Comparison of Nutritional Supplements in Preventing Weight Loss in Patients With Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00053053
First received: January 27, 2003
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

RATIONALE: Nutritional supplements may help prevent loss of appetite, weight loss, and fatigue in patients with advanced cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two nutritional supplements in preventing loss of appetite, weight loss, and fatigue in patients who have stage III or stage IV solid tumors.


Condition Intervention Phase
Cachexia
Lymphoma
Lymphoproliferative Disorder
Unspecified Adult Solid Tumor, Protocol Specific
Dietary Supplement: Juven
Dietary Supplement: Non-Juven Supplement
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Double-Blind Study Of Nutritional Intervention For The Treatment Of Cancer Cachexia Using Juven® Nutritional Supplement

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Lean body mass [ Time Frame: Study entry to 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fatigue [ Time Frame: Study entry to 8 weeks ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: Study entry to 8 weeks ] [ Designated as safety issue: No ]
  • Body weight [ Time Frame: Study entry to 8 weeks ] [ Designated as safety issue: No ]
  • Correlation between change in lean body mass and body plethysmography, bioimpedance and skin-fold measurement [ Time Frame: Study entry to 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 472
Study Start Date: December 2002
Study Completion Date: February 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Juven supplement
Juven nutritional supplement given twice a day for 8 weeks
Dietary Supplement: Juven
Active Comparator: Non-Juven supplement
Non-Juven nutritional supplement given twice a day for 8 weeks
Dietary Supplement: Non-Juven Supplement

Detailed Description:

OBJECTIVES:

  • Compare the change in lean body mass of patients treated with Juven® vs a non-Juven® supplement.
  • Compare the change in fatigue and quality of life of patients treated with these supplements.
  • Compare the results of plethysmography, bioimpedance, and skinfold measurement in patients treated with these supplements.
  • Compare the weight change in patients treated with these supplements.

OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to primary disease site (lung vs others), concurrent chemotherapy (yes vs no), evidence of metastases (yes vs no), and degree of weight loss (2-5% vs 6-10%). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral Juven® supplement twice daily for 8 weeks.
  • Arm II: Patients receive oral non-Juven® supplement twice daily for 8 weeks. All patients undergo lean body mass measurement (to include multiple body composition and weight change) and fatigue and quality of life assessments at baseline and then at 4 and 8 weeks.

PROJECTED ACCRUAL: A total of 468 patients (234 per treatment arm) will be accrued for this study within 16 months.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed solid tumor or lymphoma with no leukemic aspect

    • Stage III or IV or any other stage associated with current metastatic disease at presentation
    • No primary or metastatic brain tumors
  • Weight loss of at least 2% but no more than 10% within the past 3 months
  • No ascites

PATIENT CHARACTERISTICS:

Age

  • 17 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • At least 3 months

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • No hypercalcemia

Cardiovascular

  • No persistent moderate or severe peripheral edema
  • No uncontrolled congestive heart failure

Gastrointestinal

  • No enteric fistula
  • No concurrent intestinal obstruction

    • Prior intestinal obstruction allowed

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • No uncontrolled infections
  • No other serious medical illness
  • No metabolic disorder

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Concurrent chemotherapy allowed

Endocrine therapy

  • No dexamethasone as an appetite stimulant
  • Intermittent dexamethasone during concurrent chemotherapy allowed

Radiotherapy

  • Concurrent radiotherapy allowed

Surgery

  • At least 1 week since prior minor surgery
  • At least 3 weeks since prior major surgery

Other

  • At least 30 days since prior total parenteral nutrition
  • No concurrent parenteral feedings
  • No concurrent known appetite stimulants (e.g., megestrol or dronabinol)
  • No concurrent omega 3 fatty acids or their congeners (e.g., ProSure™)
  • No concurrent amino acid supplements
  • Concurrent use of other dietary supplements (e.g., Ensure® or Boost) is allowed
  • Concurrent enteral feedings via PEG or nasogastric tube are allowed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053053

