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S9908: Glutamine in Treating Mucositis Caused by Radiation Therapy in Patients With Newly Diagnosed Cancer of the Mouth or Throat

Sponsor
Southwest Oncology Group (Other)
Overall Status
Terminated
CT.gov ID
NCT00006994
Collaborator
National Cancer Institute (NCI) (NIH)
23
Enrollment
107
Locations
2
Arms
53
Duration (Months)
0.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: glutamine
  • Radiation: radiation therapy
  • Drug: l-glutamine placebo
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Supportive Care
Official Title:
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
Study Start Date :
Nov 1, 2001
Actual Primary Completion Date :
Apr 1, 2005
Actual Study Completion Date :
Apr 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: L-glutamine in suspension + radiation

20 cc three times daily for 60 days plus radiation therapy.

Dietary Supplement: glutamine
20 cc three times daily for 60 days
Other Names:
  • l-glutamine
  • NSC-143503

    • Radiation: radiation therapy
    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.

    Radiation: radiation therapy
    Per institutional standard; minimum of 6,000 cGy with a daily dose of 180-200 cGy.

    Drug: l-glutamine placebo
    20 cc three times daily for 60 days
    Other Names:
  • NSC-143503

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Duration of severe mucositis, radiation treatment delay, and weight loss [2 weeks after radiation treatment]

    2. Toxicities [within 2 weeks after radiation treatment]

    3. Compare patient reported mouth pain "success" rate at the end of radiation treatment [2 weeks after end of radiation treatment]

