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

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.

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