Sammenligning af kosttilskud til forebyggelse af vægttab hos patienter med kræft
6. december 2016 opdateret af: Radiation Therapy Oncology Group
En dobbeltblind undersøgelse af ernæringsintervention til behandling af kræftkakeksi ved hjælp af Juven® kosttilskud
RATIONALE: Kosttilskud kan hjælpe med at forhindre tab af appetit, vægttab og træthed hos patienter med fremskreden cancer.
FORMÅL: Randomiseret fase III-forsøg for at sammenligne effektiviteten af to kosttilskud til at forhindre tab af appetit, vægttab og træthed hos patienter, som har fase III eller fase IV solide tumorer.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
MÅL:
- Sammenlign ændringen i slank kropsmasse hos patienter behandlet med Juven® vs et ikke-Juven®-tilskud.
- Sammenlign ændringen i træthed og livskvalitet hos patienter behandlet med disse kosttilskud.
- Sammenlign resultaterne af plethysmografi, bioimpedans og hudfoldsmåling hos patienter behandlet med disse kosttilskud.
- Sammenlign vægtændringen hos patienter behandlet med disse kosttilskud.
OVERSIGT: Dette er en randomiseret, dobbeltblind, multicenterundersøgelse. Patienterne er stratificeret efter primært sygdomssted (lunge vs. andre), samtidig kemoterapi (ja vs nej), tegn på metastaser (ja vs nej) og grad af vægttab (2-5% vs 6-10%). Patienterne randomiseres til 1 ud af 2 behandlingsarme.
- Arm I: Patienterne får oralt Juven®-tilskud to gange dagligt i 8 uger.
- Arm II: Patienter får oralt non-Juven®-tilskud to gange dagligt i 8 uger. Alle patienter gennemgår måling af mager kropsmasse (for at inkludere flere kropssammensætning og vægtændringer) og trætheds- og livskvalitetsvurderinger ved baseline og derefter efter 4 og 8 uger.
PROJEKTERET TILSLUTNING: I alt 468 patienter (234 pr. behandlingsarm) vil blive akkumuleret til denne undersøgelse inden for 16 måneder.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
472
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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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Centre - Calgary
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
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New Brunswick
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Moncton, New Brunswick, Canada, E1C 8X3
- Doctor Leon Richard Oncology Centre
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Saint John, New Brunswick, Canada, E2L 4L2
- Saint John Regional Hospital
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Newfoundland and Labrador
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St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
- Newfoundland Cancer Treatment and Research Foundation
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
- Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Margaret and Charles Juravinski Cancer Centre
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Kingston, Ontario, Canada, K7L 5P9
- Cancer Centre of Southeastern Ontario
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London, Ontario, Canada, N6A 4L6
- London Regional Cancer Program at London Health Sciences Centre
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Ottawa, Ontario, Canada, K1H 8L6
- Ottawa Hospital Regional Cancer Centre - General Campus
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Sudbury, Ontario, Canada, P3E 5J1
- Northeastern Ontario Regional Cancer Centre
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Thunder Bay, Ontario, Canada, P7B 6V4
- Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
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Toronto, Ontario, Canada, M4N 3M5
- Toronto Sunnybrook Regional Cancer Centre
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
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Quebec
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Montreal, Quebec, Canada, H2W 1S6
- McGill Cancer Centre at McGill University
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Montreal, Quebec, Canada, H2L 4MI
- Centre Hospitalier de l'Université de Montréal
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Quebec City, Quebec, Canada, G1R 2J6
- Centre Hospitalier Universitaire de Quebec
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Sherbrooke, Quebec, Canada, J1H 5N4
- CHUS-Hopital Fleurimont
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre at Pasqua Hospital
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre
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Alabama
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Birmingham, Alabama, Forenede Stater, 35294-3300
- Comprehensive Cancer Center at University of Alabama at Birmingham
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Huntsville, Alabama, Forenede Stater, 35801
- Comprehensive Cancer Institute
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Mobile, Alabama, Forenede Stater, 36607
- MBCCOP - Gulf Coast
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Montgomery, Alabama, Forenede Stater, 36106-3657
- Montgomery Cancer Center
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Tuscaloosa, Alabama, Forenede Stater, 35401
- DCH Cancer Treatment Center
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Arizona
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Phoenix, Arizona, Forenede Stater, 85013
- Foundation for Cancer Research and Education
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California
