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

NCT00053053 | Completed Phase 3 DMC

• 2 other identifiers: RTOG-0122CDR0000269100
• Study Type: interventional
• Target: 472
• Locations: 2 countries
• Sites: 250

Brief 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 stage IV solid tumors.

Conditions

Cachexia; Lymphoma; Lymphoproliferative Disorder; Unspecified Adult Solid Tumor, Protocol Specific

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; 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; stage IV adult immunoblastic large cell lymphoma; stage IV adult lymphoblastic lymphoma; stage IV cutaneous T-cell non-Hodgkin lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage IV grade 3 follicular lymphoma; stage IV mantle cell lymphoma; intraocular lymphoma; AIDS-related peripheral/systemic lymphoma; recurrent adult Burkitt lymphoma; anaplastic large cell lymphoma; post-transplant lymphoproliferative disorder; recurrent marginal zone lymphoma; recurrent small lymphocytic lymphoma; stage III small lymphocytic lymphoma; stage III marginal zone lymphoma; stage IV small lymphocytic lymphoma; stage IV marginal zone lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma

Outcome Measures

Primary Outcomes (1)

• Lean body mass

  Study entry to 8 weeks

Secondary Outcomes (4)

• Fatigue

  Study entry to 8 weeks

• Quality of Life

  Study entry to 8 weeks

• Body weight

  Study entry to 8 weeks

• Correlation between change in lean body mass and body plethysmography, bioimpedance and skin-fold measurement

  Study entry to 8 weeks

Study Arms (2)

Juven supplement

EXPERIMENTAL

Juven nutritional supplement given twice a day for 8 weeks

Dietary Supplement: Juven

Non-Juven supplement

ACTIVE COMPARATOR

Non-Juven nutritional supplement given twice a day for 8 weeks

Dietary Supplement: Non-Juven Supplement

Interventions

Juven DIETARY_SUPPLEMENT

Juven supplement

Non-Juven Supplement DIETARY_SUPPLEMENT

Non-Juven supplement

Eligibility Criteria

• Age: 17 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (250)

Comprehensive Cancer Center at University of Alabama at Birmingham

Birmingham, Alabama, 35294-3300, United States

Location

Comprehensive Cancer Institute

Huntsville, Alabama, 35801, United States

Location

MBCCOP - Gulf Coast

Mobile, Alabama, 36607, United States

Location

Montgomery Cancer Center

Montgomery, Alabama, 36106-3657, United States

Location

DCH Cancer Treatment Center

Tuscaloosa, Alabama, 35401, United States

Location

Foundation for Cancer Research and Education

Phoenix, Arizona, 85013, United States

Location

Providence Saint Joseph Medical Center - Burbank

Burbank, California, 91505, United States

Location

Mount Diablo Regional Cancer Center

Concord, California, 94524-4110, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

California Cancer Center - Woodward Park Office

Fresno, California, 93720, United States

Location

Saint Agnes Cancer Center

Fresno, California, 93720, United States

Location

Sutter Health Western Division Cancer Research Group

Greenbrae, California, 94904, United States

Location

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Veterans Affairs Medical Center - Long Beach

Long Beach, California, 90822, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033-0804, United States

Location

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1714, United States

Location

CCOP - Bay Area Tumor Institute

Oakland, California, 94609-3305, United States

Location

Huntington Cancer Center at Huntington Hospital

Pasadena, California, 91105, United States

Location

Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center

Pomona, California, 91767, United States

Location

Radiation Oncology Centers - Sacramento

Sacramento, California, 95815, United States

Location

Radiation Medical Group, Incorporated

San Diego, California, 92101-1492, United States

Location

Naval Medical Center - San Diego

San Diego, California, 92134-3202, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

O'Connor Hospital

San Jose, California, 95128, United States

Location

CCOP - Santa Rosa Memorial Hospital

Santa Rosa, California, 95403, United States

Location

St. Joseph's Regional Cancer Center

Stockton, California, 95204, United States

Location

Torrance Memorial Medical Center

Torrance, California, 90505, United States

Location

General Robert Huyser Cancer Center at David Grant Medical Center

Travis Air Force Base, California, 94535, United States

Location

Memorial Hospital Cancer Center

Colorado Springs, Colorado, 80909, United States

Location

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Denver, Colorado, 80010, United States

Location

St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

Grand Junction, Colorado, 81502-1628, United States

Location

Hospital of Saint Raphael

New Haven, Connecticut, 06511, United States

Location

Yale Comprehensive Cancer Center

New Haven, Connecticut, 06520-8040, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

