CachexiaPhase 3NCT00053053
Comparison of Nutritional Supplements in Preventing Weight Loss in Patients With Cancer
A Phase 3 study testing Juven and Non-Juven Supplement in people with Cachexia and Lymphoma, run by Radiation Therapy Oncology Group at 250 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 17 to 120 years
- Conditions the study is for
- Cachexia, Lymphoma, Lymphoproliferative Disorder
- What is being tested?
- Juven and Non-Juven Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 472 participants
- Where
- 250 sitesin 2 countries
- Study dates
- Dec 2002to Feb 2009
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
250 sites in 2 countries.
250 sites in 2 countries
United States230 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19001
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, 44302
Akron City Hospital at Summa Health System
Akron, Ohio, 44304
Radiation Oncology Associates, PA
Albuquerque, New Mexico, 87109
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
Allentown, Pennsylvania, 18105-1556
Harrington Cancer Center
Amarillo, Texas, 79106
St. John's Cancer Center at St. John's Medical Center
Anderson, Indiana, 46016
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0010
DeCesaris Cancer Institute at Anne Arundel Medical Center
Annapolis, Maryland, 21401
Arlington Cancer Center - Arlington
Arlington, Texas, 76012
Northwest Community Hospital
Arlington Heights, Illinois, 60005
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, 21201
Cancer Center at Greater Baltimore Medical Center
Baltimore, Maryland, 21204
Harbor Hospital Center
Baltimore, Maryland, 21215-1290
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, 21215
St. Agnes Cancer Center
Baltimore, Maryland, 21229
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, 70809-3482
St. Luke's Hospital Cancer Center
Bethlehem, Pennsylvania, 18015
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
Lourdes Regional Cancer Center
Binghamton, New York, 13905
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300
Bloomington Hospital
Bloomington, Indiana, 47402
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02114
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, 02118
SUNY Downstate Medical Center
Brooklyn, New York, 11203
New York Methodist Hospital
Brooklyn, New York, 11215-3609
Providence Saint Joseph Medical Center - Burbank
Burbank, California, 91505
Vermont Cancer Center at University of Vermont
Burlington, Vermont, 05405-0075
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013
Cancer Center at Christ Hospital
Cincinnati, Ohio, 45219
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, 45219
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland, Ohio, 44106-5047
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Finger Lakes Radiation Oncology Center at Clifton Springs Hospital and clinic
Clifton Springs, New York, 14432
Memorial Hospital Cancer Center
Colorado Springs, Colorado, 80909
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, 65203
John B. Amos Community Cancer Center
Columbus, Georgia, 31904
CCOP - Columbus
Columbus, Ohio, 43206
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, 43210-1240
Mount Diablo Regional Cancer Center
Concord, California, 94524-4110
Batte Cancer Center at Northeast Medical Center
Concord, North Carolina, 28025
Geisinger Medical Center
Danville, Pennsylvania, 17822-2001
Mercy Fitzgerald Hospital
Darby, Pennsylvania, 19023
CCOP - Dayton
Dayton, Ohio, 45429
CCOP - Central Illinois
Decatur, Illinois, 62526
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, 80010
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Josephine Ford Cancer Center at Henry Ford Health System
Detroit, Michigan, 48202
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
Wendt Regional Cancer Center at Finley Hospital
Dubuque, Iowa, 52001
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07018
Dale and Frances Hughes Cancer Center at Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
East Syracuse, New York, 13057
Esther Marie Hatton Cancer Care Center at St. Elizabeth Medical Center
Edgewood, Kentucky, 41017
John F. Kennedy Medical Center
Edison, New Jersey, 08818
Great Lakes Cancer Institute at McLaren Regional Medical Center
Flint, Michigan, 48532-3685
21st Century Oncology - Fort Myers
Fort Myers, Florida, 33901-8082
California Cancer Center - Woodward Park Office
Fresno, California, 93720
Saint Agnes Cancer Center
Fresno, California, 93720
University of Florida Shands Cancer Center
Gainesville, Florida, 32610-0385
University of Texas Medical Branch
Galveston, Texas, 77555-0209
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, 27534-9479
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, 81502-1628
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54301
St. Vincent Hospital
Green Bay, Wisconsin, 54307-3508
Sutter Health Western Division Cancer Research Group
Greenbrae, California, 94904
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
Greenville, North Carolina, 27835-6028
CCOP - Greenville
Greenville, South Carolina, 29615
RMH Regional Cancer Center
Harrisonburg, Virginia, 22801
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, 60426
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
MBCCOP - Hawaii
Honolulu, Hawaii, 96813
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009
Comprehensive Cancer Institute
Huntsville, Alabama, 35801
Cape Cod Hospital
Hyannis, Massachusetts, 02601
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202
Methodist Cancer Center at Methodist Hospital
Indianapolis, Indiana, 46206-1367
West Tennessee Cancer Center at Jackson-Madison County General Hospital
Jackson, Tennessee, 38301