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Burbank, California, Forenede Stater, 91505
- Providence Saint Joseph Medical Center - Burbank
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Concord, California, Forenede Stater, 94524-4110
- Mount Diablo Regional Cancer Center
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Duarte, California, Forenede Stater, 91010-3000
- City of Hope Comprehensive Cancer Center
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Fresno, California, Forenede Stater, 93720
- Saint Agnes Cancer Center
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Fresno, California, Forenede Stater, 93720
- California Cancer Center - Woodward Park Office
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Greenbrae, California, Forenede Stater, 94904
- Sutter Health Western Division Cancer Research Group
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Loma Linda, California, Forenede Stater, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Long Beach, California, Forenede Stater, 90822
- Veterans Affairs Medical Center - Long Beach
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Los Angeles, California, Forenede Stater, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Los Angeles, California, Forenede Stater, 90095-1714
- Jonsson Comprehensive Cancer Center at UCLA
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Oakland, California, Forenede Stater, 94609-3305
- CCOP - Bay Area Tumor Institute
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Pasadena, California, Forenede Stater, 91105
- Huntington Cancer Center at Huntington Hospital
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Pomona, California, Forenede Stater, 91767
- Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
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Sacramento, California, Forenede Stater, 95815
- Radiation Oncology Centers - Sacramento
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San Diego, California, Forenede Stater, 92134-3202
- Naval Medical Center - San Diego
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San Diego, California, Forenede Stater, 92101-1492
- Radiation Medical Group, Incorporated
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San Francisco, California, Forenede Stater, 94115
- UCSF Comprehensive Cancer Center
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San Jose, California, Forenede Stater, 95128
- O'Connor Hospital
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Santa Rosa, California, Forenede Stater, 95403
- CCOP - Santa Rosa Memorial Hospital
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Stockton, California, Forenede Stater, 95204
- St. Joseph's Regional Cancer Center
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Torrance, California, Forenede Stater, 90505
- Torrance Memorial Medical Center
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Travis Air Force Base, California, Forenede Stater, 94535
- General Robert Huyser Cancer Center at David Grant Medical Center
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Colorado
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Colorado Springs, Colorado, Forenede Stater, 80909
- Memorial Hospital Cancer Center
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Denver, Colorado, Forenede Stater, 80010
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
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Grand Junction, Colorado, Forenede Stater, 81502-1628
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06511
- Hospital of Saint Raphael
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New Haven, Connecticut, Forenede Stater, 06520-8040
- Yale Comprehensive Cancer Center
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Delaware
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Newark, Delaware, Forenede Stater, 19713
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20016
- Sibley Memorial Hospital
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Florida
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Fort Myers, Florida, Forenede Stater, 33901-8082
- 21st Century Oncology - Fort Myers
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Gainesville, Florida, Forenede Stater, 32610-0385
- University of Florida Shands Cancer Center
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Jacksonville, Florida, Forenede Stater, 32207
- Florida Radiation Oncology Group
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Melbourne, Florida, Forenede Stater, 32901-3276
- Holmes Regional Medical Center
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Miami, Florida, Forenede Stater, 33136
- University of Miami Sylvester Comprehensive Cancer Center
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Miami, Florida, Forenede Stater, 33176-2197
- Baptist-South Miami Regional Cancer Program
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Miami Beach, Florida, Forenede Stater, 33140
- CCOP - Mount Sinai Medical Center
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Panama City, Florida, Forenede Stater, 32405-4587
- Gulf Coast Cancer Treatment Center
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Panama City, Florida, Forenede Stater, 32401
- Bay Medical Center
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Sarasota, Florida, Forenede Stater, 34233