  Hide Study Locations
Locations
United States, Alabama
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
Comprehensive Cancer Institute
Huntsville, Alabama, United States, 35801
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36607
Montgomery Cancer Center
Montgomery, Alabama, United States, 36106-3657
DCH Cancer Treatment Center
Tuscaloosa, Alabama, United States, 35401
United States, Arizona
Foundation for Cancer Research and Education
Phoenix, Arizona, United States, 85013
United States, California
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
Mount Diablo Regional Cancer Center
Concord, California, United States, 94524-4110
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
California Cancer Center - Woodward Park Office
Fresno, California, United States, 93720
Saint Agnes Cancer Center
Fresno, California, United States, 93720
Sutter Health Western Division Cancer Research Group
Greenbrae, California, United States, 94904
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Veterans Affairs Medical Center - Long Beach
Long Beach, California, United States, 90822
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1714
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
Huntington Cancer Center at Huntington Hospital
Pasadena, California, United States, 91105
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
Pomona, California, United States, 91767
Radiation Oncology Centers - Sacramento
Sacramento, California, United States, 95815
Naval Medical Center - San Diego
San Diego, California, United States, 92134-3202
Radiation Medical Group, Incorporated
San Diego, California, United States, 92101-1492
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
O'Connor Hospital
San Jose, California, United States, 95128
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States, 95403
St. Joseph's Regional Cancer Center
Stockton, California, United States, 95204
Torrance Memorial Medical Center
Torrance, California, United States, 90505
General Robert Huyser Cancer Center at David Grant Medical Center
Travis Air Force Base, California, United States, 94535
United States, Colorado
Memorial Hospital Cancer Center
Colorado Springs, Colorado, United States, 80909
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, United States, 80010
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, United States, 81502-1628
United States, Connecticut
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06520-8040
Hospital of Saint Raphael
New Haven, Connecticut, United States, 06511
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, District of Columbia
Sibley Memorial Hospital
Washington, District of Columbia, United States, 20016
United States, Florida
21st Century Oncology - Fort Myers
Fort Myers, Florida, United States, 33901-8082
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0385
Florida Radiation Oncology Group
Jacksonville, Florida, United States, 32207
Holmes Regional Medical Center
Melbourne, Florida, United States, 32901-3276
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Baptist-South Miami Regional Cancer Program
Miami, Florida, United States, 33176-2197
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Bay Medical Center
Panama City, Florida, United States, 32401
Gulf Coast Cancer Treatment Center
Panama City, Florida, United States, 32405-4587
Sarasota Radiation and Medical Oncology Center
Sarasota, Florida, United States, 34233
Tallahassee Memorial Hospital
Tallahassee, Florida, United States, 32308
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
United States, Georgia
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342-1701
John B. Amos Community Cancer Center
Columbus, Georgia, United States, 31904
Regional Radiation Oncology Center at Rome
Rome, Georgia, United States, 30165
United States, Hawaii
MBCCOP - Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
Northwest Community Hospital
Arlington Heights, Illinois, United States, 60005
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
United States, Indiana
St. John's Cancer Center at St. John's Medical Center
Anderson, Indiana, United States, 46016
Bloomington Hospital
Bloomington, Indiana, United States, 47402
Methodist Cancer Center at Methodist Hospital
Indianapolis, Indiana, United States, 46206-1367
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States, 46202
Oncology Institute of Greater Lafayette
Lafayette, Indiana, United States, 47904
Cancer Center at Ball Memorial Hospital
Muncie, Indiana, United States, 47303-3499
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
United States, Iowa
Wendt Regional Cancer Center at Finley Hospital
Dubuque, Iowa, United States, 52001
United States, Kentucky
Esther Marie Hatton Cancer Care Center at St. Elizabeth Medical Center
Edgewood, Kentucky, United States, 41017
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536-0293
Cancer Center at Lexington Clinic
Lexington, Kentucky, United States, 40504
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States, 40202
Louisville Radiation Oncology Center at Caritas Regional Cancer Center
Louisville, Kentucky, United States, 40215
Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
Madisonville, Kentucky, United States, 42431
United States, Louisiana
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, United States, 70809-3482
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
Tulane Cancer Center at Tulane University Hospital and Clinic
New Orleans, Louisiana, United States, 70112-2699
United States, Maine
Maine Medical Center - Bramhall Campus
Portland, Maine, United States, 04102
United States, Maryland
DeCesaris Cancer Institute at Anne Arundel Medical Center