Location

21st Century Oncology - Fort Myers

Fort Myers, Florida, 33901-8082, United States

Location

University of Florida Shands Cancer Center

Gainesville, Florida, 32610-0385, United States

Location

Florida Radiation Oncology Group

Jacksonville, Florida, 32207, United States

Location

Holmes Regional Medical Center

Melbourne, Florida, 32901-3276, United States

Location

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Baptist-South Miami Regional Cancer Program

Miami, Florida, 33176-2197, United States

Location

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Bay Medical Center

Panama City, Florida, 32401, United States

Location

Gulf Coast Cancer Treatment Center

Panama City, Florida, 32405-4587, United States

Location

Sarasota Radiation and Medical Oncology Center

Sarasota, Florida, 34233, United States

Location

Tallahassee Memorial Hospital

Tallahassee, Florida, 32308, United States

Location

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Tampa, Florida, 33612-9497, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

CCOP - Atlanta Regional

Atlanta, Georgia, 30342-1701, United States

Location

John B. Amos Community Cancer Center

Columbus, Georgia, 31904, United States

Location

Regional Radiation Oncology Center at Rome

Rome, Georgia, 30165, United States

Location

MBCCOP - Hawaii

Honolulu, Hawaii, 96813, United States

Location

Northwest Community Hospital

Arlington Heights, Illinois, 60005, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62526, United States

Location

Ingalls Cancer Care Center at Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Lutheran General Cancer Care Center

Park Ridge, Illinois, 60068, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

Location

St. John's Cancer Center at St. John's Medical Center

Anderson, Indiana, 46016, United States

Location

Bloomington Hospital

Bloomington, Indiana, 47402, United States

Location

Veterans Affairs Medical Center - Indianapolis (Roudebush)

Indianapolis, Indiana, 46202, United States

Location

Methodist Cancer Center at Methodist Hospital

Indianapolis, Indiana, 46206-1367, United States

Location

Oncology Institute of Greater Lafayette

Lafayette, Indiana, 47904, United States

Location

Cancer Center at Ball Memorial Hospital

Muncie, Indiana, 47303-3499, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Wendt Regional Cancer Center at Finley Hospital

Dubuque, Iowa, 52001, United States

Location

Esther Marie Hatton Cancer Care Center at St. Elizabeth Medical Center

Edgewood, Kentucky, 41017, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

Cancer Center at Lexington Clinic

Lexington, Kentucky, 40504, United States

Location

Markey Cancer Center at University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536-0293, United States

Location

James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, 40202, United States

Location

Louisville Radiation Oncology Center at Caritas Regional Cancer Center

Louisville, Kentucky, 40215, United States

Location

Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County

Madisonville, Kentucky, 42431, United States

Location

Mary Bird Perkins Cancer Center - Baton Rouge

Baton Rouge, Louisiana, 70809-3482, United States

Location

Tulane Cancer Center at Tulane University Hospital and Clinic

New Orleans, Louisiana, 70112-2699, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

CCOP - Ochsner

New Orleans, Louisiana, 70121, United States

Location

Maine Medical Center - Bramhall Campus

Portland, Maine, 04102, United States

Location

DeCesaris Cancer Institute at Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States

Location

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Cancer Center at Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

Harbor Hospital Center

Baltimore, Maryland, 21215-1290, United States

Location

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

Baltimore, Maryland, 21215, United States

Location

St. Agnes Cancer Center

Baltimore, Maryland, 21229, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Peninsula Regional Medical Center

Salisbury, Maryland, 21801, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02114, United States

Location

Cancer Research Center at Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Cape Cod Hospital

Hyannis, Massachusetts, 02601, United States

Location

Veterans Affairs Medical Center - Boston (Jamaica Plain)

Jamaica Plain, Massachusetts, 02130, United States

Location

NSMC Cancer Center - Peabody

Peabody, Massachusetts, 01960, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0010, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Josephine Ford Cancer Center at Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Great Lakes Cancer Institute at McLaren Regional Medical Center

Flint, Michigan, 48532-3685, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

Upper Michigan Cancer Center at Marquette General Hospital

Marquette, Michigan, 49855, United States

Location

MidMichigan Medical Center - Midland

Midland, Michigan, 48670, United States

Location

CCOP - Beaumont

Royal Oak, Michigan, 48073-6769, United States

Location

William Beaumont Hospital - Royal Oak Campus

Royal Oak, Michigan, 48073, United States

Location

William Beaumont Hospital - Troy Campus

Troy, Michigan, 48085, United States

Location

Fairview University Medical Center - University Campus

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905-0001, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65807, United States