- Sarasota Radiation and Medical Oncology Center
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Tallahassee, Florida, Forenede Stater, 32308
- Tallahassee Memorial Hospital
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Tampa, Florida, Forenede Stater, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322
- Winship Cancer Institute of Emory University
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Atlanta, Georgia, Forenede Stater, 30342-1701
- CCOP - Atlanta Regional
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Columbus, Georgia, Forenede Stater, 31904
- John B. Amos Community Cancer Center
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Rome, Georgia, Forenede Stater, 30165
- Regional Radiation Oncology Center at Rome
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96813
- MBCCOP - Hawaii
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Illinois
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Arlington Heights, Illinois, Forenede Stater, 60005
- Northwest Community Hospital
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Chicago, Illinois, Forenede Stater, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
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Decatur, Illinois, Forenede Stater, 62526
- CCOP - Central Illinois
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Harvey, Illinois, Forenede Stater, 60426
- Ingalls Cancer Care Center at Ingalls Memorial Hospital
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Maywood, Illinois, Forenede Stater, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Park Ridge, Illinois, Forenede Stater, 60068
- Lutheran General Cancer Care Center
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Peoria, Illinois, Forenede Stater, 61636
- Methodist Medical Center of Illinois
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Indiana
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Anderson, Indiana, Forenede Stater, 46016
- St. John's Cancer Center at St. John's Medical Center
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Bloomington, Indiana, Forenede Stater, 47402
- Bloomington Hospital
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Indianapolis, Indiana, Forenede Stater, 46202
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
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Indianapolis, Indiana, Forenede Stater, 46206-1367
- Methodist Cancer Center at Methodist Hospital
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Lafayette, Indiana, Forenede Stater, 47904
- Oncology Institute of Greater Lafayette
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Muncie, Indiana, Forenede Stater, 47303-3499
- Cancer Center at Ball Memorial Hospital
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South Bend, Indiana, Forenede Stater, 46601
- CCOP - Northern Indiana CR Consortium
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Iowa
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Dubuque, Iowa, Forenede Stater, 52001
- Wendt Regional Cancer Center at Finley Hospital
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Kentucky
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Edgewood, Kentucky, Forenede Stater, 41017
- Esther Marie Hatton Cancer Care Center at St. Elizabeth Medical Center
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Lexington, Kentucky, Forenede Stater, 40503
- Central Baptist Hospital
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Lexington, Kentucky, Forenede Stater, 40536-0293
- Markey Cancer Center at University of Kentucky Chandler Medical Center
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Lexington, Kentucky, Forenede Stater, 40504
- Cancer Center at Lexington Clinic
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Louisville, Kentucky, Forenede Stater, 40202
- James Graham Brown Cancer Center at University of Louisville
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Louisville, Kentucky, Forenede Stater, 40215
- Louisville Radiation Oncology Center at Caritas Regional Cancer Center
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Madisonville, Kentucky, Forenede Stater, 42431
- Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
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Louisiana
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Baton Rouge, Louisiana, Forenede Stater, 70809-3482
- Mary Bird Perkins Cancer Center - Baton Rouge
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New Orleans, Louisiana, Forenede Stater, 70121
- CCOP - Ochsner
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New Orleans, Louisiana, Forenede Stater, 70112
- MBCCOP - LSU Health Sciences Center
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New Orleans, Louisiana, Forenede Stater, 70112-2699
- Tulane Cancer Center at Tulane University Hospital and Clinic
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Maine
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Portland, Maine, Forenede Stater, 04102
- Maine Medical Center - Bramhall Campus
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Maryland
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Annapolis, Maryland, Forenede Stater, 21401
- DeCesaris Cancer Institute at Anne Arundel Medical Center
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Baltimore, Maryland, Forenede Stater, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore, Maryland, Forenede Stater, 21215
