Trial Information

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

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.