Location

Saint Louis University Cancer Center

St Louis, Missouri, 63110-0250, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha

Omaha, Nebraska, 68114-4199, United States

Location

UNMC Eppley Cancer Center at the University of Nebraska Medical Center

Omaha, Nebraska, 68198-7521, United States

Location

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Elliot Regional Cancer Center

Manchester, New Hampshire, 03103, United States

Location

Veterans Affairs Medical Center - East Orange

East Orange, New Jersey, 07018, United States

Location

John F. Kennedy Medical Center

Edison, New Jersey, 08818, United States

Location

Monmouth Medical Center

Long Branch, New Jersey, 07740-6395, United States

Location

Fox Chase Virtua Health Cancer Program - Marlton

Mount Holly, New Jersey, 08060, United States

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

Atlantic City Medical Center - Mainland Division

Pomona, New Jersey, 08240, United States

Location

University Medical Center at Princeton

Princeton, New Jersey, 08540, United States

Location

Valley Hospital - Ridgewood

Ridgewood, New Jersey, 07450, United States

Location

Community Medical Center

Toms River, New Jersey, 08755, United States

Location

Fox Chase Cancer Center at St. Francis Medical Center

Trenton, New Jersey, 08629, United States

Location

South Jersey Healthcare Regional Cancer Center

Vineland, New Jersey, 08360, United States

Location

Associated Radiologists, P.A. at Warren Radiation Therapy Center

Warren Township, New Jersey, 07059, United States

Location

Radiation Oncology Associates, PA

Albuquerque, New Mexico, 87109, United States

Location

Lourdes Regional Cancer Center

Binghamton, New York, 13905, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

New York Methodist Hospital

Brooklyn, New York, 11215-3609, United States

Location

Finger Lakes Radiation Oncology Center at Clifton Springs Hospital and clinic

Clifton Springs, New York, 14432, United States

Location

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

East Syracuse, New York, 13057, United States

Location

CCOP - North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Beth Israel Medical Center - Philipps Ambulatory Care Center

New York, New York, 10003, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center

Plattsburgh, New York, 12901-1490, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

North Shore Radiation Oncology

Setauket, New York, 11733, United States

Location

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210, United States

Location

Riverhill Radiation Oncology

Yonkers, New York, 10701, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Batte Cancer Center at Northeast Medical Center

Concord, North Carolina, 28025, United States

Location

CCOP - Southeast Cancer Control Consortium

Goldsboro, North Carolina, 27534-9479, United States

Location

Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital

Greenville, North Carolina, 27835-6028, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1096, United States

Location

Trinity Cancer Care Center

Minot, North Dakota, 58701, United States

Location

McDowell Cancer Center at Akron General Medical Center

Akron, Ohio, 44302, United States

Location

Akron City Hospital at Summa Health System

Akron, Ohio, 44304, United States

Location

Cancer Center at Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45219, United States

Location

Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University

Cleveland, Ohio, 44106-5047, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

CCOP - Columbus

Columbus, Ohio, 43206, United States

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

CCOP - Dayton

Dayton, Ohio, 45429, United States

Location

Parma Community General Hospital

Parma, Ohio, 44129, United States

Location

CCOP - Toledo Community Hospital

Toledo, Ohio, 43623-3456, United States

Location

Frank C. Love Cancer Institute at St. Anthony Hospital

Oklahoma City, Oklahoma, 73102, United States

Location

Oklahoma University Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

LaFortune Cancer Center at St. John Health System

Tulsa, Oklahoma, 74104, United States

Location

CCOP - Oklahoma

Tulsa, Oklahoma, 74136, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital

Allentown, Pennsylvania, 18105-1556, United States

Location

St. Luke's Hospital Cancer Center

Bethlehem, Pennsylvania, 18015, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Mercy Fitzgerald Hospital

Darby, Pennsylvania, 19023, United States

Location

Delaware County Regional Cancer Center at Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, 19026, United States

Location

Dale and Frances Hughes Cancer Center at Pocono Medical Center

East Stroudsburg, Pennsylvania, 18301, United States

Location

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Albert Einstein Cancer Center

Philadelphia, Pennsylvania, 19141-3098, United States

Location

Allegheny Cancer Center at Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212-4772, United States

Location

Mercy Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

Location

Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

Hillman Cancer Center at University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

Reading Hospital and Medical Center

Reading, Pennsylvania, 19612-6052, United States

Location

Mercy Hospital Cancer Center - Scranton

Scranton, Pennsylvania, 18501, United States

Location

Wilkes-Barre General Hospital

Wilkes-Barre, Pennsylvania, 18764-0001, United States

Location

CCOP - MainLine Health

Wynnewood, Pennsylvania, 19096, United States

Location

York Cancer Center at Wellspan Health

York, Pennsylvania, 17403, United States

Location

Roger Williams Medical Center

Providence, Rhode Island, 02908-4735, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57709, United States

