S9908: Glutamine in Treating Mucositis Caused by Radiation Therapy in Patients With Newly Diagnosed Cancer of the Mouth or Throat
NCT ID: NCT00006994
Last Updated: 2015-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
23 participants
INTERVENTIONAL
2001-11-30
2006-04-30
Brief Summary
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PURPOSE: Randomized phase III trial to determine the effectiveness of glutamine in treating patients who develop mucositis following radiation therapy for newly diagnosed cancer of the mouth or throat.
Detailed Description
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* Compare the efficacy of L-glutamine vs placebo, in terms of maximum mucositis toxic effects and worst reported mouth pain during and after high-dose radiotherapy, in patients with newly diagnosed, previously untreated squamous cell cancer of the oral cavity or oropharynx.
* Compare the duration of severe mucositis in patients treated with these regimens.
* Compare the radiotherapy delay in patients treated with these regimens.
* Compare weight loss in patients treated with these regimens.
* Compare the toxic effects of these two regimens in these patients.
* Compare patient-reported mouth pain success rate in patients treated with these regimens.
* Determine the compliance of patients treated with this drug regimen.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to concurrent cisplatin or carboplatin (yes vs no), concurrent fluorouracil (yes vs no), and presence of feeding tube (yes vs no). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Beginning 4 to 7 days prior to radiotherapy, patients receive oral L-glutamine 3 times daily for 60-80 days. Patients receive concurrent high-dose radiotherapy for approximately 6 weeks.
* Arm II: Patients receive oral placebo and high-dose radiotherapy as in arm I. In both arms, treatment continues in the absence of unacceptable toxicity.
Patients are followed for 2 weeks.
PROJECTED ACCRUAL: A total of 158 patients (79 per treatment arm) will be accrued for this study within 2.5 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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L-glutamine in suspension + radiation
20 cc three times daily for 60 days plus radiation therapy.
glutamine
20 cc three times daily for 60 days
radiation therapy
Per institutional standard; minimum of 6,000 cGy with a daily dose of 180-200 cGy.
Placebo in suspension + radiation
20 cc three times daily for 60 days plus radiation therapy.
radiation therapy
Per institutional standard; minimum of 6,000 cGy with a daily dose of 180-200 cGy.
l-glutamine placebo
20 cc three times daily for 60 days
Interventions
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glutamine
20 cc three times daily for 60 days
radiation therapy
Per institutional standard; minimum of 6,000 cGy with a daily dose of 180-200 cGy.
l-glutamine placebo
20 cc three times daily for 60 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed, previously untreated squamous cell cancer of the oral cavity or oropharynx (T1-T4, any N, M0)
* Must be scheduled to receive high-dose radiotherapy
* Not concurrently receiving or planning to receive treatment on any other Southwest Oncology Group protocol
PATIENT CHARACTERISTICS:
Age:
* 18 to 90
Performance status:
* Zubrod 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer currently in complete remission
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
* Concurrent cisplatin, carboplatin, or fluorouracil allowed
* No other concurrent chemotherapy during study and for at least 3 weeks after study radiotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* See Disease Characteristics
Surgery:
* Not specified
Other:
* No concurrent amifostine during and for 2 weeks after study radiotherapy
18 Years
90 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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V. S. Klimberg, MD
Role: STUDY_CHAIR
University of Arkansas
Locations
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MBCCOP - Gulf Coast
Mobile, Alabama, United States
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Veterans Affairs Medical Center - Long Beach
Long Beach, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States
David Grant Medical Center
Travis Air Force Base, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, United States
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, United States
CCOP - Atlanta Regional
Atlanta, Georgia, United States
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, United States
MBCCOP - Hawaii
Honolulu, Hawaii, United States
Tripler Army Medical Center
Honolulu, Hawaii, United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States
CCOP - Central Illinois
Decatur, Illinois, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States
Genesis Regional Cancer Center at Genesis Medical Center
Davenport, Iowa, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States
Tulane Cancer Center at Tulane University Hospital and Clinic
New Orleans, Louisiana, United States
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, United States
CCOP - Beaumont
Royal Oak, Michigan, United States
Providence Cancer Institute at Providence Hospital
Southfield, Michigan, United States
CCOP - Duluth
Duluth, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, United States
Keesler Medical Center - Keesler Air Force Base
Keesler Air Force Base, Mississippi, United States
CCOP - Kansas City
Kansas City, Missouri, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
St. Louis University Hospital Cancer Center
St Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Veterans Affairs Medical Center - Salisbury
Salisbury, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States
CCOP - Dayton
Dayton, Ohio, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, United States
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
CCOP - Greenville
Greenville, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Danville Radiation Therapy Center
Memphis, Tennessee, United States
University of Tennessee Cancer Institute
Memphis, Tennessee, United States
Harrington Cancer Center
Amarillo, Texas, United States
Veterans Affairs Medical Center - Amarillo
Amarillo, Texas, United States
Veterans Affairs Medical Center - Dallas
Dallas, Texas, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Veterans Affairs Medical Center - Houston
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States
Veterans Affairs Medical Center - Temple
Temple, Texas, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States
CCOP - Northwest
Tacoma, Washington, United States
Madigan Army Medical Center
Tacoma, Washington, United States
Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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Other Identifiers
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S9908
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000068353
Identifier Type: -
Identifier Source: org_study_id