S9908: Glutamine in Treating Mucositis Caused by Radiation Therapy in Patients With Newly Diagnosed Cancer of the Mouth or Throat
Cancer-related Problem/Condition, Head and Neck Cancer, Pain
About this trial
This is an interventional supportive care trial for Cancer-related Problem/Condition focused on measuring oral complications of radiation therapy, pain, radiation toxicity, stage I squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage I squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx
Eligibility Criteria
DISEASE CHARACTERISTICS: 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
Sites / Locations
- MBCCOP - Gulf Coast
- CCOP - Western Regional, Arizona
- Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
- Veterans Affairs Medical Center - Tucson
- Arizona Cancer Center at University of Arizona Health Sciences Center
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Veterans Affairs Medical Center - Little Rock (McClellan)
- City of Hope Comprehensive Cancer Center
- Veterans Affairs Medical Center - Long Beach
- USC/Norris Comprehensive Cancer Center and Hospital
- Veterans Affairs Medical Center - West Los Angeles
- Jonsson Comprehensive Cancer Center, UCLA
- Veterans Affairs Outpatient Clinic - Martinez
- CCOP - Bay Area Tumor Institute
- Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
- University of California Davis Cancer Center
- UCSF Comprehensive Cancer Center
- CCOP - Santa Rosa Memorial Hospital
- David Grant Medical Center
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
- Veterans Affairs Medical Center - Denver
- MBCCOP - Howard University Cancer Center
- Veterans Affairs Medical Center - Tampa (Haley)
- CCOP - Atlanta Regional
- Dwight David Eisenhower Army Medical Center
- MBCCOP - Hawaii
- Tripler Army Medical Center
- MBCCOP - University of Illinois at Chicago
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
- CCOP - Central Illinois
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Genesis Regional Cancer Center at Genesis Medical Center
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- CCOP - Wichita
- Veterans Affairs Medical Center - Wichita
- Veterans Affairs Medical Center - Lexington
- Markey Cancer Center at University of Kentucky Chandler Medical Center
- MBCCOP - LSU Health Sciences Center
- Tulane Cancer Center at Tulane University Hospital and Clinic
- Veterans Affairs Medical Center - New Orleans
- Veterans Affairs Medical Center - Shreveport
- Louisiana State University Health Sciences Center - Shreveport
- Cancer Research Center at Boston Medical Center
- Veterans Affairs Medical Center - Ann Arbor
- CCOP - Michigan Cancer Research Consortium
- University of Michigan Comprehensive Cancer Center
- Barbara Ann Karmanos Cancer Institute
- Veterans Affairs Medical Center - Detroit
- Josephine Ford Cancer Center at Henry Ford Hospital
- CCOP - Grand Rapids
- CCOP - Beaumont
- Providence Cancer Institute at Providence Hospital
- CCOP - Duluth
- University of Mississippi Medical Center
- Veterans Affairs Medical Center - Jackson
- Keesler Medical Center - Keesler Air Force Base
- CCOP - Kansas City
- St. Louis University Hospital Cancer Center
- CCOP - St. Louis-Cape Girardeau
- CCOP - Cancer Research for the Ozarks
- CCOP - Montana Cancer Consortium
- Veterans Affairs Medical Center - East Orange
- Veterans Affairs Medical Center - Albuquerque
- MBCCOP - University of New Mexico HSC
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
- Herbert Irving Comprehensive Cancer Center at Columbia University
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Veterans Affairs Medical Center - Salisbury
- CCOP - Southeast Cancer Control Consortium
- Veterans Affairs Medical Center - Cincinnati
- Charles M. Barrett Cancer Center at University Hospital
- Cleveland Clinic Taussig Cancer Center
- CCOP - Columbus
- Arthur G. James Cancer Hospital - Ohio State University
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- CCOP - Toledo Community Hospital
- Oklahoma University Medical Center
- Cancer Institute at Oregon Health and Science University
- Veterans Affairs Medical Center - Portland
- CCOP - Columbia River Oncology Program
- Veterans Affairs Medical Center - Charleston
- Hollings Cancer Center at Medical University of South Carolina
- CCOP - Greenville
- CCOP - Upstate Carolina
- Danville Radiation Therapy Center
- University of Tennessee Cancer Institute
- Harrington Cancer Center
- Veterans Affairs Medical Center - Amarillo
- Veterans Affairs Medical Center - Dallas
- Brooke Army Medical Center
- University of Texas Medical Branch
- University of Texas - MD Anderson Cancer Center
- Veterans Affairs Medical Center - Houston
- University of Texas Health Science Center at San Antonio
- Veterans Affairs Medical Center - San Antonio (Murphy)
- Veterans Affairs Medical Center - Temple
- CCOP - Scott and White Hospital
- Huntsman Cancer Institute
- Veterans Affairs Medical Center - Salt Lake City
- CCOP - Virginia Mason Research Center
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- Veterans Affairs Medical Center - Seattle
- CCOP - Northwest
- Madigan Army Medical Center
- Hospital for Sick Children
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
L-glutamine in suspension + radiation
Placebo in suspension + radiation
20 cc three times daily for 60 days plus radiation therapy.
20 cc three times daily for 60 days plus radiation therapy.