medical Center
      • Portsmouth, Virginia, Forenede Stater, 23707
        • Bon Secours Maryview Medical Center
      • Richmond, Virginia, Forenede Stater, 23226
        • Bon Secours Saint Mary's Hospital
      • Richmond, Virginia, Forenede Stater, 23230
        • Bon Secours Cancer Institute at Reynolds Crossing
      • Richmond, Virginia, Forenede Stater, 23223
        • Bon Secours Richmond Community Hospital
      • Suffolk, Virginia, Forenede Stater, 23435
        • Bon Secours Health Center at Harbour View
    • Washington
      • Aberdeen, Washington, Forenede Stater, 98520
        • Providence Regional Cancer System-Aberdeen
      • Bellevue, Washington, Forenede Stater, 98004
        • Overlake Medical Center
      • Bellingham, Washington, Forenede Stater, 98225
        • PeaceHealth Saint Joseph Medical Center
      • Centralia, Washington, Forenede Stater, 98531
        • Providence Regional Cancer System-Centralia
      • Edmonds, Washington, Forenede Stater, 98026
        • Swedish Cancer Institute-Edmonds
      • Everett, Washington, Forenede Stater, 98201
        • Providence Regional Cancer Partnership
      • Issaquah, Washington, Forenede Stater, 98029
        • Swedish Cancer Institute-Issaquah
      • Kennewick, Washington, Forenede Stater, 99336
        • Kadlec Clinic Hematology and Oncology
      • Lacey, Washington, Forenede Stater, 98503
        • Providence Regional Cancer System-Lacey
      • Longview, Washington, Forenede Stater, 98632
        • PeaceHealth Saint John Medical Center
      • Mount Vernon, Washington, Forenede Stater, 98274
        • Skagit Regional Health Cancer Care Center
      • Port Townsend, Washington, Forenede Stater, 98368
        • Jefferson Healthcare
      • Renton, Washington, Forenede Stater, 98055
        • Valley Medical Center
      • Seattle, Washington, Forenede Stater, 98107
        • Swedish Medical Center-Ballard Campus
      • Seattle, Washington, Forenede Stater, 98122
        • Swedish Medical Center-First Hill
      • Seattle, Washington, Forenede Stater, 98104
        • Pacific Gynecology Specialists
      • Seattle, Washington, Forenede Stater, 98122-5711
        • Swedish Medical Center-Cherry Hill
      • Sedro-Woolley, Washington, Forenede Stater, 98284
        • PeaceHealth United General Medical Center
      • Shelton, Washington, Forenede Stater, 98584
        • Providence Regional Cancer System-Shelton
      • Vancouver, Washington, Forenede Stater, 98664
        • PeaceHealth Southwest Medical Center
      • Walla Walla, Washington, Forenede Stater, 99362
        • Providence Saint Mary Regional Cancer Center
      • Yakima, Washington, Forenede Stater, 98902
        • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
      • Yelm, Washington, Forenede Stater, 98597
        • Providence Regional Cancer System-Yelm
    • Wisconsin
      • Antigo, Wisconsin, Forenede Stater, 54409
        • Langlade Hospital and Cancer Center
      • Appleton, Wisconsin, Forenede Stater, 54911
        • ThedaCare Regional Cancer Center
      • Appleton, Wisconsin, Forenede Stater, 54915
        • Ascension Saint Elizabeth Hospital
      • Brookfield, Wisconsin, Forenede Stater, 53045
        • Ascension Southeast Wisconsin Hospital - Elmbrook Campus
      • Chilton, Wisconsin, Forenede Stater, 53014
        • Ascension Calumet Hospital
      • Eau Claire, Wisconsin, Forenede Stater, 54701
        • Marshfield Medical Center-EC Cancer Center
      • Eau Claire, Wisconsin, Forenede Stater, 54701
        • HSHS Sacred Heart Hospital
      • Franklin, Wisconsin, Forenede Stater, 53132
        • Ascension Saint Francis - Reiman Cancer Center
      • Franklin, Wisconsin, Forenede Stater, 53132
        • Ascension Southeast Wisconsin Hospital - Franklin
      • Green Bay, Wisconsin, Forenede Stater, 54301
        • Saint Vincent Hospital Cancer Center Green Bay
      • Green Bay, Wisconsin, Forenede Stater, 54303
        • Saint Vincent Hospital Cancer Center at Saint Mary's
      • Marshfield, Wisconsin, Forenede Stater, 54449
        • Marshfield Medical Center-Marshfield
      • Medford, Wisconsin, Forenede Stater, 54451
        • Aspirus Medford Hospital
      • Mequon, Wisconsin, Forenede Stater, 53097
        • Ascension Columbia Saint Mary's Hospital Ozaukee
      • Milwaukee, Wisconsin, Forenede Stater, 53210
        • Ascension Southeast Wisconsin Hospital - Saint Joseph Campus
      • Milwaukee, Wisconsin, Forenede Stater, 53211
        • Ascension Columbia Saint Mary's Hospital - Milwaukee
      • Milwaukee, Wisconsin, Forenede Stater, 53215
        • Ascension Saint Francis Hospital
      • Minocqua, Wisconsin, Forenede Stater, 54548
        • Marshfield Medical Center - Minocqua
      • New Richmond, Wisconsin, Forenede Stater, 54017
        • Cancer Center of Western Wisconsin
      • Oshkosh, Wisconsin, Forenede Stater, 54904
        • Ascension Mercy Hospital
      • Racine, Wisconsin, Forenede Stater, 53405
        • Ascension All Saints Hospital
      • Rhinelander, Wisconsin, Forenede Stater, 54501
        • Aspirus Cancer Care - James Beck Cancer Center
      • Rice Lake, Wisconsin, Forenede Stater, 54868
        • Marshfield Medical Center-Rice Lake
      • Stevens Point, Wisconsin, Forenede Stater, 54482
        • Marshfield Medical Center-River Region at Stevens Point
      • Stevens Point, Wisconsin, Forenede Stater, 54481
        • Aspirus Cancer Care - Stevens Point
      • Sturgeon Bay, Wisconsin, Forenede Stater, 54235-1495
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
      • Wausau, Wisconsin, Forenede Stater, 54401
        • Aspirus Regional Cancer Center
      • Wauwatosa, Wisconsin, Forenede Stater, 53226
        • Ascension Medical Group Southeast Wisconsin - Mayfair Road
      • Weston, Wisconsin, Forenede Stater, 54476
        • Marshfield Medical Center - Weston
      • Wisconsin Rapids, Wisconsin, Forenede Stater, 54494
        • Aspirus Cancer Care - Wisconsin Rapids

