Clinical trial NCT00053053: Comparison of Nutritional Supplements in Preventing Weight Loss in Patients With Cancer
Official title: A Double-Blind Study Of Nutritional Intervention For The Treatment Of Cancer Cachexia Using Juven® Nutritional Supplement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Radiation Therapy Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-28
Enrollment: 472
Sex: ALL
Minimum age (years): 17
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 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

Primary outcomes:
measure: Lean body mass
timeFrame: Study entry to 8 weeks
Secondary outcomes:
measure: Fatigue
timeFrame: Study entry to 8 weeks
measure: Quality of Life
timeFrame: Study entry to 8 weeks
measure: Body weight
timeFrame: Study entry to 8 weeks
measure: Correlation between change in lean body mass and body plethysmography, bioimpedance and skin-fold measurement
timeFrame: Study entry to 8 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Comprehensive Cancer Center at University of Alabama at Birmingham
state: Alabama
city: Huntsville
country: United States
facility: Comprehensive Cancer Institute
state: Alabama
city: Mobile
country: United States
facility: MBCCOP - Gulf Coast
state: Alabama
city: Montgomery
country: United States
facility: Montgomery Cancer Center
state: Alabama
city: Tuscaloosa
country: United States
facility: DCH Cancer Treatment Center
state: Alabama
city: Phoenix
country: United States
facility: Foundation for Cancer Research and Education
state: Arizona
city: Burbank
country: United States
facility: Providence Saint Joseph Medical Center - Burbank
state: California
city: Concord
country: United States
facility: Mount Diablo Regional Cancer Center
state: California
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
city: Fresno
country: United States
facility: California Cancer Center - Woodward Park Office
state: California
city: Fresno
country: United States
facility: Saint Agnes Cancer Center
state: California
city: Greenbrae
country: United States
facility: Sutter Health Western Division Cancer Research Group
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Cancer Institute at Loma Linda University Medical Center
state: California
city: Long Beach
country: United States
facility: Veterans Affairs Medical Center - Long Beach
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center and Hospital
state: California
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center at UCLA
state: California
city: Oakland
country: United States
facility: CCOP - Bay Area Tumor Institute
state: California
city: Pasadena
country: United States
facility: Huntington Cancer Center at Huntington Hospital
state: California
city: Pomona
country: United States
facility: Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
state: California
city: Sacramento
country: United States
facility: Radiation Oncology Centers - Sacramento
state: California
city: San Diego
country: United States
facility: Radiation Medical Group, Incorporated
state: California
city: San Diego
country: United States
facility: Naval Medical Center - San Diego
state: California
city: San Francisco
country: United States
facility: UCSF Comprehensive Cancer Center
state: California
city: San Jose
country: United States
facility: O'Connor Hospital
state: California
city: Santa Rosa
country: United States
facility: CCOP - Santa Rosa Memorial Hospital
state: California
city: Stockton
country: United States
facility: St. Joseph's Regional Cancer Center
state: California
city: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: Travis Air Force Base
country: United States
facility: General Robert Huyser Cancer Center at David Grant Medical Center
state: California
city: Colorado Springs
country: United States
facility: Memorial Hospital Cancer Center
state: Colorado
city: Denver
country: United States
facility: University of Colorado Cancer Center at University of Colorado Health Sciences Center
state: Colorado
city: Grand Junction
country: United States
facility: St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
state: Colorado
city: New Haven
country: United States
facility: Hospital of Saint Raphael
state: Connecticut
city: New Haven
country: United States
facility: Yale Comprehensive Cancer Center
state: Connecticut
city: Newark
country: United States
facility: CCOP - Christiana Care Health Services
state: Delaware
city: Washington
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
city: Fort Myers
country: United States
facility: 21st Century Oncology - Fort Myers
state: Florida
city: Gainesville
country: United States
facility: University of Florida Shands Cancer Center
state: Florida
city: Jacksonville
country: United States
facility: Florida Radiation Oncology Group