Location

West Tennessee Cancer Center at Jackson-Madison County General Hospital

Jackson, Tennessee, 38301, United States

Location

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

Nashville, Tennessee, 37232-5671, United States

Location

Harrington Cancer Center

Amarillo, Texas, 79106, United States

Location

Arlington Cancer Center - Arlington

Arlington, Texas, 76012, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0209, United States

Location

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Wilford Hall Medical Center

Lackland Air Force Base, Texas, 78236-5300, United States

Location

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, 79410, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

Utah Valley Regional Medical Center - Provo

Provo, Utah, 84604, United States

Location

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Dixie Regional Medical Center

St. George, Utah, 84770, United States

Location

Vermont Cancer Center at University of Vermont

Burlington, Vermont, 05405-0075, United States

Location

Community Cancer Center at Rutland Regional Medical Center

Rutland, Vermont, 05701, United States

Location

Cancer Center at the University of Virginia

Charlottesville, Virginia, 22908, United States

Location

RMH Regional Cancer Center

Harrisonburg, Virginia, 22801, United States

Location

Naval Medical Center - Portsmouth

Portsmouth, Virginia, 23708-1912, United States

Location

Bon Secours Cancer Care at St. Mary's Hospital

Richmond, Virginia, 23226, United States

Location

Massey Cancer Center at Virginia Commonwealth University

Richmond, Virginia, 23298-0058, United States

Location

Cancer Institute at Virginia Mason Medical Center

Seattle, Washington, 98111, United States

Location

Deaconess Medical Center

Spokane, Washington, 99204, United States

Location

Yakima Valley Memorial Hospital

Yakima, Washington, 98902, United States

Location

Schiffler Cancer Center at Wheeling Hospital

Wheeling, West Virginia, 26003, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54301, United States

Location

St. Vincent Hospital

Green Bay, Wisconsin, 54307-3508, United States

Location

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, 54449, United States

Location

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, 54449, United States

Location

Community Memorial Hospital

Menomonee Falls, Wisconsin, 53051, United States

Location

Columbia St. Mary's - Columbia Campus

Milwaukee, Wisconsin, 53211, United States

Location

Vince Lombardi Cancer Clinic at St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Veterans Affairs Medical Center - Milwaukee (Zablocki)

Milwaukee, Wisconsin, 53295, United States

Location

All Saints Cancer Center at All Saints Healthcare

Racine, Wisconsin, 53405, United States

Location

Waukesha Memorial Hospital Regional Cancer Center

Waukesha, Wisconsin, 53188, United States

Location

Tom Baker Cancer Centre - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Doctor Leon Richard Oncology Centre

Moncton, New Brunswick, E1C 8X3, Canada

Location

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

Location

Newfoundland Cancer Treatment and Research Foundation

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Northeastern Ontario Regional Cancer Centre

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Centre of Southeastern Ontario

Kingston, Ontario, K7L 5P9, Canada

Location

London Regional Cancer Program at London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

Ottawa Hospital Regional Cancer Centre - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Regional Cancer Care at Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, P7B 6V4, Canada

Location

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2L 4MI, Canada

Location

McGill Cancer Centre at McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

Centre Hospitalier Universitaire de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

CHUS-Hopital Fleurimont

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Allan Blair Cancer Centre at Pasqua Hospital

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Related Publications (1)

• 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.

  PMID: 18293016 RESULT

MeSH Terms

Conditions

Cachexia; Lymphoma; Lymphoproliferative Disorders; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin; Hodgkin Disease; Lymphoma, Large-Cell, Immunoblastic; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, T-Cell, Cutaneous; Lymphoma, Follicular; Lymphoma, Mantle-Cell; Burkitt Lymphoma; Intraocular Lymphoma; Lymphoma, Large-Cell, Anaplastic; Lymphoma, B-Cell, Marginal Zone; Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Neoplasms by Histologic Type; Neoplasms; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Lymphoma, T-Cell; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Eye Neoplasms; Neoplasms by Site; Leukemia, B-Cell; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Lawrence B. Berk, MD, PhD

  CCOP - Columbus

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2003
• First Posted: January 28, 2003
• Study Start: December 1, 2002
• Primary Completion: March 1, 2005
• Study Completion: February 1, 2009
• Last Updated: December 8, 2016

Record last verified: 2013-10

Locations

CA (20); US (230)