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

Primary Purpose

Cachexia, Lymphoma, Lymphoproliferative Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Juven
Non-Juven Supplement
Sponsored by
Radiation Therapy Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cachexia focused on measuring 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

Eligibility Criteria

17 Years - 120 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Comprehensive Cancer Center at University of Alabama at Birmingham
  • Comprehensive Cancer Institute
  • MBCCOP - Gulf Coast
  • Montgomery Cancer Center
  • DCH Cancer Treatment Center
  • Foundation for Cancer Research and Education
  • Providence Saint Joseph Medical Center - Burbank
  • Mount Diablo Regional Cancer Center
  • City of Hope Comprehensive Cancer Center
  • California Cancer Center - Woodward Park Office
  • Saint Agnes Cancer Center
  • Sutter Health Western Division Cancer Research Group
  • Loma Linda University Cancer Institute at Loma Linda University Medical Center
  • Veterans Affairs Medical Center - Long Beach
  • USC/Norris Comprehensive Cancer Center and Hospital
  • Jonsson Comprehensive Cancer Center at UCLA
  • CCOP - Bay Area Tumor Institute
  • Huntington Cancer Center at Huntington Hospital
  • Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
  • Radiation Oncology Centers - Sacramento
  • Radiation Medical Group, Incorporated
  • Naval Medical Center - San Diego
  • UCSF Comprehensive Cancer Center
  • O'Connor Hospital
  • CCOP - Santa Rosa Memorial Hospital
  • St. Joseph's Regional Cancer Center
  • Torrance Memorial Medical Center
  • General Robert Huyser Cancer Center at David Grant Medical Center
  • Memorial Hospital Cancer Center
  • University of Colorado Cancer Center at University of Colorado Health Sciences Center
  • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
  • Hospital of Saint Raphael
  • Yale Comprehensive Cancer Center
  • CCOP - Christiana Care Health Services
  • Sibley Memorial Hospital
  • 21st Century Oncology - Fort Myers
  • University of Florida Shands Cancer Center
  • Florida Radiation Oncology Group
  • Holmes Regional Medical Center
  • CCOP - Mount Sinai Medical Center
  • University of Miami Sylvester Comprehensive Cancer Center
  • Baptist-South Miami Regional Cancer Program
  • Bay Medical Center
  • Gulf Coast Cancer Treatment Center
  • Sarasota Radiation and Medical Oncology Center
  • Tallahassee Memorial Hospital
  • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
  • Winship Cancer Institute of Emory University
  • CCOP - Atlanta Regional
  • John B. Amos Community Cancer Center
  • Regional Radiation Oncology Center at Rome
  • MBCCOP - Hawaii
  • Northwest Community Hospital
  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  • CCOP - Central Illinois
  • Ingalls Cancer Care Center at Ingalls Memorial Hospital
  • Cardinal Bernardin Cancer Center at Loyola University Medical Center
  • Lutheran General Cancer Care Center
  • Methodist Medical Center of Illinois
  • St. John's Cancer Center at St. John's Medical Center
  • Bloomington Hospital
  • Veterans Affairs Medical Center - Indianapolis (Roudebush)
  • Methodist Cancer Center at Methodist Hospital
  • Oncology Institute of Greater Lafayette
  • Cancer Center at Ball Memorial Hospital
  • CCOP - Northern Indiana CR Consortium
  • Wendt Regional Cancer Center at Finley Hospital
  • Esther Marie Hatton Cancer Care Center at St. Elizabeth Medical Center
  • Central Baptist Hospital
  • Cancer Center at Lexington Clinic
  • Markey Cancer Center at University of Kentucky Chandler Medical Center
  • James Graham Brown Cancer Center at University of Louisville
  • Louisville Radiation Oncology Center at Caritas Regional Cancer Center
  • Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
  • Mary Bird Perkins Cancer Center - Baton Rouge
  • Tulane Cancer Center at Tulane University Hospital and Clinic
  • MBCCOP - LSU Health Sciences Center
  • CCOP - Ochsner
  • Maine Medical Center - Bramhall Campus
  • DeCesaris Cancer Institute at Anne Arundel Medical Center
  • Greenebaum Cancer Center at University of Maryland Medical Center
  • Cancer Center at Greater Baltimore Medical Center
  • Harbor Hospital Center
  • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
  • St. Agnes Cancer Center
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Peninsula Regional Medical Center
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • Cancer Research Center at Boston Medical Center
  • Cape Cod Hospital
  • Veterans Affairs Medical Center - Boston (Jamaica Plain)
  • NSMC Cancer Center - Peabody
  • CCOP - Michigan Cancer Research Consortium
  • University of Michigan Comprehensive Cancer Center
  • Barbara Ann Karmanos Cancer Institute
  • Josephine Ford Cancer Center at Henry Ford Health System
  • Great Lakes Cancer Institute at McLaren Regional Medical Center
  • CCOP - Kalamazoo
  • Upper Michigan Cancer Center at Marquette General Hospital
  • MidMichigan Medical Center - Midland
  • CCOP - Beaumont
  • William Beaumont Hospital - Royal Oak Campus
  • William Beaumont Hospital - Troy Campus
  • Fairview University Medical Center - University Campus
  • Mayo Clinic Cancer Center
  • CCOP - Metro-Minnesota
  • Ellis Fischel Cancer Center at University of Missouri - Columbia
  • CCOP - Kansas City
  • Saint Louis University Cancer Center
  • CCOP - Cancer Research for the Ozarks
  • Siteman Cancer Center at Barnes-Jewish Hospital
  • CCOP - Montana Cancer Consortium
  • CCOP - Missouri Valley Cancer Consortium
  • Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
  • CCOP - Southern Nevada Cancer Research Foundation
  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
  • Elliot Regional Cancer Center
  • Veterans Affairs Medical Center - East Orange
  • John F. Kennedy Medical Center
  • Monmouth Medical Center
  • Fox Chase Virtua Health Cancer Program - Marlton