state: Florida
city: Melbourne
country: United States
facility: Holmes Regional Medical Center
state: Florida
city: Miami Beach
country: United States
facility: CCOP - Mount Sinai Medical Center
state: Florida
city: Miami
country: United States
facility: University of Miami Sylvester Comprehensive Cancer Center
state: Florida
city: Miami
country: United States
facility: Baptist-South Miami Regional Cancer Program
state: Florida
city: Panama City
country: United States
facility: Bay Medical Center
state: Florida
city: Panama City
country: United States
facility: Gulf Coast Cancer Treatment Center
state: Florida
city: Sarasota
country: United States
facility: Sarasota Radiation and Medical Oncology Center
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University
state: Georgia
city: Atlanta
country: United States
facility: CCOP - Atlanta Regional
state: Georgia
city: Columbus
country: United States
facility: John B. Amos Community Cancer Center
state: Georgia
city: Rome
country: United States
facility: Regional Radiation Oncology Center at Rome
state: Georgia
city: Honolulu
country: United States
facility: MBCCOP - Hawaii
state: Hawaii
city: Arlington Heights
country: United States
facility: Northwest Community Hospital
state: Illinois
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center at Northwestern University
state: Illinois
city: Decatur
country: United States
facility: CCOP - Central Illinois
state: Illinois
city: Harvey
country: United States
facility: Ingalls Cancer Care Center at Ingalls Memorial Hospital
state: Illinois
city: Maywood
country: United States
facility: Cardinal Bernardin Cancer Center at Loyola University Medical Center
state: Illinois
city: Park Ridge
country: United States
facility: Lutheran General Cancer Care Center
state: Illinois
city: Peoria
country: United States
facility: Methodist Medical Center of Illinois
state: Illinois
city: Anderson
country: United States
facility: St. John's Cancer Center at St. John's Medical Center
state: Indiana
city: Bloomington
country: United States
facility: Bloomington Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Veterans Affairs Medical Center - Indianapolis (Roudebush)
state: Indiana
city: Indianapolis
country: United States
facility: Methodist Cancer Center at Methodist Hospital
state: Indiana
city: Lafayette
country: United States
facility: Oncology Institute of Greater Lafayette
state: Indiana
city: Muncie
country: United States
facility: Cancer Center at Ball Memorial Hospital
state: Indiana
city: South Bend
country: United States
facility: CCOP - Northern Indiana CR Consortium
state: Indiana
city: Dubuque
country: United States
facility: Wendt Regional Cancer Center at Finley Hospital
state: Iowa
city: Edgewood
country: United States
facility: Esther Marie Hatton Cancer Care Center at St. Elizabeth Medical Center
state: Kentucky
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Lexington
country: United States
facility: Cancer Center at Lexington Clinic
state: Kentucky
city: Lexington
country: United States
facility: Markey Cancer Center at University of Kentucky Chandler Medical Center
state: Kentucky
city: Louisville
country: United States
facility: James Graham Brown Cancer Center at University of Louisville
state: Kentucky
city: Louisville
country: United States
facility: Louisville Radiation Oncology Center at Caritas Regional Cancer Center
state: Kentucky
city: Madisonville
country: United States
facility: Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
state: Kentucky
city: Baton Rouge
country: United States
facility: Mary Bird Perkins Cancer Center - Baton Rouge
state: Louisiana
city: New Orleans
country: United States
facility: Tulane Cancer Center at Tulane University Hospital and Clinic
state: Louisiana
city: New Orleans
country: United States
facility: MBCCOP - LSU Health Sciences Center
state: Louisiana
city: New Orleans
country: United States
facility: CCOP - Ochsner
state: Louisiana
city: Portland
country: United States
facility: Maine Medical Center - Bramhall Campus
state: Maine
city: Annapolis
country: United States
facility: DeCesaris Cancer Institute at Anne Arundel Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Greenebaum Cancer Center at University of Maryland Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Cancer Center at Greater Baltimore Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Harbor Hospital Center
state: Maryland
city: Baltimore
country: United States
facility: Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
state: Maryland
city: Baltimore
country: United States
facility: St. Agnes Cancer Center
state: Maryland
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Salisbury
country: United States
facility: Peninsula Regional Medical Center
