Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-26 @ 12:55 AM
Study NCT ID:
NCT00006994
Status:
TERMINATED
Last Update Posted:
2015-11-18
First Post:
2000-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S9908: Glutamine in Treating Mucositis Caused by Radiation Therapy in Patients With Newly Diagnosed Cancer of the Mouth or Throat
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005973', 'term': 'Glutamine'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D021542', 'term': 'Amino Acids, Neutral'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'whyStopped': 'Withdrawn due to drug availability and funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2001-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-17', 'studyFirstSubmitDate': '2000-12-06', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2015-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of L-glutamine for mucositis', 'timeFrame': '2 weeks after end of radiation treatment', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Duration of severe mucositis, radiation treatment delay, and weight loss', 'timeFrame': '2 weeks after radiation treatment'}, {'measure': 'Toxicities', 'timeFrame': 'within 2 weeks after radiation treatment'}, {'measure': 'Compare patient reported mouth pain "success" rate at the end of radiation treatment', 'timeFrame': '2 weeks after end of radiation treatment'}, {'measure': 'Compliance (dose taken) in patients treated with L-glutamine when given with radiation treatment', 'timeFrame': '2 weeks after end of radiation treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['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'], 'conditions': ['Cancer-related Problem/Condition', 'Head and Neck Cancer', 'Pain']}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: 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.', 'detailedDescription': 'OBJECTIVES:\n\n* 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.\n* Compare the duration of severe mucositis in patients treated with these regimens.\n* Compare the radiotherapy delay in patients treated with these regimens.\n* Compare weight loss in patients treated with these regimens.\n* Compare the toxic effects of these two regimens in these patients.\n* Compare patient-reported mouth pain success rate in patients treated with these regimens.\n* Determine the compliance of patients treated with this drug regimen.\n\nOUTLINE: 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.\n\n* 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.\n* 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.\n\nPatients are followed for 2 weeks.\n\nPROJECTED ACCRUAL: A total of 158 patients (79 per treatment arm) will be accrued for this study within 2.5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Newly diagnosed, previously untreated squamous cell cancer of the oral cavity or oropharynx (T1-T4, any N, M0)\n* Must be scheduled to receive high-dose radiotherapy\n* Not concurrently receiving or planning to receive treatment on any other Southwest Oncology Group protocol\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 to 90\n\nPerformance status:\n\n* Zubrod 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* Not specified\n\nOther:\n\n* 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\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* No prior chemotherapy\n* Concurrent cisplatin, carboplatin, or fluorouracil allowed\n* No other concurrent chemotherapy during study and for at least 3 weeks after study radiotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* See Disease Characteristics\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* No concurrent amifostine during and for 2 weeks after study radiotherapy'}, 'identificationModule': {'nctId': 'NCT00006994', 'briefTitle': 'S9908: Glutamine in Treating Mucositis Caused by Radiation Therapy in Patients With Newly Diagnosed Cancer of the Mouth or Throat', 'organization': {'class': 'NETWORK', 'fullName': 'SWOG Cancer Research Network'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CDR0000068353'}, 'secondaryIdInfos': [{'id': 'S9908', 'type': 'OTHER', 'domain': 'SWOG'}, {'id': 'U10CA037429', 'link': 'https://reporter.nih.gov/quickSearch/U10CA037429', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'L-glutamine in suspension + radiation', 'description': '20 cc three times daily for 60 days plus radiation therapy.', 'interventionNames': ['Dietary Supplement: glutamine', 'Radiation: radiation therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo in suspension + radiation', 'description': '20 cc three times daily for 60 days plus radiation therapy.', 'interventionNames': ['Radiation: radiation therapy', 'Drug: l-glutamine placebo']}], 'interventions': [{'name': 'glutamine', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['l-glutamine', 'NSC-143503'], 'description': '20 cc three times daily for 60 days', 'armGroupLabels': ['L-glutamine in suspension + radiation']}, {'name': 'radiation therapy', 'type': 'RADIATION', 'description': 'Per institutional standard; minimum of 6,000 cGy with a daily dose of 180-200 cGy.', 'armGroupLabels': ['L-glutamine in suspension + radiation', 'Placebo in suspension + radiation']}, {'name': 'l-glutamine placebo', 'type': 'DRUG', 'otherNames': ['NSC-143503'], 'description': '20 cc three times daily for 60 days', 'armGroupLabels': ['Placebo in suspension + radiation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36607', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'MBCCOP - Gulf Coast', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85006-2726', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'CCOP - Western Regional, Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85723', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Cancer Center at University of Arizona Health Sciences Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Cancer Research Center at University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Little Rock (McClellan)', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '91010-3000', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Comprehensive Cancer Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90822', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - 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