Overview

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

Status:
Terminated
Trial end date:
2006-04-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Southwest Oncology Group
Collaborator:
National Cancer Institute (NCI)
Criteria
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