state: Maryland
city: Boston
country: United States
facility: Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Cancer Research Center at Boston Medical Center
state: Massachusetts
city: Hyannis
country: United States
facility: Cape Cod Hospital
state: Massachusetts
city: Jamaica Plain
country: United States
facility: Veterans Affairs Medical Center - Boston (Jamaica Plain)
state: Massachusetts
city: Peabody
country: United States
facility: NSMC Cancer Center - Peabody
state: Massachusetts
city: Ann Arbor
country: United States
facility: CCOP - Michigan Cancer Research Consortium
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Josephine Ford Cancer Center at Henry Ford Health System
state: Michigan
city: Flint
country: United States
facility: Great Lakes Cancer Institute at McLaren Regional Medical Center
state: Michigan
city: Kalamazoo
country: United States
facility: CCOP - Kalamazoo
state: Michigan
city: Marquette
country: United States
facility: Upper Michigan Cancer Center at Marquette General Hospital
state: Michigan
city: Midland
country: United States
facility: MidMichigan Medical Center - Midland
state: Michigan
city: Royal Oak
country: United States
facility: CCOP - Beaumont
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital - Royal Oak Campus
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital - Troy Campus
state: Michigan
city: Minneapolis
country: United States
facility: Fairview University Medical Center - University Campus
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Saint Louis Park
country: United States
facility: CCOP - Metro-Minnesota
state: Minnesota
city: Columbia
country: United States
facility: Ellis Fischel Cancer Center at University of Missouri - Columbia
state: Missouri
city: Kansas City
country: United States
facility: CCOP - Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University Cancer Center
state: Missouri
city: Springfield
country: United States
facility: CCOP - Cancer Research for the Ozarks
state: Missouri
city: St. Louis
country: United States
facility: Siteman Cancer Center at Barnes-Jewish Hospital
state: Missouri
city: Billings
country: United States
facility: CCOP - Montana Cancer Consortium
state: Montana
city: Omaha
country: United States
facility: CCOP - Missouri Valley Cancer Consortium
state: Nebraska
city: Omaha
country: United States
facility: Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
state: Nebraska
city: Omaha
country: United States
facility: UNMC Eppley Cancer Center at the University of Nebraska Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: CCOP - Southern Nevada Cancer Research Foundation
state: Nevada
city: Lebanon
country: United States
facility: Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Manchester
country: United States
facility: Elliot Regional Cancer Center
state: New Hampshire
city: East Orange
country: United States
facility: Veterans Affairs Medical Center - East Orange
state: New Jersey
city: Edison
country: United States
facility: John F. Kennedy Medical Center
state: New Jersey
city: Long Branch
country: United States
facility: Monmouth Medical Center
state: New Jersey
city: Mount Holly
country: United States
facility: Fox Chase Virtua Health Cancer Program - Marlton
state: New Jersey
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
state: New Jersey
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: Pomona
country: United States
facility: Atlantic City Medical Center - Mainland Division
state: New Jersey
city: Princeton
country: United States
facility: University Medical Center at Princeton
state: New Jersey
city: Ridgewood
country: United States
facility: Valley Hospital - Ridgewood
state: New Jersey
city: Toms River
country: United States
facility: Community Medical Center
state: New Jersey
city: Trenton
country: United States
facility: Fox Chase Cancer Center at St. Francis Medical Center
state: New Jersey
city: Vineland
country: United States
facility: South Jersey Healthcare Regional Cancer Center
state: New Jersey
city: Warren
country: United States
facility: Associated Radiologists, P.A. at Warren Radiation Therapy Center
state: New Jersey
city: Albuquerque
country: United States
facility: Radiation Oncology Associates, PA
state: New Mexico
city: Binghamton
country: United States
facility: Lourdes Regional Cancer Center
state: New York
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: Clifton Springs
country: United States
facility: Finger Lakes Radiation Oncology Center at Clifton Springs Hospital and clinic
state: New York
city: East Syracuse
country: United States
facility: CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
state: New York
city: Manhasset
country: United States
facility: CCOP - North Shore University Hospital
