A Double-Blind Study Of Nutritional Intervention For The Treatment Of Cancer Cachexia Using Juven® Nutritional Supplement
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.
Interventional
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Lawrence B. Berk, MD, PhD
Study Chair
CCOP - Columbus
United States: Federal Government
CDR0000269100
NCT00053053
December 2002
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
| MBCCOP - Hawaii | Honolulu, Hawaii 96813 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| Abington Memorial Hospital | Abington, Pennsylvania 19001 |
| Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
| CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
| CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
| CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
| CCOP - North Shore University Hospital | Manhasset, New York 11030 |
| CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
| Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis, Indiana 46202 |
| CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
| CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
| Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
| Bloomington Hospital | Bloomington, Indiana 47402 |
| Yale Comprehensive Cancer Center | New Haven, Connecticut 06520-8028 |
| St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction, Colorado 81502 |
| Methodist Cancer Center at Methodist Hospital | Indianapolis, Indiana 46202 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
| Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse, Wisconsin 54601 |
| Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
| CCOP - Ochsner | New Orleans, Louisiana 70121 |
| Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
| Cancer Center at the University of Virginia | Charlottesville, Virginia 22908 |
| Providence Saint Joseph Medical Center - Burbank | Burbank, California 91505 |
| Saint Agnes Cancer Center | Fresno, California 93720 |
| Sutter Health Western Division Cancer Research Group | Greenbrae, California 94904 |
| Veterans Affairs Medical Center - Long Beach | Long Beach, California 90822 |
| CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
| O'Connor Hospital | San Jose, California 95128 |
| CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California 95403 |
| Memorial Hospital Cancer Center | Colorado Springs, Colorado 80909 |
| Florida Radiation Oncology Group | Orange Park, Florida 32073 |
| Gulf Coast Cancer Treatment Center | Panama City, Florida 32405-4587 |
| Sarasota Radiation and Medical Oncology Center | Sarasota, Florida 34233 |
| Northwest Community Hospital | Arlington Heights, Illinois 60005 |
| Lutheran General Cancer Care Center | Park Ridge, Illinois 60068 |
| Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
| CCOP - Central Illinois | Springfield, Illinois 62526 |
| Harbor Hospital Center | Baltimore, Maryland 21225 |
| Cape Cod Hospital | Hyannis, Massachusetts 02601 |
| Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain, Massachusetts 02130 |
| CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| Elliot Regional Cancer Center | Manchester, New Hampshire 03103 |
| John F. Kennedy Medical Center | Edison, New Jersey 08818 |
| Newark Beth Israel Medical Center | Newark, New Jersey 07112 |
| Community Medical Center | Toms River, New Jersey 08755 |
| New York Methodist Hospital | Brooklyn, New York 11215-3609 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
| Mercy Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15219 |
| Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
| Mercy Hospital Cancer Center - Scranton | Scranton, Pennsylvania 18501 |
| CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| Harrington Cancer Center | Amarillo, Texas 79106 |
| University of Texas Medical Branch | Galveston, Texas 77555-1329 |
| Joe Arrington Cancer Research and Treatment Center | Lubbock, Texas 79410-1894 |
| Dixie Regional Medical Center | Saint George, Utah 84770 |
| LDS Hospital | Salt Lake City, Utah 84143 |
| Deaconess Medical Center | Spokane, Washington 99210-0248 |
| Yakima Valley Memorial Hospital | Yakima, Washington 98902 |
| St. Vincent Hospital | Green Bay, Wisconsin 54307-3508 |
| University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
| Community Memorial Hospital | Menomonee Falls, Wisconsin 53051 |
| Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee, Wisconsin 53295 |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
| University of Miami Sylvester Comprehensive Cancer Center | Miami, Florida 33136 |
| CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
| Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus, Ohio 43210-1240 |
| CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
| Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | Nashville, Tennessee 37232-2516 |
| CCOP - Scott and White Hospital | Temple, Texas 76508 |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
| CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay, Wisconsin 54301 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| MBCCOP - Gulf Coast | Mobile, Alabama 36688 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
| Naval Medical Center - San Diego | San Diego, California 92134-3202 |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
| CCOP - Oklahoma | Tulsa, Oklahoma 74136 |
| Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
| Foundation for Cancer Research and Education | Phoenix, Arizona 85013 |
| Bay Medical Center | Panama City, Florida 32401 |
| Peninsula Regional Medical Center | Salisbury, Maryland 21801 |
| MidMichigan Medical Center - Midland | Midland, Michigan 48670 |
| Monmouth Medical Center | Long Branch, New Jersey 07740-6395 |
| University of Utah Health Sciences Center | Salt Lake City, Utah 84132 |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
| UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
| CCOP - Beaumont | Royal Oak, Michigan 48073-6769 |
| Hillman Cancer Center at University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15236 |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
| Tulane Cancer Center at Tulane University Hospital and Clinic | New Orleans, Louisiana 70112 |
| Cancer Research Center at Boston Medical Center | Boston, Massachusetts 02118 |
| Herbert Irving Comprehensive Cancer Center at Columbia University | New York, New York 10032 |
| James Graham Brown Cancer Center at University of Louisville | Louisville, Kentucky 40202 |
| Roger Williams Medical Center | Providence, Rhode Island 02908-4735 |
| Fairview University Medical Center - University Campus | Minneapolis, Minnesota 55455 |
| SUNY Downstate Medical Center | Brooklyn, New York 11203 |
| McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
| Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University | Cleveland, Ohio 44106 |
| Oklahoma University Medical Center | Oklahoma City, Oklahoma 73104 |
| M.D. Anderson Cancer Center at University of Texas | Houston, Texas 77030 |
| DCH Cancer Treatment Center | Tuscaloosa, Alabama 35401 |
| Radiation Medical Group, Incorporated | San Diego, California 92101 |
| Holmes Regional Medical Center | Melbourne, Florida 32901-3276 |
| Regional Radiation Oncology Center at Rome | Rome, Georgia 30165 |
| Central Baptist Hospital | Lexington, Kentucky 40503 |
| Riverhill Radiation Oncology | Yonkers, New York 10701 |
| Trinity Cancer Care Center | Minot, North Dakota 58701 |
| CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
| St. Luke's Hospital Cancer Center | Bethlehem, Pennsylvania 18015 |
| Mercy Fitzgerald Hospital | Darby, Pennsylvania 19023 |
| Wilford Hall Medical Center | Lackland Air Force Base, Texas 78236-5300 |
| RMH Regional Cancer Center | Harrisonburg, Virginia 22801 |
| Waukesha Memorial Hospital Regional Cancer Center | Waukesha, Wisconsin 53188 |
| Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham, Alabama 35294 |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda, California 92354 |
| University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
| Baptist-South Miami Regional Cancer Program | Miami, Florida 33176 |
| Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
| Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | Baltimore, Maryland 21215 |
| SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
| Naval Medical Center - Portsmouth | Portsmouth, Virginia 23708-2197 |
| Massey Cancer Center at Virginia Commonwealth University | Richmond, Virginia 23298-0037 |
| Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha | Omaha, Nebraska 68114-4199 |
| CCOP - Marshfield Clinic Research Foundation | Marshfield, Wisconsin 54449 |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
| Comprehensive Cancer Institute | Huntsville, Alabama 35801 |
| Torrance Memorial Medical Center | Torrance, California 90505 |
| Sibley Memorial Hospital | Washington, District of Columbia 20016 |
| 21st Century Oncology - Fort Myers | Fort Myers, Florida 33901-8082 |
| Tallahassee Memorial Hospital | Tallahassee, Florida 32308 |
| Oncology Institute of Greater Lafayette | Lafayette, Indiana 47904 |
| Cancer Center at Lexington Clinic | Lexington, Kentucky 40504 |
| St. Agnes Cancer Center | Baltimore, Maryland 21229 |
| Lourdes Regional Cancer Center | Binghamton, New York 13905 |
| North Shore Radiation Oncology | Setauket, New York 11733 |
| Batte Cancer Center at Northeast Medical Center | Concord, North Carolina 28025 |
| Cancer Center at Christ Hospital | Cincinnati, Ohio 45219 |
| Parma Community General Hospital | Parma, Ohio 44129 |
| Vermont Cancer Center at University of Vermont | Burlington, Vermont 05405-0075 |
| Cancer Institute at Virginia Mason Medical Center | Seattle, Washington 98111 |
| William Beaumont Hospital - Royal Oak Campus | Royal Oak, Michigan 48073 |
| Fox Chase Virtua Health Cancer Program - Marlton | Marlton, New Jersey 08053 |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