  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
  • Newark Beth Israel Medical Center
  • Atlantic City Medical Center - Mainland Division
  • University Medical Center at Princeton
  • Valley Hospital - Ridgewood
  • Community Medical Center
  • Fox Chase Cancer Center at St. Francis Medical Center
  • South Jersey Healthcare Regional Cancer Center
  • Associated Radiologists, P.A. at Warren Radiation Therapy Center
  • Radiation Oncology Associates, PA
  • Lourdes Regional Cancer Center
  • SUNY Downstate Medical Center
  • New York Methodist Hospital
  • Finger Lakes Radiation Oncology Center at Clifton Springs Hospital and clinic
  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
  • CCOP - North Shore University Hospital
  • Beth Israel Medical Center - Philipps Ambulatory Care Center
  • Memorial Sloan-Kettering Cancer Center
  • Herbert Irving Comprehensive Cancer Center at Columbia University
  • Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center
  • James P. Wilmot Cancer Center at University of Rochester Medical Center
  • North Shore Radiation Oncology
  • SUNY Upstate Medical University Hospital
  • Riverhill Radiation Oncology
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  • Batte Cancer Center at Northeast Medical Center
  • CCOP - Southeast Cancer Control Consortium
  • Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
  • Comprehensive Cancer Center at Wake Forest University
  • Trinity Cancer Care Center
  • McDowell Cancer Center at Akron General Medical Center
  • Akron City Hospital at Summa Health System
  • Cancer Center at Christ Hospital
  • Charles M. Barrett Cancer Center at University Hospital
  • Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
  • Cleveland Clinic Taussig Cancer Center
  • CCOP - Columbus
  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
  • CCOP - Dayton
  • Parma Community General Hospital
  • CCOP - Toledo Community Hospital
  • Frank C. Love Cancer Institute at St. Anthony Hospital
  • Oklahoma University Medical Center
  • LaFortune Cancer Center at St. John Health System
  • CCOP - Oklahoma
  • CCOP - Columbia River Oncology Program
  • Abington Memorial Hospital
  • John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
  • St. Luke's Hospital Cancer Center
  • Geisinger Medical Center
  • Mercy Fitzgerald Hospital
  • Delaware County Regional Cancer Center at Delaware County Memorial Hospital
  • Dale and Frances Hughes Cancer Center at Pocono Medical Center
  • Penn State Cancer Institute at Milton S. Hershey Medical Center
  • Abramson Cancer Center of the University of Pennsylvania
  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
  • Fox Chase Cancer Center
  • Albert Einstein Cancer Center
  • Allegheny Cancer Center at Allegheny General Hospital
  • Mercy Hospital of Pittsburgh
  • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
  • Hillman Cancer Center at University of Pittsburgh Cancer Institute
  • Reading Hospital and Medical Center
  • Mercy Hospital Cancer Center - Scranton
  • Wilkes-Barre General Hospital
  • CCOP - MainLine Health
  • York Cancer Center at Wellspan Health
  • Roger Williams Medical Center
  • CCOP - Greenville
  • CCOP - Upstate Carolina
  • Rapid City Regional Hospital
  • West Tennessee Cancer Center at Jackson-Madison County General Hospital
  • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
  • Harrington Cancer Center
  • Arlington Cancer Center - Arlington
  • University of Texas Medical Branch
  • M.D. Anderson Cancer Center at University of Texas
  • Wilford Hall Medical Center
  • Joe Arrington Cancer Research and Treatment Center
  • University of Texas Health Science Center at San Antonio
  • CCOP - Scott and White Hospital
  • Utah Valley Regional Medical Center - Provo
  • Dixie Regional Medical Center
  • University of Utah Health Sciences Center
  • LDS Hospital
  • Vermont Cancer Center at University of Vermont
  • Community Cancer Center at Rutland Regional Medical Center
  • Cancer Center at the University of Virginia
  • RMH Regional Cancer Center
  • Naval Medical Center - Portsmouth
  • Bon Secours Cancer Care at St. Mary's Hospital
  • Massey Cancer Center at Virginia Commonwealth University
  • Cancer Institute at Virginia Mason Medical Center
  • Deaconess Medical Center
  • Yakima Valley Memorial Hospital
  • Schiffler Cancer Center at Wheeling Hospital
  • CCOP - St. Vincent Hospital Cancer Center, Green Bay
  • St. Vincent Hospital
  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
  • University of Wisconsin Comprehensive Cancer Center
  • CCOP - Marshfield Clinic Research Foundation
  • Marshfield Clinic - Marshfield Center
  • Community Memorial Hospital
  • Columbia St. Mary's - Columbia Campus
  • Vince Lombardi Cancer Clinic at St. Luke's Medical Center
  • Veterans Affairs Medical Center - Milwaukee (Zablocki)
  • All Saints Cancer Center at All Saints Healthcare
  • Waukesha Memorial Hospital Regional Cancer Center
  • Tom Baker Cancer Centre - Calgary
  • Cross Cancer Institute
  • Doctor Leon Richard Oncology Centre
  • Saint John Regional Hospital
  • Newfoundland Cancer Treatment and Research Foundation
  • Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre
  • Margaret and Charles Juravinski Cancer Centre
  • Cancer Centre of Southeastern Ontario
  • London Regional Cancer Program at London Health Sciences Centre
  • Ottawa Hospital Regional Cancer Centre - General Campus
  • Northeastern Ontario Regional Cancer Centre
  • Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
  • Toronto Sunnybrook Regional Cancer Centre
  • Princess Margaret Hospital
  • Centre Hospitalier de l'Universite de Montreal
  • McGill Cancer Centre at McGill University
  • Centre Hospitalier Universitaire de Quebec
  • CHUS-Hopital Fleurimont
  • Allan Blair Cancer Centre at Pasqua Hospital
  • Saskatoon Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Juven supplement