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

Beskrivelse

Inklusionskriterier:

  • Har en diagnose af stadium I-III brystkræft
  • Rapportér det værste niveau af træthed i den seneste uge som moderat til svær (dvs. en score >= 4 på en 0-10 skala, screeningsforanstaltninger, spørgsmål 1)
  • Har gennemført operation, stråling og/eller kemoterapi mindst 2 eller flere måneder før tilmelding (deltagere kan modtage vedligeholdelses-, målrettet eller hormonbehandling)
  • Kan læse og tale engelsk
  • I øjeblikket ikke gravid eller ammende. Kvinder i den fødedygtige alder skal acceptere at bruge passende prævention, dvs. abstinens, spiral (intrauterin enhed), hormonelle præventionsmidler (p-piller) eller barrieremetode (kondomer) før studiestart og i løbet af undersøgelsens deltagelse
  • Være i stand til at give skriftligt informeret samtykke

Ekskluderingskriterier:

  • Tag i øjeblikket medicin, der indeholder bupropion (f.eks. Wellbutrin, Forfivo, Aplenzin eller Zyban
  • Tag en monoaminoxidasehæmmer (MAOI), linezolid eller methylenblåt inden for 2 uger før tilmelding
  • Tag antipsykotisk medicin inden for en uge før tilmelding
  • Har en historie med nedsat nyrefunktion (dvs. glomerulær filtrationshastighed < 45)
  • Har en historie med cirrhose (dvs. Child-Pugh-score >= 5)
  • Har en historie med anfald
  • Har en historie med bulimi eller anorexia nervosa
  • Rapporter en historie med følsomhed over for bupropion
  • Rapporter en allergi over for laktose
  • Har en psykiatrisk eller neurologisk lidelse, der ville forstyrre studiedeltagelse pr. læge eller læges udpegede