Annapolis, Maryland, United States, 21401
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Harbor Hospital Center
Baltimore, Maryland, United States, 21215-1290
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
St. Agnes Cancer Center
Baltimore, Maryland, United States, 21229
Cancer Center at Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, United States, 21215
Peninsula Regional Medical Center
Salisbury, Maryland, United States, 21801
United States, Massachusetts
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States, 02118
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02114
Cape Cod Hospital
Hyannis, Massachusetts, United States, 02601
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, United States, 02130
NSMC Cancer Center - Peabody
Peabody, Massachusetts, United States, 01960
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0010
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Josephine Ford Cancer Center at Henry Ford Health System
Detroit, Michigan, United States, 48202
Great Lakes Cancer Institute at McLaren Regional Medical Center
Flint, Michigan, United States, 48532-3685
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
Upper Michigan Cancer Center at Marquette General Hospital
Marquette, Michigan, United States, 49855
MidMichigan Medical Center - Midland
Midland, Michigan, United States, 48670
CCOP - Beaumont
Royal Oak, Michigan, United States, 48073-6769
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
William Beaumont Hospital - Troy Campus
Troy, Michigan, United States, 48085
United States, Minnesota
Fairview University Medical Center - University Campus
Minneapolis, Minnesota, United States, 55455
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905-0001
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United States, Missouri
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Saint Louis University Cancer Center
Saint Louis, Missouri, United States, 63110-0250
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
Siteman Cancer Center at Barnes-Jewish Hospital
St. Louis, Missouri, United States, 63110
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7521
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha, Nebraska, United States, 68114-4199
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
Elliot Regional Cancer Center
Manchester, New Hampshire, United States, 03103
United States, New Jersey
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States, 07018
John F. Kennedy Medical Center
Edison, New Jersey, United States, 08818
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
Fox Chase Virtua Health Cancer Program - Marlton
Mount Holly, New Jersey, United States, 08060
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Atlantic City Medical Center - Mainland Division
Pomona, New Jersey, United States, 08240
University Medical Center at Princeton
Princeton, New Jersey, United States, 08540
Valley Hospital - Ridgewood
Ridgewood, New Jersey, United States, 07450
Community Medical Center
Toms River, New Jersey, United States, 08755
Fox Chase Cancer Center at St. Francis Medical Center
Trenton, New Jersey, United States, 08629
South Jersey Healthcare Regional Cancer Center
Vineland, New Jersey, United States, 08360
Associated Radiologists, P.A. at Warren Radiation Therapy Center
Warren, New Jersey, United States, 07059
United States, New Mexico
Radiation Oncology Associates, PA
Albuquerque, New Mexico, United States, 87109
United States, New York
Lourdes Regional Cancer Center
Binghamton, New York, United States, 13905
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
New York Methodist Hospital
Brooklyn, New York, United States, 11215-3609
Finger Lakes Radiation Oncology Center at Clifton Springs Hospital and clinic
Clifton Springs, New York, United States, 14432
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
East Syracuse, New York, United States, 13057
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Beth Israel Medical Center - Philipps Ambulatory Care Center
New York, New York, United States, 10003
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center
Plattsburgh, New York, United States, 12901-1490
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
North Shore Radiation Oncology
Setauket, New York, United States, 11733
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
Riverhill Radiation Oncology
Yonkers, New York, United States, 10701
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Batte Cancer Center at Northeast Medical Center
Concord, North Carolina, United States, 28025
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States, 27534-9479
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
Greenville, North Carolina, United States, 27835-6028
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1096
United States, North Dakota
Trinity Cancer Care Center
Minot, North Dakota, United States, 58701
United States, Ohio
Akron City Hospital at Summa Health System
Akron, Ohio, United States, 44304
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States, 44302
Cancer Center at Christ Hospital
Cincinnati, Ohio, United States, 45219
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45219
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland, Ohio, United States, 44106-5047
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210-1240
CCOP - Columbus
Columbus, Ohio, United States, 43206
CCOP - Dayton
Dayton, Ohio, United States, 45429
Parma Community General Hospital
Parma, Ohio, United States, 44129
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43623-3456
United States, Oklahoma