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center - Philipps Ambulatory Care Center
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Herbert Irving Comprehensive Cancer Center at Columbia University
state: New York
city: Plattsburgh
country: United States
facility: Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center
state: New York
city: Rochester
country: United States
facility: James P. Wilmot Cancer Center at University of Rochester Medical Center
state: New York
city: Setauket
country: United States
facility: North Shore Radiation Oncology
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University Hospital
state: New York
city: Yonkers
country: United States
facility: Riverhill Radiation Oncology
state: New York
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
state: North Carolina
city: Concord
country: United States
facility: Batte Cancer Center at Northeast Medical Center
state: North Carolina
city: Goldsboro
country: United States
facility: CCOP - Southeast Cancer Control Consortium
state: North Carolina
city: Greenville
country: United States
facility: Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center at Wake Forest University
state: North Carolina
city: Minot
country: United States
facility: Trinity Cancer Care Center
state: North Dakota
city: Akron
country: United States
facility: McDowell Cancer Center at Akron General Medical Center
state: Ohio
city: Akron
country: United States
facility: Akron City Hospital at Summa Health System
state: Ohio
city: Cincinnati
country: United States
facility: Cancer Center at Christ Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Charles M. Barrett Cancer Center at University Hospital
state: Ohio
city: Cleveland
country: United States
facility: Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
city: Columbus
country: United States
facility: CCOP - Columbus
state: Ohio
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
state: Ohio
city: Dayton
country: United States
facility: CCOP - Dayton
state: Ohio
city: Parma
country: United States
facility: Parma Community General Hospital
state: Ohio
city: Toledo
country: United States
facility: CCOP - Toledo Community Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Frank C. Love Cancer Institute at St. Anthony Hospital
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma University Medical Center
state: Oklahoma
city: Tulsa
country: United States
facility: LaFortune Cancer Center at St. John Health System
state: Oklahoma
city: Tulsa
country: United States
facility: CCOP - Oklahoma
state: Oklahoma
city: Portland
country: United States
facility: CCOP - Columbia River Oncology Program
state: Oregon
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Allentown
country: United States
facility: John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
state: Pennsylvania
city: Bethlehem
country: United States
facility: St. Luke's Hospital Cancer Center
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Darby
country: United States
facility: Mercy Fitzgerald Hospital
state: Pennsylvania
city: Drexel Hill
country: United States
facility: Delaware County Regional Cancer Center at Delaware County Memorial Hospital
state: Pennsylvania
city: East Stroudsburg
country: United States
facility: Dale and Frances Hughes Cancer Center at Pocono Medical Center
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Cancer Institute at Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Cancer Center at Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Mercy Hospital of Pittsburgh
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Hillman Cancer Center at University of Pittsburgh Cancer Institute
state: Pennsylvania
city: Reading
country: United States
facility: Reading Hospital and Medical Center
state: Pennsylvania
city: Scranton
country: United States
facility: Mercy Hospital Cancer Center - Scranton
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Wilkes-Barre General Hospital
state: Pennsylvania
city: Wynnewood
country: United States
facility: CCOP - MainLine Health
state: Pennsylvania
city: York
country: United States
facility: York Cancer Center at Wellspan Health
state: Pennsylvania
city: Providence
country: United States
facility: Roger Williams Medical Center
state: Rhode Island
city: Greenville
country: United States
facility: CCOP - Greenville
state: South Carolina
city: Spartanburg
country: United States
facility: CCOP - Upstate Carolina
state: South Carolina
city: Rapid City
country: United States
facility: Rapid City Regional Hospital
state: South Dakota
city: Jackson
country: United States
facility: West Tennessee Cancer Center at Jackson-Madison County General Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
state: Tennessee
city: Amarillo
country: United States
