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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cancer-related Problem/Condition, Head and Neck Cancer, Pain

Intervention / Treatment
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* Dietary Supplement: glutamine
* Radiation: radiation therapy
* Drug: l-glutamine placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: L-glutamine in suspension + radiation<br>20 cc three times daily for 60 days plus radiation therapy. | Dietary Supplement: glutamine<br>* 20 cc three times daily for 60 days<br>* Other names: NSC-143503;Radiation: radiation therapy<br>* Per institutional standard; minimum of 6,000 cGy with a daily dose of 180-200 cGy.<br>|
| Placebo Comparator: Placebo in suspension + radiation<br>20 cc three times daily for 60 days plus radiation therapy. | Radiation: radiation therapy<br>* Per institutional standard; minimum of 6,000 cGy with a daily dose of 180-200 cGy.<br>Drug: l-glutamine placebo<br>* 20 cc three times daily for 60 days<br>* Other names: NSC-143503;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of L-glutamine for mucositis | 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. | 2 weeks after end of radiation treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, oral complications of radiation therapy, 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