    4. Compliance (dose taken) in patients treated with L-glutamine when given with radiation treatment [2 weeks after end of radiation treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MBCCOP - Gulf Coast Mobile Alabama United States 36607
    2 CCOP - Western Regional, Arizona Phoenix Arizona United States 85006-2726
    3 Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) Phoenix Arizona United States 85012
    4 Veterans Affairs Medical Center - Tucson Tucson Arizona United States 85723
    5 Arizona Cancer Center at University of Arizona Health Sciences Center Tucson Arizona United States 85724
    6 Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    7 Veterans Affairs Medical Center - Little Rock (McClellan) Little Rock Arkansas United States 72205
    8 City of Hope Comprehensive Cancer Center Duarte California United States 91010-3000
    9 Veterans Affairs Medical Center - Long Beach Long Beach California United States 90822
    10 USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California United States 90033
    11 Veterans Affairs Medical Center - West Los Angeles Los Angeles California United States 90073
    12 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781
    13 Veterans Affairs Outpatient Clinic - Martinez Martinez California United States 94553
    14 CCOP - Bay Area Tumor Institute Oakland California United States 94609-3305
    15 Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center Orange California United States 92868
    16 University of California Davis Cancer Center Sacramento California United States 95817
    17 UCSF Comprehensive Cancer Center San Francisco California United States 94143-0128
    18 CCOP - Santa Rosa Memorial Hospital Santa Rosa California United States 95403
    19 David Grant Medical Center Travis Air Force Base California United States 94535
    20 University of Colorado Cancer Center at University of Colorado Health Sciences Center Aurora Colorado United States 80010
    21 Veterans Affairs Medical Center - Denver Denver Colorado United States 80220
    22 MBCCOP - Howard University Cancer Center Washington District of Columbia United States 20060
    23 Veterans Affairs Medical Center - Tampa (Haley) Tampa Florida United States 33612
    24 CCOP - Atlanta Regional Atlanta Georgia United States 30342-1701
    25 Dwight David Eisenhower Army Medical Center Fort Gordon Georgia United States 30905-5650
    26 MBCCOP - Hawaii Honolulu Hawaii United States 96813
    27 Tripler Army Medical Center Honolulu Hawaii United States 96859-5000
    28 MBCCOP - University of Illinois at Chicago Chicago Illinois United States 60612
    29 Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago Illinois United States 60612
    30 CCOP - Central Illinois Decatur Illinois United States 62526
    31 Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) Hines Illinois United States 60141
    32 Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood Illinois United States 60153-5500
    33 Genesis Regional Cancer Center at Genesis Medical Center Davenport Iowa United States 52804
    34 Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Kansas City Kansas United States 66160-7353
    35 CCOP - Wichita Wichita Kansas United States 67214-3882
    36 Veterans Affairs Medical Center - Wichita Wichita Kansas United States 67218
    37 Veterans Affairs Medical Center - Lexington Lexington Kentucky United States 40502-2236
    38 Markey Cancer Center at University of Kentucky Chandler Medical Center Lexington Kentucky United States 40536-0084
    39 MBCCOP - LSU Health Sciences Center New Orleans Louisiana United States 70112
    40 Tulane Cancer Center at Tulane University Hospital and Clinic New Orleans Louisiana United States 70112
    41 Veterans Affairs Medical Center - New Orleans New Orleans Louisiana United States 70112
    42 Veterans Affairs Medical Center - Shreveport Shreveport Louisiana United States 71101-4295
    43 Louisiana State University Health Sciences Center - Shreveport Shreveport Louisiana United States 71130-3932
    44 Cancer Research Center at Boston Medical Center Boston Massachusetts United States 02118
    45 Veterans Affairs Medical Center - Ann Arbor Ann Arbor Michigan United States 48105
    46 CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan United States 48106
    47 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109-0912
    48 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201-1379
    49 Veterans Affairs Medical Center - Detroit Detroit Michigan United States 48201-1932
    50 Josephine Ford Cancer Center at Henry Ford Hospital Detroit Michigan United States 48202
    51 CCOP - Grand Rapids Grand Rapids Michigan United States 49503
    52 CCOP - Beaumont Royal Oak Michigan United States 48073-6769
    53 Providence Cancer Institute at Providence Hospital Southfield Michigan United States 48075
    54 CCOP - Duluth Duluth Minnesota United States 55805
    55 University of Mississippi Medical Center Jackson Mississippi United States 39216-4505
    56 Veterans Affairs Medical Center - Jackson Jackson Mississippi United States 39216
    57 Keesler Medical Center - Keesler Air Force Base Keesler AFB Mississippi United States 39534-2576
    58 CCOP - Kansas City Kansas City Missouri United States 64131
    59 St. Louis University Hospital Cancer Center Saint Louis Missouri United States 63110
    60 CCOP - St. Louis-Cape Girardeau Saint Louis Missouri United States 63141
    61 CCOP - Cancer Research for the Ozarks Springfield Missouri United States 65807
    62 CCOP - Montana Cancer Consortium Billings Montana United States 59101
    63 Veterans Affairs Medical Center - East Orange East Orange New Jersey United States 07018-1095
    64 Veterans Affairs Medical Center - Albuquerque Albuquerque New Mexico United States 87108-5138
    65 MBCCOP - University of New Mexico HSC Albuquerque New Mexico United States 87131
    66 NYU School of Medicine's Kaplan Comprehensive Cancer Center New York New York United States 10016
    67 Herbert Irving Comprehensive Cancer Center at Columbia University New York New York United States 10032
    68 James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester New York United States 14642
    69 Veterans Affairs Medical Center - Salisbury Salisbury North Carolina United States 28144
    70 CCOP - Southeast Cancer Control Consortium Winston-Salem North Carolina United States 27104-4241
    71 Veterans Affairs Medical Center - Cincinnati Cincinnati Ohio United States 45220-2288
    72 Charles M. Barrett Cancer Center at University Hospital Cincinnati Ohio United States 45267-0501
    73 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195-9001
    74 CCOP - Columbus Columbus Ohio United States 43206
    75 Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio United States 43210-1240
    76 Veterans Affairs Medical Center - Dayton Dayton Ohio United States 45428-1002
    77 CCOP - Dayton Dayton Ohio United States 45429
    78 CCOP - Toledo Community Hospital Toledo Ohio United States 43623-3456
    79 Oklahoma University Medical Center Oklahoma City Oklahoma United States 73104
    80 Cancer Institute at Oregon Health and Science University Portland Oregon United States 97201-3098
    81 Veterans Affairs Medical Center - Portland Portland Oregon United States 97207
    82 CCOP - Columbia River Oncology Program Portland Oregon United States 97225
    83 Veterans Affairs Medical Center - Charleston Charleston South Carolina United States 29401-5799
    84 Hollings Cancer Center at Medical University of South Carolina Charleston South Carolina United States 29425
    85 CCOP - Greenville Greenville South Carolina United States 29615
    86 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
    87 Danville Radiation Therapy Center Memphis Tennessee United States 38104
    88 University of Tennessee Cancer Institute Memphis Tennessee United States 38104
    89 Harrington Cancer Center Amarillo Texas United States 79106
    90 Veterans Affairs Medical Center - Amarillo Amarillo Texas United States 79106
    91 Veterans Affairs Medical Center - Dallas Dallas Texas United States 75216
    92 Brooke Army Medical Center Fort Sam Houston Texas United States 78234-6200
    93 University of Texas Medical Branch Galveston Texas United States 77555-0565
    94 University of Texas - MD Anderson Cancer Center Houston Texas United States 77030-4095
    95 Veterans Affairs Medical Center - Houston Houston Texas United States 77030
    96 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229-3900
    97 Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio Texas United States 78229
    98 Veterans Affairs Medical Center - Temple Temple Texas United States 76504
    99 CCOP - Scott and White Hospital Temple Texas United States 76508
    100 Huntsman Cancer Institute Salt Lake City Utah United States 84112-5550
    101 Veterans Affairs Medical Center - Salt Lake City Salt Lake City Utah United States 84148
    102 CCOP - Virginia Mason Research Center Seattle Washington United States 98101
    103 Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle Washington United States 98104
    104 Veterans Affairs Medical Center - Seattle Seattle Washington United States 98108
    105 CCOP - Northwest Tacoma Washington United States 98405-0986
    106 Madigan Army Medical Center Tacoma Washington United States 98431-5000
    107 Hospital for Sick Children Toronto Ontario Canada M5G 1X8

    Sponsors and Collaborators

    • Southwest Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: V. S. Klimberg, MD, University of Arkansas

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Southwest Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00006994
    Other Study ID Numbers:
    • CDR0000068353
    • S9908
    • U10CA037429
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Nov 18, 2015
    Last Verified:
    Nov 1, 2015
    Keywords provided by Southwest Oncology Group
    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
    Additional relevant MeSH terms:
    Head and Neck Neoplasms
    Mucositis

    Study Results

    No Results Posted as of Nov 18, 2015