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States, 73104
Frank C. Love Cancer Institute at St. Anthony Hospital
Oklahoma City, Oklahoma, United States, 73102
CCOP - Oklahoma
Tulsa, Oklahoma, United States, 74136
LaFortune Cancer Center at St. John Health System
Tulsa, Oklahoma, United States, 74104
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18105-1556
St. Luke's Hospital Cancer Center
Bethlehem, Pennsylvania, United States, 18015
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Mercy Fitzgerald Hospital
Darby, Pennsylvania, United States, 19023
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
Dale and Frances Hughes Cancer Center at Pocono Medical Center
East Stroudsburg, Pennsylvania, United States, 18301
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141-3098
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212-4772
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15219
Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, United States, 18501
Wilkes-Barre General Hospital
Wilkes-Barre, Pennsylvania, United States, 18764-0001
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
York Cancer Center at Wellspan Health
York, Pennsylvania, United States, 17403
United States, Rhode Island
Roger Williams Medical Center
Providence, Rhode Island, United States, 02908-4735
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57709
United States, Tennessee
West Tennessee Cancer Center at Jackson-Madison County General Hospital
Jackson, Tennessee, United States, 38301
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232-5671
United States, Texas
Harrington Cancer Center
Amarillo, Texas, United States, 79106
Arlington Cancer Center - Arlington
Arlington, Texas, United States, 76012
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0209
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States, 78236-5300
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Utah
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
Dixie Regional Medical Center
Saint George, Utah, United States, 84770
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132
LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Vermont
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States, 05405-0075
Community Cancer Center at Rutland Regional Medical Center
Rutland, Vermont, United States, 05701
United States, Virginia
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
RMH Regional Cancer Center
Harrisonburg, Virginia, United States, 22801
Naval Medical Center - Portsmouth
Portsmouth, Virginia, United States, 23708-1912
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0058
Bon Secours Cancer Care at St. Mary's Hospital
Richmond, Virginia, United States, 23226
United States, Washington
Cancer Institute at Virginia Mason Medical Center
Seattle, Washington, United States, 98111
Deaconess Medical Center
Spokane, Washington, United States, 99204
Yakima Valley Memorial Hospital
Yakima, Washington, United States, 98902
United States, West Virginia
Schiffler Cancer Center at Wheeling Hospital
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
St. Vincent Hospital
Green Bay, Wisconsin, United States, 54307-3508
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States, 54301
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
Community Memorial Hospital
Menomonee Falls, Wisconsin, United States, 53051
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States, 53295
Vince Lombardi Cancer Clinic at St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Columbia St. Mary's - Columbia Campus
Milwaukee, Wisconsin, United States, 53211
All Saints Cancer Center at All Saints Healthcare
Racine, Wisconsin, United States, 53405
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, United States, 53188
Canada, Alberta
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, New Brunswick
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, Canada, E1C 8X3
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Cancer Centre of Southeastern Ontario
Kingston, Ontario, Canada, K7L 5P9
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Northeastern Ontario Regional Cancer Centre
Sudbury, Ontario, Canada, P3E 5J1
Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada, P7B 6V4
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2L 4MI
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada, H2W 1S6
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6
CHUS-Hopital Fleurimont
Sherbrooke, Quebec, Canada, J1H 5N4
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Lawrence B. Berk, MD, PhD CCOP - Columbus
  More Information

Additional Information:
Publications:
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00053053     History of Changes
Other Study ID Numbers: RTOG-0122, CDR0000269100
Study First Received: January 27, 2003
Last Updated: October 8, 2013
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
unspecified adult solid tumor, protocol specific
cachexia
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult Hodgkin lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
stage III adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult Burkitt lymphoma
stage III adult Hodgkin lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III mantle cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult Burkitt lymphoma
stage IV adult Hodgkin lymphoma

Additional relevant MeSH terms:
Cachexia
Lymphoma
Lymphoproliferative Disorders
Body Weight
Body Weight Changes
Emaciation
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Neoplasms
Neoplasms by Histologic Type
Signs and Symptoms
Weight Loss

ClinicalTrials.gov processed this record on October 29, 2014