Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care, Treatment Closed 18 to 90 NCI SWOG-S9908 NCI-CCC-96-23, NCI-P00-0175, S9908, NCT00006994

Objectives

1. 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.
2. Compare the duration of severe mucositis in patients treated with these regimens.
3. Compare the radiotherapy delay in patients treated with these regimens.
4. Compare weight loss in patients treated with these regimens.
5. Compare the toxic effects of these two regimens in these patients.
6. Compare patient-reported mouth pain success rate in patients treated with these regimens.
7. Determine the compliance of patients treated with this drug regimen.

Entry 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

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

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

Expected Enrollment

A total of 158 patients (79 per treatment arm) will be accrued for this study within 2.5 years.

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.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

V. Klimberg, MD, Protocol chair		Ph: 501-686-6504

Registry Information
Official Title		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
Trial Start Date		2001-11-08
Registered in ClinicalTrials.gov		NCT00006994
Date Submitted to PDQ		2000-11-02
Information Last Verified		2004-08-26
NCI Grant/Contract Number		U10-CA32102

Back to Top