- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006994
S9908: Glutamine in Treating Mucositis Caused by Radiation Therapy in Patients With Newly Diagnosed Cancer of the Mouth or Throat
S9908, A Double-Blind, Placebo-Controlled Trial To Study The Efficacy And Safety Of L-Glutamine (In AES0014 Delivery Vehicle) Upon Radiation Therapy-Induced Oral Mucositis In Head and Neck Cancer Patients, Phase III
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 1X8
- Hospital for Sick Children
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Alabama
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Mobile, Alabama, United States, 36607
- MBCCOP - Gulf Coast
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Arizona
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Phoenix, Arizona, United States, 85006-2726
- CCOP - Western Regional, Arizona
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Phoenix, Arizona, United States, 85012
- Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
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Tucson, Arizona, United States, 85723
- Veterans Affairs Medical Center - Tucson
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Tucson, Arizona, United States, 85724
- Arizona Cancer Center at University of Arizona Health Sciences Center
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Arkansas
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Little Rock, Arkansas, United States, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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Little Rock, Arkansas, United States, 72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
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California
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Duarte, California, United States, 91010-3000
- City of Hope Comprehensive Cancer Center
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Long Beach, California, United States, 90822
- Veterans Affairs Medical Center - Long Beach
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Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, United States, 90033
- USC/Norris Comprehensive Cancer Center and Hospital
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Los Angeles, California, United States, 90073
- Veterans Affairs Medical Center - West Los Angeles
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Martinez, California, United States, 94553
- Veterans Affairs Outpatient Clinic - Martinez
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Oakland, California, United States, 94609-3305
- CCOP - Bay Area Tumor Institute
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Orange, California, United States, 92868
- Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
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Sacramento, California, United States, 95817
- University of California Davis Cancer Center
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San Francisco, California, United States, 94143-0128
- UCSF Comprehensive Cancer Center
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Santa Rosa, California, United States, 95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base, California, United States, 94535
- David Grant Medical Center
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Colorado
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Aurora, Colorado, United States, 80010
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
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Denver, Colorado, United States, 80220
- Veterans Affairs Medical Center - Denver
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District of Columbia
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Washington, District of Columbia, United States, 20060
- MBCCOP - Howard University Cancer Center
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Florida
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Tampa, Florida, United States, 33612
- Veterans Affairs Medical Center - Tampa (Haley)
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Georgia
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Atlanta, Georgia, United States, 30342-1701
- CCOP - Atlanta Regional
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Fort Gordon, Georgia, United States, 30905-5650
- Dwight David Eisenhower Army Medical Center
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Hawaii
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Honolulu, Hawaii, United States, 96859-5000
- Tripler Army Medical Center
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Honolulu, Hawaii, United States, 96813
- MBCCOP - Hawaii
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Illinois
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Chicago, Illinois, United States, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Chicago, Illinois, United States, 60612
- MBCCOP - University of Illinois at Chicago
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Decatur, Illinois, United States, 62526
- CCOP - Central Illinois
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Hines, Illinois, United States, 60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
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Maywood, Illinois, United States, 60153-5500
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Iowa
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Davenport, Iowa, United States, 52804
- Genesis Regional Cancer Center at Genesis Medical Center
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Kansas
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Kansas City, Kansas, United States, 66160-7353
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
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Wichita, Kansas, United States, 67214-3882
- CCOP - Wichita
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Wichita, Kansas, United States, 67218
- Veterans Affairs Medical Center - Wichita
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Kentucky
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Lexington, Kentucky, United States, 40502-2236
- Veterans Affairs Medical Center - Lexington
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Lexington, Kentucky, United States, 40536-0084
- Markey Cancer Center at University of Kentucky Chandler Medical Center
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Veterans Affairs Medical Center - New Orleans
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New Orleans, Louisiana, United States, 70112
- MBCCOP - LSU Health Sciences Center
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New Orleans, Louisiana, United States, 70112
- Tulane Cancer Center at Tulane University Hospital and Clinic
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Shreveport, Louisiana, United States, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Shreveport, Louisiana, United States, 71101-4295
- Veterans Affairs Medical Center - Shreveport
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Cancer Research Center at Boston Medical Center
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Michigan
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Ann Arbor, Michigan, United States, 48105
- Veterans Affairs Medical Center - Ann Arbor
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Ann Arbor, Michigan, United States, 48106
- CCOP - Michigan Cancer Research Consortium
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Ann Arbor, Michigan, United States, 48109-0912
- University of Michigan Comprehensive Cancer Center
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Detroit, Michigan, United States, 48202
- Josephine Ford Cancer Center at Henry Ford Hospital
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Detroit, Michigan, United States, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, United States, 48201-1932
- Veterans Affairs Medical Center - Detroit
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Grand Rapids, Michigan, United States, 49503
- CCOP - Grand Rapids
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Royal Oak, Michigan, United States, 48073-6769
- CCOP - Beaumont
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Southfield, Michigan, United States, 48075
- Providence Cancer Institute at Providence Hospital
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Minnesota
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Duluth, Minnesota, United States, 55805
- CCOP - Duluth
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Mississippi
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Jackson, Mississippi, United States, 39216-4505
- University of Mississippi Medical Center
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Jackson, Mississippi, United States, 39216
- Veterans Affairs Medical Center - Jackson
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Keesler AFB, Mississippi, United States, 39534-2576
- Keesler Medical Center - Keesler Air Force Base
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Missouri
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Kansas City, Missouri, United States, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, United States, 63141