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
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Baltimore, Maryland, Forenede Stater, 21201
- Greenebaum Cancer Center at University of Maryland Medical Center
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Baltimore, Maryland, Forenede Stater, 21215-1290
- Harbor Hospital Center
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Baltimore, Maryland, Forenede Stater, 21229
- St. Agnes Cancer Center
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Baltimore, Maryland, Forenede Stater, 21204
- Cancer Center At Greater Baltimore Medical Center
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Salisbury, Maryland, Forenede Stater, 21801
- Peninsula Regional Medical Center
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02118
- Cancer Research Center at Boston Medical Center
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Boston, Massachusetts, Forenede Stater, 02114
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Hyannis, Massachusetts, Forenede Stater, 02601
- Cape Cod Hospital
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Jamaica Plain, Massachusetts, Forenede Stater, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Peabody, Massachusetts, Forenede Stater, 01960
- NSMC Cancer Center - Peabody
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48106
- CCOP - Michigan Cancer Research Consortium
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Ann Arbor, Michigan, Forenede Stater, 48109-0010
- University Of Michigan Comprehensive Cancer Center
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Detroit, Michigan, Forenede Stater, 48201
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, Forenede Stater, 48202
- Josephine Ford Cancer Center at Henry Ford Health System
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Flint, Michigan, Forenede Stater, 48532-3685
- Great Lakes Cancer Institute at McLaren Regional Medical Center
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Kalamazoo, Michigan, Forenede Stater, 49007-3731
- CCOP - Kalamazoo
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Marquette, Michigan, Forenede Stater, 49855
- Upper Michigan Cancer Center at Marquette General Hospital
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Midland, Michigan, Forenede Stater, 48670
- MidMichigan Medical Center - Midland
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Royal Oak, Michigan, Forenede Stater, 48073
- William Beaumont Hospital - Royal Oak Campus
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Royal Oak, Michigan, Forenede Stater, 48073-6769
- CCOP - Beaumont
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Troy, Michigan, Forenede Stater, 48085
- William Beaumont Hospital - Troy Campus
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55455
- Fairview University Medical Center - University Campus
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Rochester, Minnesota, Forenede Stater, 55905-0001
- Mayo Clinic Cancer Center
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Saint Louis Park, Minnesota, Forenede Stater, 55416
- CCOP - Metro-Minnesota
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Missouri
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Columbia, Missouri, Forenede Stater, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Kansas City, Missouri, Forenede Stater, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Forenede Stater, 63110-0250
- Saint Louis University Cancer Center
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Springfield, Missouri, Forenede Stater, 65807
- CCOP - Cancer Research for the Ozarks
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St. Louis, Missouri, Forenede Stater, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital
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Montana
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Billings, Montana, Forenede Stater, 59101
- CCOP - Montana Cancer Consortium
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, Forenede Stater, 68114-4199
- Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
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Omaha, Nebraska, Forenede Stater, 68198-7521
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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Manchester, New Hampshire, Forenede Stater, 03103
- Elliot Regional Cancer Center
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New Jersey
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East Orange, New Jersey, Forenede Stater, 07018
- Veterans Affairs Medical Center - East Orange
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Edison, New Jersey, Forenede Stater, 08818
- John F. Kennedy Medical Center
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Long Branch, New Jersey, Forenede Stater, 07740-6395
- Monmouth Medical Center
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Mount Holly, New Jersey, Forenede Stater, 08060
- Fox Chase Virtua Health Cancer Program - Marlton
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New Brunswick, New Jersey, Forenede Stater, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Newark, New Jersey, Forenede Stater, 07112
- Newark Beth Israel Medical Center
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Pomona, New Jersey, Forenede Stater, 08240