facility: Harrington Cancer Center
state: Texas
city: Arlington
country: United States
facility: Arlington Cancer Center - Arlington
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: M.D. Anderson Cancer Center at University of Texas
state: Texas
city: Lackland Air Force Base
country: United States
facility: Wilford Hall Medical Center
state: Texas
city: Lubbock
country: United States
facility: Joe Arrington Cancer Research and Treatment Center
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Temple
country: United States
facility: CCOP - Scott and White Hospital
state: Texas
city: Provo
country: United States
facility: Utah Valley Regional Medical Center - Provo
state: Utah
city: Saint George
country: United States
facility: Dixie Regional Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
city: Burlington
country: United States
facility: Vermont Cancer Center at University of Vermont
state: Vermont
city: Rutland
country: United States
facility: Community Cancer Center at Rutland Regional Medical Center
state: Vermont
city: Charlottesville
country: United States
facility: Cancer Center at the University of Virginia
state: Virginia
city: Harrisonburg
country: United States
facility: RMH Regional Cancer Center
state: Virginia
city: Portsmouth
country: United States
facility: Naval Medical Center - Portsmouth
state: Virginia
city: Richmond
country: United States
facility: Bon Secours Cancer Care at St. Mary's Hospital
state: Virginia
city: Richmond
country: United States
facility: Massey Cancer Center at Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: Cancer Institute at Virginia Mason Medical Center
state: Washington
city: Spokane
country: United States
facility: Deaconess Medical Center
state: Washington
city: Yakima
country: United States
facility: Yakima Valley Memorial Hospital
state: Washington
city: Wheeling
country: United States
facility: Schiffler Cancer Center at Wheeling Hospital
state: West Virginia
city: Green Bay
country: United States
facility: CCOP - St. Vincent Hospital Cancer Center, Green Bay
state: Wisconsin
city: Green Bay
country: United States
facility: St. Vincent Hospital
state: Wisconsin
city: La Crosse
country: United States
facility: Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Comprehensive Cancer Center
state: Wisconsin
city: Marshfield
country: United States
facility: CCOP - Marshfield Clinic Research Foundation
state: Wisconsin
city: Marshfield
country: United States
facility: Marshfield Clinic - Marshfield Center
state: Wisconsin
city: Menomonee Falls
country: United States
facility: Community Memorial Hospital
state: Wisconsin
city: Milwaukee
country: United States
facility: Columbia St. Mary's - Columbia Campus
state: Wisconsin
city: Milwaukee
country: United States
facility: Vince Lombardi Cancer Clinic at St. Luke's Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Veterans Affairs Medical Center - Milwaukee (Zablocki)
state: Wisconsin
city: Racine
country: United States
facility: All Saints Cancer Center at All Saints Healthcare
state: Wisconsin
city: Waukesha
country: United States
facility: Waukesha Memorial Hospital Regional Cancer Center
state: Wisconsin
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre - Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Moncton
country: Canada
facility: Doctor Leon Richard Oncology Centre
state: New Brunswick
city: Saint John
country: Canada
facility: Saint John Regional Hospital
state: New Brunswick
city: St. Johns
country: Canada
facility: Newfoundland Cancer Treatment and Research Foundation
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Margaret and Charles Juravinski Cancer Centre
state: Ontario
city: Kingston
country: Canada
facility: Cancer Centre of Southeastern Ontario
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Program at London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Regional Cancer Centre - General Campus
state: Ontario
city: Sudbury
country: Canada
facility: Northeastern Ontario Regional Cancer Centre
state: Ontario
city: Thunder Bay
country: Canada
facility: Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto Sunnybrook Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal
state: Quebec
city: Montreal
country: Canada
facility: McGill Cancer Centre at McGill University
state: Quebec
city: Quebec City
country: Canada
facility: Centre Hospitalier Universitaire de Quebec
state: Quebec
city: Sherbrooke
country: Canada
facility: CHUS-Hopital Fleurimont
state: Quebec
city: Regina
country: Canada
facility: Allan Blair Cancer Centre at Pasqua Hospital
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre
state: Saskatchewan
Study officials:
affiliation: CCOP - Columbus
name: Lawrence B. Berk, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.