- CCOP - St. Louis-Cape Girardeau
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Saint Louis, Missouri, United States, 63110
- St. Louis University Hospital Cancer Center
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Springfield, Missouri, United States, 65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings, Montana, United States, 59101
- CCOP - Montana Cancer Consortium
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New Jersey
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East Orange, New Jersey, United States, 07018-1095
- Veterans Affairs Medical Center - East Orange
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New Mexico
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Albuquerque, New Mexico, United States, 87108-5138
- Veterans Affairs Medical Center - Albuquerque
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Albuquerque, New Mexico, United States, 87131
- MBCCOP - University of New Mexico HSC
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New York
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New York, New York, United States, 10016
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
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New York, New York, United States, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University
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Rochester, New York, United States, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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North Carolina
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Salisbury, North Carolina, United States, 28144
- Veterans Affairs Medical Center - Salisbury
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Winston-Salem, North Carolina, United States, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Ohio
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Cincinnati, Ohio, United States, 45220-2288
- Veterans Affairs Medical Center - Cincinnati
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Cincinnati, Ohio, United States, 45267-0501
- Charles M. Barrett Cancer Center at University Hospital
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Cleveland, Ohio, United States, 44195-9001
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, United States, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Columbus, Ohio, United States, 43206
- CCOP - Columbus
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Dayton, Ohio, United States, 45429
- CCOP - Dayton
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Dayton, Ohio, United States, 45428-1002
- Veterans Affairs Medical Center - Dayton
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Toledo, Ohio, United States, 43623-3456
- CCOP - Toledo Community Hospital
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Oklahoma University Medical Center
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Oregon
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Portland, Oregon, United States, 97207
- Veterans Affairs Medical Center - Portland
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Portland, Oregon, United States, 97225
- CCOP - Columbia River Oncology Program
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Portland, Oregon, United States, 97201-3098
- Cancer Institute at Oregon Health and Science University
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South Carolina
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Charleston, South Carolina, United States, 29425
- Hollings Cancer Center at Medical University of South Carolina
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Charleston, South Carolina, United States, 29401-5799
- Veterans Affairs Medical Center - Charleston
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Greenville, South Carolina, United States, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, United States, 29303
- CCOP - Upstate Carolina
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Tennessee
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Memphis, Tennessee, United States, 38104
- University of Tennessee Cancer Institute
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Memphis, Tennessee, United States, 38104
- Danville Radiation Therapy Center
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Texas
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Amarillo, Texas, United States, 79106
- Harrington Cancer Center
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Amarillo, Texas, United States, 79106
- Veterans Affairs Medical Center - Amarillo
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Dallas, Texas, United States, 75216
- Veterans Affairs Medical Center - Dallas
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Fort Sam Houston, Texas, United States, 78234-6200
- Brooke Army Medical Center
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Galveston, Texas, United States, 77555-0565
- University of Texas Medical Branch
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Houston, Texas, United States, 77030
- Veterans Affairs Medical Center - Houston
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Houston, Texas, United States, 77030-4095
- University of Texas - MD Anderson Cancer Center
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San Antonio, Texas, United States, 78229-3900
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, United States, 78229
- Veterans Affairs Medical Center - San Antonio (Murphy)
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Temple, Texas, United States, 76504
- Veterans Affairs Medical Center - Temple
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Temple, Texas, United States, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, United States, 84148
- Veterans Affairs Medical Center - Salt Lake City
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Salt Lake City, Utah, United States, 84112-5550
- Huntsman Cancer Institute
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Washington
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Seattle, Washington, United States, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, United States, 98108
- Veterans Affairs Medical Center - Seattle
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Seattle, Washington, United States, 98104
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
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Tacoma, Washington, United States, 98431-5000
- Madigan Army Medical Center
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Tacoma, Washington, United States, 98405-0986
- CCOP - Northwest
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: L-glutamine in suspension + radiation
20 cc three times daily for 60 days plus radiation therapy.
|
20 cc three times daily for 60 days
Other Names:
Per institutional standard; minimum of 6,000 cGy with a daily dose of 180-200 cGy.
|
Placebo Comparator: Placebo in suspension + radiation
20 cc three times daily for 60 days plus radiation therapy.
|
Per institutional standard; minimum of 6,000 cGy with a daily dose of 180-200 cGy.
20 cc three times daily for 60 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effectiveness of L-glutamine for mucositis
Time Frame: 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.
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2 weeks after end of radiation treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of severe mucositis, radiation treatment delay, and weight loss
Time Frame: 2 weeks after radiation treatment
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2 weeks after radiation treatment
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Toxicities
Time Frame: within 2 weeks after radiation treatment
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within 2 weeks after radiation treatment
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Compare patient reported mouth pain "success" rate at the end of radiation treatment
Time Frame: 2 weeks after end of radiation treatment
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2 weeks after end of radiation treatment
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Compliance (dose taken) in patients treated with L-glutamine when given with radiation treatment
Time Frame: 2 weeks after end of radiation treatment
|
2 weeks after end of radiation treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: V. S. Klimberg, MD, University of Arkansas
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage III squamous cell carcinoma of the lip and oral cavity
- stage IV squamous cell carcinoma of the lip and oral cavity
- stage III squamous cell carcinoma of the oropharynx
- stage IV squamous cell carcinoma of the oropharynx
- 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 I squamous cell carcinoma of the oropharynx
- stage II squamous cell carcinoma of the oropharynx
- oral complications of radiation therapy
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000068353
- U10CA037429 (U.S. NIH Grant/Contract)
- S9908 (Other Identifier: SWOG)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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