- Atlantic City Medical Center - Mainland Division
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Princeton, New Jersey, Forenede Stater, 08540
- University Medical Center at Princeton
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Ridgewood, New Jersey, Forenede Stater, 07450
- Valley Hospital - Ridgewood
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Toms River, New Jersey, Forenede Stater, 08755
- Community Medical Center
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Trenton, New Jersey, Forenede Stater, 08629
- Fox Chase Cancer Center at St. Francis Medical Center
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Vineland, New Jersey, Forenede Stater, 08360
- South Jersey Healthcare Regional Cancer Center
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Warren, New Jersey, Forenede Stater, 07059
- Associated Radiologists, P.A. at Warren Radiation Therapy Center
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87109
- Radiation Oncology Associates, PA
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New York
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Binghamton, New York, Forenede Stater, 13905
- Lourdes Regional Cancer Center
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Brooklyn, New York, Forenede Stater, 11203
- SUNY Downstate Medical Center
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Brooklyn, New York, Forenede Stater, 11215-3609
- New York Methodist Hospital
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Clifton Springs, New York, Forenede Stater, 14432
- Finger Lakes Radiation Oncology Center at Clifton Springs Hospital and clinic
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East Syracuse, New York, Forenede Stater, 13057
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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Manhasset, New York, Forenede Stater, 11030
- CCOP - North Shore University Hospital
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New York, New York, Forenede Stater, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Forenede Stater, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University
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New York, New York, Forenede Stater, 10003
- Beth Israel Medical Center - Philipps Ambulatory Care Center
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Plattsburgh, New York, Forenede Stater, 12901-1490
- Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center
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Rochester, New York, Forenede Stater, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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Setauket, New York, Forenede Stater, 11733
- North Shore Radiation Oncology
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Syracuse, New York, Forenede Stater, 13210
- SUNY Upstate Medical University Hospital
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Yonkers, New York, Forenede Stater, 10701
- Riverhill Radiation Oncology
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Concord, North Carolina, Forenede Stater, 28025
- Batte Cancer Center at Northeast Medical Center
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Goldsboro, North Carolina, Forenede Stater, 27534-9479
- CCOP - Southeast Cancer Control Consortium
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Greenville, North Carolina, Forenede Stater, 27835-6028
- Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
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Winston-Salem, North Carolina, Forenede Stater, 27157-1096
- Comprehensive Cancer Center at Wake Forest University
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North Dakota
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Minot, North Dakota, Forenede Stater, 58701
- Trinity Cancer Care Center
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Ohio
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Akron, Ohio, Forenede Stater, 44304
- Akron City Hospital at Summa Health System
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Akron, Ohio, Forenede Stater, 44302
- McDowell Cancer Center at Akron General Medical Center
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Cincinnati, Ohio, Forenede Stater, 45219
- Cancer Center at Christ Hospital
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Cincinnati, Ohio, Forenede Stater, 45219
- Charles M. Barrett Cancer Center at University Hospital
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Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Forenede Stater, 44106-5047
- Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
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Columbus, Ohio, Forenede Stater, 43210-1240
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
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Columbus, Ohio, Forenede Stater, 43206
- CCOP - Columbus
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Dayton, Ohio, Forenede Stater, 45429
- CCOP - Dayton
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Parma, Ohio, Forenede Stater, 44129
- Parma Community General Hospital
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Toledo, Ohio, Forenede Stater, 43623-3456
- CCOP - Toledo Community Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- Oklahoma University Medical Center
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Oklahoma City, Oklahoma, Forenede Stater, 73102
