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

Lymphoma Clinical Trial

Official title:

A Double-Blind Study Of Nutritional Intervention For The Treatment Of Cancer Cachexia Using Juven® Nutritional Supplement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00053053
• Other study ID #: RTOG-0122
• Secondary ID: CDR0000269100
• Status: Completed
• Phase: Phase 3
• First received: January 27, 2003
• Last updated: December 6, 2016
• Start date: December 2002
• Est. completion date: February 2009

Study information

• Verified date: October 2013
• Source: Radiation Therapy Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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 stage IV solid tumors.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 472
• Est. completion date: February 2009
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 120 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cachexia
• Lymphoma
• Lymphoproliferative Disorder
• Lymphoproliferative Disorders
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Dietary Supplement:
• Juven

• Non-Juven Supplement

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Radiation Therapy Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & 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). S — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lean body mass		Study entry to 8 weeks	No
Secondary	Fatigue		Study entry to 8 weeks	No
Secondary	Quality of Life		Study entry to 8 weeks	No
Secondary	Body weight		Study entry to 8 weeks	No
Secondary	Correlation between change in lean body mass and body plethysmography, bioimpedance and skin-fold measurement		Study entry to 8 weeks	No