S9908: Glutamine in Treating Mucositis Caused by Radiation Therapy in Patients With Newly Diagnosed Cancer of the Mouth or Throat
- Conditions
- Cancer-related Problem/ConditionPainHead and Neck Cancer
- Interventions
- Registration Number
- NCT00006994
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Glutamine may be effective in decreasing side effects, such as inflammation of the mouth and throat, caused by radiation therapy. The effectiveness of glutamine for mucositis is not yet known.
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
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 23
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description L-glutamine in suspension + radiation glutamine 20 cc three times daily for 60 days plus radiation therapy. Placebo in suspension + radiation radiation therapy 20 cc three times daily for 60 days plus radiation therapy. Placebo in suspension + radiation l-glutamine placebo 20 cc three times daily for 60 days plus radiation therapy. L-glutamine in suspension + radiation radiation therapy 20 cc three times daily for 60 days plus radiation therapy.
- Primary Outcome Measures
Name Time Method Effectiveness of L-glutamine for mucositis 2 weeks after end of radiation treatment Evaluate effectiveness of L-glutamine as compared to placebo in terms of: maximum toxicity grade during radiation treatment, mucositis toxicity grade 2 weeks after the end of radiation treatment, and patient reported worst mouth pain two weeks after the end of radiation treatment.
- Secondary Outcome Measures
Name Time Method Duration of severe mucositis, radiation treatment delay, and weight loss 2 weeks after radiation treatment Toxicities within 2 weeks after radiation treatment Compare patient reported mouth pain "success" rate at the end of radiation treatment 2 weeks after end of radiation treatment Compliance (dose taken) in patients treated with L-glutamine when given with radiation treatment 2 weeks after end of radiation treatment
Trial Locations
- Locations (107)
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
Keesler Medical Center - Keesler Air Force Base
🇺🇸Keesler AFB, Mississippi, United States
Veterans Affairs Outpatient Clinic - Martinez
🇺🇸Martinez, California, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
🇺🇸Chicago, Illinois, United States
Louisiana State University Health Sciences Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
CCOP - Beaumont
🇺🇸Royal Oak, Michigan, United States
Veterans Affairs Medical Center - Jackson
🇺🇸Jackson, Mississippi, United States
Veterans Affairs Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Veterans Affairs Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Veterans Affairs Medical Center - Salt Lake City
🇺🇸Salt Lake City, Utah, United States
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, 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
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
David Grant Medical Center
🇺🇸Travis Air Force Base, California, United States
MBCCOP - Howard University Cancer Center
🇺🇸Washington, District of Columbia, United States
Dwight David Eisenhower Army Medical Center
🇺🇸Fort Gordon, Georgia, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
MBCCOP - Hawaii
🇺🇸Honolulu, Hawaii, United States
MBCCOP - University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
🇺🇸Hines, Illinois, United States
Veterans Affairs Medical Center - Lexington
🇺🇸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
Cancer Research Center at Boston Medical Center
🇺🇸Boston, Massachusetts, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
Providence Cancer Institute at Providence Hospital
🇺🇸Southfield, Michigan, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸Saint Louis, Missouri, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
St. Louis University Hospital Cancer Center
🇺🇸Saint Louis, Missouri, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
🇺🇸San Antonio, Texas, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Tripler Army Medical Center
🇺🇸Honolulu, Hawaii, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Veterans Affairs Medical Center - Wichita
🇺🇸Wichita, Kansas, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Genesis Regional Cancer Center at Genesis Medical Center
🇺🇸Davenport, Iowa, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
🇺🇸New York, New York, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
🇺🇸New York, New York, 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
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 - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, 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
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Danville Radiation Therapy Center
🇺🇸Memphis, Tennessee, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Veterans Affairs Medical Center - Temple
🇺🇸Temple, Texas, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Charleston
🇺🇸Charleston, South Carolina, United States
University of Tennessee Cancer Institute
🇺🇸Memphis, Tennessee, United States
Veterans Affairs Medical Center - Amarillo
🇺🇸Amarillo, Texas, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Harrington Cancer Center
🇺🇸Amarillo, Texas, United States
Veterans Affairs Medical Center - Houston
🇺🇸Houston, Texas, United States
CCOP - Virginia Mason Research Center
🇺🇸Seattle, Washington, United States
CCOP - Western Regional, Arizona
🇺🇸Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
🇺🇸Phoenix, Arizona, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
University of California Davis Cancer Center
🇺🇸Sacramento, 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
Veterans Affairs Medical Center - Tampa (Haley)
🇺🇸Tampa, Florida, United States
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Veterans Affairs Medical Center - Ann Arbor
🇺🇸Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Veterans Affairs Medical Center - Detroit
🇺🇸Detroit, Michigan, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
Oklahoma University Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Portland
🇺🇸Portland, Oregon, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
CCOP - Santa Rosa Memorial Hospital
🇺🇸Santa Rosa, California, United States
Cancer Institute at Oregon Health and Science University
🇺🇸Portland, Oregon, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
🇺🇸Seattle, Washington, United States
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Markey Cancer Center at University of Kentucky Chandler Medical Center
🇺🇸Lexington, Kentucky, United States