Glutamine in Treating Mucositis Caused by Radiation Therapy in Patients With Newly Diagnosed Cancer of the Mouth or Throat
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.
Head and Neck Cancer
Dietary Supplement: glutamine
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
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:||November 2001|
|Study Completion Date:||April 2006|
|Primary Completion Date:||April 2005 (Final data collection date for primary outcome measure)|
- 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.