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm I (bupropion hydrochlorid kontrolleret frigivelse)
Patienter modtager bupropion-hydrochlorid-kontrolleret frigivelse PO QD i op til 13 uger i fravær af sygdomsprogression eller uacceptabel toksicitet. Patienter gennemgår også blodprøveopsamling i hele undersøgelsen.
Andet: Livskvalitetsvurdering
Hjælpestudier
Andre navne:
  • Livskvalitetsvurdering
Andet: Spørgeskemaadministration
Hjælpestudier
Procedure: Bioprøvesamling
Gennemgå blodprøvetagning
Andre navne:
  • Biologisk prøvesamling
  • Bioprøve indsamlet
  • Prøvesamling
Medicin: Bupropion Hydrochlorid kontrolleret frigivelse
Givet PO
Andre navne:
  • Zyban
  • Wellbutrin XL
  • Forfivo XL
  • Bupropion HCl kontrolleret frigivelse
  • Bupropion HCl forlænget frigivelse
  • Bupropion Hydrochloride Extended-Release
  • Wellbutrin SR
Placebo komparator: Arm II (placebo)
Patienter får placebo PO QD i op til 13 uger i mangel af sygdomsprogression eller uacceptabel toksicitet. Patienter gennemgår også blodprøveopsamling i hele undersøgelsen.
Andet: Livskvalitetsvurdering
Hjælpestudier
Andre navne:
  • Livskvalitetsvurdering
Andet: Spørgeskemaadministration
Hjælpestudier
Procedure: Bioprøvesamling
Gennemgå blodprøvetagning
Andre navne:
  • Biologisk prøvesamling
  • Bioprøve indsamlet
  • Prøvesamling
Andet: Placebo administration
Givet PO

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Træthed
Tidsramme: Ved baseline og 12 uger
Målt ved den funktionelle vurdering af kronisk sygdom terapi-fatigue (FACIT-F) træthedsunderskala (FFS). Skala-scoringer varierer fra 0-4; Lavere score indikerer større træthed. Vil bruge analyse af covarians med gruppe som hovedfaktor og baseline FFS som et covariat.
Ved baseline og 12 uger

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Livskvalitet
Tidsramme: Ved baseline og 12 uger
Målt ved den samlede score for den funktionelle vurderingskræftbehandling-generel (FACT-G) skala (inkluderet i FACIT-F). Fakta-G består af fire underskalaer: fysisk velvære, funktionel velvære), følelsesmæssig velvære og socialt velvære. Resultater på de fire underskalaer opsummeres for at producere en total score i området fra 0 til 108 med højere score, der indikerer bedre livskvalitet. Dette vil blive brugt til at estimere de indirekte (mægling) og direkte effekter og til at opnå bootstrap-baserede 95% tillidsintervaller for disse effekter.
Ved baseline og 12 uger
Depression
Tidsramme: Ved baseline og 12 uger
Målt af patienten rapporterede Resultater Målingsinformationssystem (PROMIS) Depression Short Form 8A. Vil udføre mæglingsanalyser.
Ved baseline og 12 uger

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Erkendelse
Tidsramme: Ved baseline og 12 uger
Målt ved PROMIS Cognitive Functioning 8a og Cognitive Abilities 4a målene. Vil udføre mediationsanalyser.
Ved baseline og 12 uger
Symptomatologi
Tidsramme: Ved baseline og 12 uger
Målt ved M.D. Anderson Symptom Inventory.
Ved baseline og 12 uger

Samarbejdspartnere og efterforskere

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

Sponsor

University of Rochester NCORP Research Base

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

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

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)

27. juni 2019

Primær færdiggørelse (Anslået)

30. maj 2026

Studieafslutning (Anslået)

5. august 2026

Datoer for studieregistrering

Først indsendt

21. juni 2019

Først indsendt, der opfyldte QC-kriterier

21. juni 2019

Først opslået (Faktiske)

24. juni 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. januar 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. januar 2026

Sidst verificeret

1. januar 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • URCC-18007 (Anden identifikator: CTEP)
  • R01CA214647 (U.S. NIH-bevilling/kontrakt)
  • UG1CA189961 (U.S. NIH-bevilling/kontrakt)
  • NCI-2019-01528 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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 .

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CROs by country

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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