- Frank C. Love Cancer Institute at St. Anthony Hospital
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Tulsa, Oklahoma, Forenede Stater, 74136
- CCOP - Oklahoma
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Tulsa, Oklahoma, Forenede Stater, 74104
- LaFortune Cancer Center at St. John Health System
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Oregon
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Portland, Oregon, Forenede Stater, 97225
- CCOP - Columbia River Oncology Program
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Pennsylvania
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Abington, Pennsylvania, Forenede Stater, 19001
- Abington Memorial Hospital
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Allentown, Pennsylvania, Forenede Stater, 18105-1556
- John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
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Bethlehem, Pennsylvania, Forenede Stater, 18015
- St. Luke's Hospital Cancer Center
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Danville, Pennsylvania, Forenede Stater, 17822-2001
- Geisinger Medical Center
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Darby, Pennsylvania, Forenede Stater, 19023
- Mercy Fitzgerald Hospital
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Drexel Hill, Pennsylvania, Forenede Stater, 19026
- Delaware County Regional Cancer Center at Delaware County Memorial Hospital
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East Stroudsburg, Pennsylvania, Forenede Stater, 18301
- Dale and Frances Hughes Cancer Center at Pocono Medical Center
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Hershey, Pennsylvania, Forenede Stater, 17033
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Forenede Stater, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, Forenede Stater, 19104-4283
- Abramson Cancer Center of the University of Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19107-5541
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
-
Philadelphia, Pennsylvania, Forenede Stater, 19141-3098
- Albert Einstein Cancer Center
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Pittsburgh, Pennsylvania, Forenede Stater, 15224
- Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
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Pittsburgh, Pennsylvania, Forenede Stater, 15219
- Mercy Hospital of Pittsburgh
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Pittsburgh, Pennsylvania, Forenede Stater, 15232
- Hillman Cancer Center at University of Pittsburgh Cancer Institute
-
Pittsburgh, Pennsylvania, Forenede Stater, 15212-4772
- Allegheny Cancer Center at Allegheny General Hospital
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Reading, Pennsylvania, Forenede Stater, 19612-6052
- Reading Hospital and Medical Center
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Scranton, Pennsylvania, Forenede Stater, 18501
- Mercy Hospital Cancer Center - Scranton
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Wilkes-Barre, Pennsylvania, Forenede Stater, 18764-0001
- Wilkes-Barre General Hospital
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Wynnewood, Pennsylvania, Forenede Stater, 19096
- CCOP - MainLine Health
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York, Pennsylvania, Forenede Stater, 17403
- York Cancer Center at Wellspan Health
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02908-4735
- Roger Williams Medical Center
-
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South Carolina
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Greenville, South Carolina, Forenede Stater, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, Forenede Stater, 29303
- CCOP - Upstate Carolina
-
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South Dakota
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Rapid City, South Dakota, Forenede Stater, 57709
- Rapid City Regional Hospital
-
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Tennessee
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Jackson, Tennessee, Forenede Stater, 38301
- West Tennessee Cancer Center at Jackson-Madison County General Hospital
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Nashville, Tennessee, Forenede Stater, 37232-5671
- Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
-
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Texas
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Amarillo, Texas, Forenede Stater, 79106
- Harrington Cancer Center
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Arlington, Texas, Forenede Stater, 76012
- Arlington Cancer Center - Arlington
-
Galveston, Texas, Forenede Stater, 77555-0209
- University of Texas Medical Branch
-
Houston, Texas, Forenede Stater, 77030-4009
- M.D. Anderson Cancer Center at University of Texas
-
Lackland Air Force Base, Texas, Forenede Stater, 78236-5300
- Wilford Hall Medical Center
-
Lubbock, Texas, Forenede Stater, 79410
- Joe Arrington Cancer Research and Treatment Center
-
San Antonio, Texas, Forenede Stater, 78284-7811
- University of Texas Health Science Center at San Antonio
-
Temple, Texas, Forenede Stater, 76508
- CCOP - Scott and White Hospital
-
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Utah
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Provo, Utah, Forenede Stater, 84604
