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

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.

Study Overview

• Status: Completed
• Conditions: Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific; Cachexia; Lymphoproliferative Disorder
• Intervention / Treatment: Dietary supplement: Juven; Dietary supplement: Non-Juven Supplement

Detailed Description

OBJECTIVES:

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

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

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

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

• Study Type: Interventional
• Enrollment (Actual): 472
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 118 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Juven supplement; Juven nutritional supplement given twice a day for 8 weeks	Dietary supplement: Juven
Active Comparator: Non-Juven supplement; Non-Juven nutritional supplement given twice a day for 8 weeks	Dietary supplement: Non-Juven Supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Lean body mass	Study entry to 8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Radiation Therapy Oncology Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Lawrence B. Berk, MD, PhD, CCOP - Columbus

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2002
• Primary Completion (Actual): March 1, 2005
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: January 27, 2003
• First Submitted That Met QC Criteria: January 27, 2003
• First Posted (Estimate): January 28, 2003

Study Record Updates

• Last Update Posted (Estimate): December 8, 2016
• Last Update Submitted That Met QC Criteria: December 6, 2016
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: unspecified adult solid tumor, protocol specific; stage III adult diffuse large cell lymphoma; stage III adult immunoblastic large cell lymphoma; stage III adult Burkitt lymphoma; stage IV grade 3 follicular lymphoma; stage IV adult diffuse large cell lymphoma; stage IV adult immunoblastic large cell lymphoma; stage IV adult Burkitt lymphoma; recurrent grade 3 follicular lymphoma; recurrent adult diffuse large cell lymphoma; recurrent adult immunoblastic large cell lymphoma; recurrent adult Burkitt lymphoma; AIDS-related peripheral/systemic lymphoma; recurrent adult Hodgkin lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult diffuse mixed cell lymphoma; cachexia; stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage III grade 3 follicular lymphoma; stage III adult diffuse small cleaved cell lymphoma; stage III adult diffuse mixed cell lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage IV adult diffuse small cleaved cell lymphoma; stage IV adult diffuse mixed cell lymphoma; stage III mantle cell lymphoma; stage IV mantle cell lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; 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; recurrent adult lymphoblastic lymphoma; recurrent mantle cell lymphoma; stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma; stage III cutaneous T-cell non-Hodgkin lymphoma; stage IV cutaneous T-cell non-Hodgkin lymphoma; recurrent cutaneous T-cell non-Hodgkin lymphoma; stage III adult lymphoblastic lymphoma; stage IV adult lymphoblastic lymphoma; intraocular lymphoma; anaplastic large cell lymphoma; post-transplant lymphoproliferative disorder
• Additional Relevant MeSH Terms: Metabolic Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphatic Diseases; Immunoproliferative Disorders; Nutrition Disorders; Body Weight; Body Weight Changes; Emaciation; Weight Loss; Lymphoma; Wasting Syndrome; Cachexia; Lymphoproliferative Disorders
• Other Study ID Numbers: RTOG-0122; CDR0000269100