| Josephine Ford Cancer Center at Henry Ford Health System | Detroit, Michigan 48202 |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha, Nebraska 68198-7680 |
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
| General Robert Huyser Cancer Center at David Grant Medical Center | Travis Air Force Base, California 94535 |
| Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital | Greenville, North Carolina 27858-4354 |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
| Maine Medical Center - Bramhall Campus | Portland, Maine 04102 |
| Mount Diablo Regional Cancer Center | Concord, California 94524-4110 |
| Ingalls Cancer Care Center at Ingalls Memorial Hospital | Harvey, Illinois 60426 |
| Mary Bird Perkins Cancer Center - Baton Rouge | Baton Rouge, Louisiana 70809 |
| Upper Michigan Cancer Center at Marquette General Hospital | Marquette, Michigan 49855 |
| Fox Chase Cancer Center at St. Francis Medical Center | Trenton, New Jersey 08629 |
| Delaware County Regional Cancer Center at Delaware County Memorial Hospital | Drexel Hill, Pennsylvania 19026 |
| DeCesaris Cancer Institute at Anne Arundel Medical Center | Annapolis, Maryland 21401 |
| California Cancer Center - Woodward Park Office | Fresno, California 93720 |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa, Florida 33612 |
| Cancer Center at Ball Memorial Hospital | Muncie, Indiana 47303 |
| Wendt Regional Cancer Center at Finley Hospital | Dubuque, Iowa 52001 |
| Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County | Madisonville, Kentucky 42431 |
| Great Lakes Cancer Institute at McLaren Regional Medical Center | Flint, Michigan 48532 |
| South Jersey Healthcare Regional Cancer Center | Millville, New Jersey 08332 |
| Atlantic City Medical Center - Mainland Division | Pomona, New Jersey 08240 |
| Akron City Hospital at Summa Health System | Akron, Ohio 44304 |
| LaFortune Cancer Center at St. John Health System | Tulsa, Oklahoma 74104 |
| John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital | Allentown, Pennsylvania 18105 |
| Allegheny Cancer Center at Allegheny General Hospital | Pittsburgh, Pennsylvania 15212 |
| Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224-1791 |
| Bon Secours Cancer Care at St. Mary's Hospital | Richmond, Virginia 23226 |
| Vince Lombardi Cancer Clinic at St. Luke's Medical Center | Milwaukee, Wisconsin 53215 |
| All Saints Cancer Center at All Saints Healthcare | Racine, Wisconsin 53405 |
| Schiffler Cancer Center at Wheeling Hospital | Wheeling, West Virginia 26003 |
| Saint Louis University Cancer Center | Saint Louis, Missouri 63110 |
| Huntington Cancer Center at Huntington Hospital | Pasadena, California 91105 |
| St. Joseph's Regional Cancer Center | Stockton, California 95204 |
| Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center | Pomona, California 91767 |
| Hospital of Saint Raphael | New Haven, Connecticut 06511 |
| St. John's Cancer Center at St. John's Medical Center | Anderson, Indiana 46016 |
| York Cancer Center at Wellspan Health | York, Pennsylvania 17403 |
| Community Cancer Center at Rutland Regional Medical Center | Rutland, Vermont 05701 |
| Frank C. Love Cancer Institute at St. Anthony Hospital | Oklahoma City, Oklahoma 73101 |
| Montgomery Cancer Center | Montgomery, Alabama 36106-3657 |
| Radiation Oncology Centers - Sacramento | Sacramento, California 95816 |
| Louisville Radiation Oncology Center at Caritas Regional Cancer Center | Louisville, Kentucky 40215 |
| Beth Israel Medical Center - Philipps Ambulatory Care Center | New York, New York 10003 |
| Wilkes-Barre General Hospital | Wilkes-Barre, Pennsylvania 18764-0001 |
| West Tennessee Cancer Center at Jackson-Madison County General Hospital | Jackson, Tennessee 38301 |
| Cancer Center at Greater Baltimore Medical Center | Baltimore, Maryland 21204 |
| Valley Hospital - Ridgewood | Ridgewood, New Jersey 07450 |
| Esther Marie Hatton Cancer Care Center at St. Elizabeth Medical Center | Edgewood, Kentucky 41017 |
| Dale and Frances Hughes Cancer Center at Pocono Medical Center | East Stroudsburg, Pennsylvania 18301 |
| John B. Amos Community Cancer Center | Columbus, Georgia 31902 |
| NSMC Cancer Center - Peabody | Peabody, Massachusetts 01960 |
| Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center | Plattsburgh, New York 12901 |
| William Beaumont Hospital - Troy Campus | Troy, Michigan 48085 |
| University Medical Center at Princeton | Princeton, New Jersey 08540 |
| Associated Radiologists, P.A. at Warren Radiation Therapy Center | Warren, New Jersey 07059 |
| Radiation Oncology Associates, PA | Albuquerque, New Mexico 87109 |
| Finger Lakes Radiation Oncology Center at Clifton Springs Hospital and clinic | Clifton Springs, New York 14432 |
| Arlington Cancer Center - Arlington | Arlington, Texas 76012 |
| Columbia St. Mary's - Columbia Campus | Milwaukee, Wisconsin 53211 |