- Utah Valley Regional Medical Center - Provo
-
Saint George, Utah, Forenede Stater, 84770
- Dixie Regional Medical Center
-
Salt Lake City, Utah, Forenede Stater, 84132
- University of Utah Health Sciences Center
-
Salt Lake City, Utah, Forenede Stater, 84143
- LDS Hospital
-
-
Vermont
-
Burlington, Vermont, Forenede Stater, 05405-0075
- Vermont Cancer Center at University of Vermont
-
Rutland, Vermont, Forenede Stater, 05701
- Community Cancer Center at Rutland Regional Medical Center
-
-
Virginia
-
Charlottesville, Virginia, Forenede Stater, 22908
- Cancer Center at the University of Virginia
-
Harrisonburg, Virginia, Forenede Stater, 22801
- RMH Regional Cancer Center
-
Portsmouth, Virginia, Forenede Stater, 23708-1912
- Naval Medical Center - Portsmouth
-
Richmond, Virginia, Forenede Stater, 23226
- Bon Secours Cancer Care at St. Mary's Hospital
-
Richmond, Virginia, Forenede Stater, 23298-0058
- Massey Cancer Center at Virginia Commonwealth University
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98111
- Cancer Institute at Virginia Mason Medical Center
-
Spokane, Washington, Forenede Stater, 99204
- Deaconess Medical Center
-
Yakima, Washington, Forenede Stater, 98902
- Yakima Valley Memorial Hospital
-
-
West Virginia
-
Wheeling, West Virginia, Forenede Stater, 26003
- Schiffler Cancer Center at Wheeling Hospital
-
-
Wisconsin
-
Green Bay, Wisconsin, Forenede Stater, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
-
Green Bay, Wisconsin, Forenede Stater, 54307-3508
- St. Vincent Hospital
-
La Crosse, Wisconsin, Forenede Stater, 54601
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
-
Madison, Wisconsin, Forenede Stater, 53792
- University of Wisconsin Comprehensive Cancer Center
-
Marshfield, Wisconsin, Forenede Stater, 54449
- Marshfield Clinic - Marshfield Center
-
Marshfield, Wisconsin, Forenede Stater, 54449
- CCOP - Marshfield Clinic Research Foundation
-
Menomonee Falls, Wisconsin, Forenede Stater, 53051
- Community Memorial Hospital
-
Milwaukee, Wisconsin, Forenede Stater, 53295
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
-
Milwaukee, Wisconsin, Forenede Stater, 53211
- Columbia St. Mary's - Columbia Campus
-
Milwaukee, Wisconsin, Forenede Stater, 53215
- Vince Lombardi Cancer Clinic at St. Luke's Medical Center
-
Racine, Wisconsin, Forenede Stater, 53405
- All Saints Cancer Center at All Saints Healthcare
-
Waukesha, Wisconsin, Forenede Stater, 53188
- Waukesha Memorial Hospital Regional Cancer Center
-
-
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
13 år til 116 år (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
SYGDOMS KARAKTERISTIKA:
Histologisk eller cytologisk bekræftet solid tumor eller lymfom uden leukæmi
- Stadium III eller IV eller ethvert andet stadie forbundet med nuværende metastatisk sygdom ved præsentationen
- Ingen primære eller metastatiske hjernetumorer
- Vægttab på mindst 2 % men ikke mere end 10 % inden for de seneste 3 måneder
- Ingen ascites
PATIENT KARAKTERISTIKA:
Alder
- 17 og derover
Præstationsstatus
- Zubrod 0-2
Forventede levealder
- Mindst 3 måneder
Hæmatopoietisk
- Ikke specificeret
Hepatisk
- Ikke specificeret
Renal
- Ingen hypercalcæmi
Kardiovaskulær
- Intet vedvarende moderat eller alvorligt perifert ødem
- Ingen ukontrolleret kongestiv hjertesvigt
Gastrointestinale
- Ingen enterisk fistel
Ingen samtidig intestinal obstruktion
- Forudgående tarmobstruktion tilladt
Andet
- Ikke gravid eller ammende
- Negativ graviditetstest
- Ingen ukontrollerede infektioner
- Ingen anden alvorlig medicinsk sygdom
- Ingen stofskifteforstyrrelser
FORUDSÆTNING SAMTYDLIG TERAPI:
Biologisk terapi
- Ikke specificeret
Kemoterapi
- Samtidig kemoterapi tilladt
Endokrin terapi
- Ingen dexamethason som appetitstimulerende middel
- Intermitterende dexamethason under samtidig kemoterapi tilladt
Strålebehandling
- Samtidig strålebehandling tilladt
Kirurgi
- Mindst 1 uge siden tidligere mindre operation
- Mindst 3 uger siden tidligere større operation
Andet
- Mindst 30 dage siden forudgående total parenteral ernæring
- Ingen samtidig parenteral fodring
- Ingen kendte samtidige appetitstimulerende midler (f.eks. megestrol eller dronabinol)
- Ingen samtidige omega 3-fedtsyrer eller deres congenere (f.eks. ProSure™)
- Ingen samtidige aminosyretilskud
- Samtidig brug af andre kosttilskud (f.eks. Ensure® eller Boost) er tilladt
- Samtidig enteral ernæring via PEG eller nasogastrisk sonde er tilladt
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: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Juven tillæg
Juven ernæringstilskud givet to gange dagligt i 8 uger
|
|
|
Aktiv komparator: Ikke-ungdomstillæg
Ikke-juven kosttilskud givet to gange dagligt i 8 uger
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Mager kropsmasse
Tidsramme: Studieadgang til 8 uger
|
Studieadgang til 8 uger
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Træthed
Tidsramme: Studieadgang til 8 uger
|
Studieadgang til 8 uger
|
|
Livskvalitet
Tidsramme: Studieadgang til 8 uger
|
Studieadgang til 8 uger
|
|
Kropsvægt
Tidsramme: Studieadgang til 8 uger
|
Studieadgang til 8 uger
|
|
Korrelation mellem ændring i mager kropsmasse og kropsplethysmografi, bioimpedans og hudfoldsmåling
Tidsramme: Studieadgang til 8 uger
|
Studieadgang til 8 uger
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Lawrence B. Berk, MD, PhD, CCOP - Columbus
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.