Non-Juven supplement

Arm Description

Juven nutritional supplement given twice a day for 8 weeks

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

Outcomes

Primary Outcome Measures

Lean body mass

Secondary Outcome Measures

Fatigue
Quality of Life
Body weight
Correlation between change in lean body mass and body plethysmography, bioimpedance and skin-fold measurement

Full Information

First Posted
January 27, 2003
Last Updated
December 6, 2016
Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00053053
Brief Title
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

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
472 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Juven supplement
Arm Type
Experimental
Arm Description
Juven nutritional supplement given twice a day for 8 weeks
Arm Title
Non-Juven supplement
Arm Type
Active Comparator
Arm Description
Non-Juven nutritional supplement given twice a day for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Juven
Intervention Type
Dietary Supplement
Intervention Name(s)
Non-Juven Supplement
Primary Outcome Measure Information:
Title
Lean body mass
Time Frame
Study entry to 8 weeks
Secondary Outcome Measure Information:
Title
Fatigue
Time Frame
Study entry to 8 weeks
Title
Quality of Life
Time Frame
Study entry to 8 weeks
Title
Body weight
Time Frame
Study entry to 8 weeks
Title
Correlation between change in lean body mass and body plethysmography, bioimpedance and skin-fold measurement
Time Frame
Study entry to 8 weeks

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
18293016
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.
Results Reference
result

Learn more about this trial

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

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