Florida Radiation Oncology Group
Jacksonville, Florida, 32207
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
CCOP - Kansas City
Kansas City, Missouri, 64131
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Wilford Hall Medical Center
Lackland Air Force Base, Texas, 78236-5300
Oncology Institute of Greater Lafayette
Lafayette, Indiana, 47904
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0002
Central Baptist Hospital
Lexington, Kentucky, 40503
Cancer Center at Lexington Clinic
Lexington, Kentucky, 40504
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536-0293
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, 92354
Veterans Affairs Medical Center - Long Beach
Long Beach, California, 90822
Monmouth Medical Center
Long Branch, New Jersey, 07740-6395
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1714
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202
Louisville Radiation Oncology Center at Caritas Regional Cancer Center
Louisville, Kentucky, 40215
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
Madisonville, Kentucky, 42431
Elliot Regional Cancer Center
Manchester, New Hampshire, 03103
CCOP - North Shore University Hospital
Manhasset, New York, 11030
Upper Michigan Cancer Center at Marquette General Hospital
Marquette, Michigan, 49855
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, 54449
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, 60153
Holmes Regional Medical Center
Melbourne, Florida, 32901-3276
Community Memorial Hospital
Menomonee Falls, Wisconsin, 53051
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Baptist-South Miami Regional Cancer Program
Miami, Florida, 33176-2197
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140
MidMichigan Medical Center - Midland
Midland, Michigan, 48670
Columbia St. Mary's - Columbia Campus
Milwaukee, Wisconsin, 53211
Vince Lombardi Cancer Clinic at St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295
Fairview University Medical Center - University Campus
Minneapolis, Minnesota, 55455
Trinity Cancer Care Center
Minot, North Dakota, 58701
MBCCOP - Gulf Coast
Mobile, Alabama, 36607
Montgomery Cancer Center
Montgomery, Alabama, 36106-3657
Fox Chase Virtua Health Cancer Program - Marlton
Mount Holly, New Jersey, 08060
Cancer Center at Ball Memorial Hospital
Muncie, Indiana, 47303-3499
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, 37232-5671
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
Hospital of Saint Raphael
New Haven, Connecticut, 06511
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06520-8040
Tulane Cancer Center at Tulane University Hospital and Clinic
New Orleans, Louisiana, 70112-2699
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
CCOP - Ochsner
New Orleans, Louisiana, 70121
Beth Israel Medical Center - Philipps Ambulatory Care Center
New York, New York, 10003
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, 10032
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
Frank C. Love Cancer Institute at St. Anthony Hospital
Oklahoma City, Oklahoma, 73102
Oklahoma University Medical Center
Oklahoma City, Oklahoma, 73104
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha, Nebraska, 68114-4199
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, 68198-7521
Bay Medical Center
Panama City, Florida, 32401
Gulf Coast Cancer Treatment Center
Panama City, Florida, 32405-4587
Lutheran General Cancer Care Center
Park Ridge, Illinois, 60068
Parma Community General Hospital
Parma, Ohio, 44129
Huntington Cancer Center at Huntington Hospital
Pasadena, California, 91105
NSMC Cancer Center - Peabody
Peabody, Massachusetts, 01960
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141-3098
Foundation for Cancer Research and Education
Phoenix, Arizona, 85013
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212-4772
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15219
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232
Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center
Plattsburgh, New York, 12901-1490
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
Pomona, California, 91767
Atlantic City Medical Center - Mainland Division
Pomona, New Jersey, 08240
Maine Medical Center - Bramhall Campus
Portland, Maine, 04102
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225
Naval Medical Center - Portsmouth
Portsmouth, Virginia, 23708-1912
University Medical Center at Princeton
Princeton, New Jersey, 08540
Roger Williams Medical Center
Providence, Rhode Island, 02908-4735
Utah Valley Regional Medical Center - Provo
Provo, Utah, 84604
All Saints Cancer Center at All Saints Healthcare
Racine, Wisconsin, 53405
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052
Bon Secours Cancer Care at St. Mary's Hospital
Richmond, Virginia, 23226
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, 23298-0058
Valley Hospital - Ridgewood
Ridgewood, New Jersey, 07450
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905-0001
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642
Regional Radiation Oncology Center at Rome
Rome, Georgia, 30165
CCOP - Beaumont
Royal Oak, Michigan, 48073-6769
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, 48073
Community Cancer Center at Rutland Regional Medical Center
Rutland, Vermont, 05701
Radiation Oncology Centers - Sacramento
Sacramento, California, 95815
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416
Peninsula Regional Medical Center
Salisbury, Maryland, 21801
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
LDS Hospital
Salt Lake City, Utah, 84143
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
Radiation Medical Group, Incorporated
San Diego, California, 92101-1492
Naval Medical Center - San Diego