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 2002
Primær færdiggørelse (Faktiske)
1. marts 2005
Studieafslutning (Faktiske)
1. februar 2009
Datoer for studieregistrering
Først indsendt
27. januar 2003
Først indsendt, der opfyldte QC-kriterier
27. januar 2003
Først opslået (Skøn)
28. januar 2003
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
8. december 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. december 2016
Sidst verificeret
1. oktober 2013
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- uspecificeret voksen solid tumor, protokol specifik
- stadium III voksent diffust storcellet lymfom
- stadium III voksen immunoblastisk storcellet lymfom
- stadium III voksen Burkitt lymfom
- stadium IV grad 3 follikulært lymfom
- stadium IV voksent diffust storcellet lymfom
- stadium IV voksen immunoblastisk storcellet lymfom
- stadium IV voksen Burkitt lymfom
- tilbagevendende grad 3 follikulært lymfom
- tilbagevendende voksent diffust storcellet lymfom
- tilbagevendende voksen immunoblastisk storcellet lymfom
- recidiverende voksen Burkitt lymfom
- AIDS-relateret perifert/systemisk lymfom
- recidiverende voksen Hodgkin lymfom
- recidiverende voksent diffust små spaltet celle lymfom
- recidiverende voksent diffust blandet celle lymfom
- kakeksi
- stadium III grad 1 follikulært lymfom
- stadium III grad 2 follikulært lymfom
- stadium III grad 3 follikulært lymfom
- stadium III voksent diffust små spaltet celle lymfom
- stadium III voksent diffust blandet celle lymfom
- stadium IV grad 1 follikulært lymfom
- stadium IV grad 2 follikulært lymfom
- stadium IV voksent diffust små spaltet celle lymfom
- stadium IV voksent diffust blandet celle lymfom
- stadium III mantelcellelymfom
- stadium IV mantelcellelymfom
- tilbagevendende grad 1 follikulært lymfom
- tilbagevendende grad 2 follikulært lymfom
- tilbagevendende marginal zone lymfom
- tilbagevendende lille lymfocytisk lymfom
- stadium III lille lymfatisk lymfom
- stadium III marginal zone lymfom
- stadium IV lille lymfocytisk lymfom
- stadium IV marginal zone lymfom
- ekstranodal marginal zone B-celle lymfom af slimhinde-associeret lymfoid væv
- nodal marginal zone B-celle lymfom
- milt marginal zone lymfom
- tilbagevendende lymfoblastisk lymfom hos voksne
- tilbagevendende kappecellelymfom
- stadium III voksen Hodgkin lymfom
- stadium IV voksen Hodgkin lymfom
- stadium III kutant T-celle non-Hodgkin lymfom
- stadium IV kutant T-celle non-Hodgkin lymfom
- tilbagevendende kutant T-celle non-Hodgkin lymfom
- stadium III voksen lymfoblastisk lymfom
- stadium IV voksen lymfoblastisk lymfom
- intraokulært lymfom
- anaplastisk storcellet lymfom
- post-transplantation lymfoproliferativ lidelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RTOG-0122
- CDR0000269100
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 .