San Diego, California, 92134-3202
UCSF Comprehensive Cancer Center
San Francisco, California, 94115
O'Connor Hospital
San Jose, California, 95128
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
Sarasota Radiation and Medical Oncology Center
Sarasota, Florida, 34233
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, 18501
Cancer Institute at Virginia Mason Medical Center
Seattle, Washington, 98111
North Shore Radiation Oncology
Setauket, New York, 11733
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
Deaconess Medical Center
Spokane, Washington, 99204
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
Saint Louis University Cancer Center
St Louis, Missouri, 63110-0250
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, 63110
Dixie Regional Medical Center
St. George, Utah, 84770
St. Joseph's Regional Cancer Center
Stockton, California, 95204
SUNY Upstate Medical University Hospital
Syracuse, New York, 13210
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, 33612-9497
CCOP - Scott and White Hospital
Temple, Texas, 76508
CCOP - Toledo Community Hospital
Toledo, Ohio, 43623-3456
Community Medical Center
Toms River, New Jersey, 08755
Torrance Memorial Medical Center
Torrance, California, 90505
General Robert Huyser Cancer Center at David Grant Medical Center
Travis Air Force Base, California, 94535
Fox Chase Cancer Center at St. Francis Medical Center
Trenton, New Jersey, 08629
William Beaumont Hospital - Troy Campus
Troy, Michigan, 48085
LaFortune Cancer Center at St. John Health System
Tulsa, Oklahoma, 74104
CCOP - Oklahoma
Tulsa, Oklahoma, 74136
DCH Cancer Treatment Center
Tuscaloosa, Alabama, 35401
South Jersey Healthcare Regional Cancer Center
Vineland, New Jersey, 08360
Associated Radiologists, P.A. at Warren Radiation Therapy Center
Warren Township, New Jersey, 07059
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, 53188
Schiffler Cancer Center at Wheeling Hospital
Wheeling, West Virginia, 26003
Wilkes-Barre General Hospital
Wilkes-Barre, Pennsylvania, 18764-0001
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1096
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
Yakima Valley Memorial Hospital
Yakima, Washington, 98902
Riverhill Radiation Oncology
Yonkers, New York, 10701
York Cancer Center at Wellspan Health
York, Pennsylvania, 17403
Canada20 sites
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Northeastern Ontario Regional Cancer Centre
Greater Sudbury, Ontario, P3E 5J1
Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Cancer Centre of Southeastern Ontario
Kingston, Ontario, K7L 5P9
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, N6A 4L6
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, E1C 8X3
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2L 4MI
McGill Cancer Centre at McGill University
Montreal, Quebec, H2W 1S6
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, K1H 8L6
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, G1R 2J6
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, S4T 7T1
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
CHUS-Hopital Fleurimont
Sherbrooke, Quebec, J1H 5N4
Newfoundland Cancer Treatment and Research Foundation
St. John's, Newfoundland and Labrador, A1B 3V6
Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: A Double-Blind Study Of Nutritional Intervention For The Treatment Of Cancer Cachexia Using Juven® Nutritional Supplement
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.
Read the 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.
- Conditions
- Cachexia, Lymphoma, Lymphoproliferative Disorder, Unspecified Adult Solid Tumor, Protocol Specific
- Being tested
- Juven, Non-Juven Supplement
- Keywords
- 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
- Medical subject headings
- Cachexia, Lymphoma, Lymphoproliferative Disorders, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Hodgkin Disease, Lymphoma, Large-Cell, Immunoblastic, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JuvenDietary supplement
Non-Juven SupplementDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Juven supplement | Experimental | Juven nutritional supplement given twice a day for 8 weeks Receives: Dietary Supplement: Juven |
| Non-Juven supplement | Active comparator | Non-Juven nutritional supplement given twice a day for 8 weeks Receives: Dietary Supplement: Non-Juven Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lean body mass
Measured: Study entry to 8 weeks
Secondary outcomes (4)
Fatigue
Measured: Study entry to 8 weeks
Quality of Life
Measured: Study entry to 8 weeks
Body weight
Measured: Study entry to 8 weeks
Correlation between change in lean body mass and body plethysmography, bioimpedance and skin-fold measurement
Measured: Study entry to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2003 (estimated)
- Study startDec 2002
- Primary completionMar 2005
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CachexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radiation Therapy Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lawrence B. Berk, MD, PhD, Study chair, CCOP - Columbus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00053053
- Sponsor's protocol ID
- RTOG-0122
- Other IDs
- CDR0000269100
- Status last verified
- Oct 2013
- First submitted
- 27 Jan 2003
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Berk L, James J, Schwartz A, Hug E, Mahadevan A, Samuels M, Kachnic L; RTOG. A randomized, double-blind, placebo-controlled trial of a beta-hydroxyl beta-methyl butyrate, glutamine, and arginine mixture for the treatment of cancer cachexia (RTOG 0122). Support Care Cancer. 2008 Oct;16(10):1179-88. doi: 10.1007/s00520-008-0403-7. Epub 2008 Feb 22.
PubMed 18293016