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

Closed

Phase

Accrual

13%

Abbreviated Title

Glutamine for Oral Mucositis

Activated

11/01/2001

Closed

04/15/2005

Participants

NCORP, Members, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists

Research committees

Head and Neck Cancer

Treatment

Radiation Therapy Surgery L-Glutamine (in AES0014 Delivery Vehicle)

Eligibility Criteria Expand/Collapse

Pt must have a new dx, previously untreated, squamous cell cancer of the oral cavity or oropharynx (T1-T4, N0, M0). Pt must be scheduled to receive high dose XRT of at least 6,000 cGy w/a daily dose of 180-200 cGy. IMRT may be substituted for XRT. XRT must be planned to begin 7-28 days after registration. Pt must not be currently or planning to receive tx on any other SWOG protocol. Pt must not be planning to receive any concomitant chemo w/agents other than cisplatin, carboplatin or F-FU while on protocol tx. Pt must not have received any chemo prior to reg. Pt must not be planning to receive concomitant amifostine during XRT or for 2 wks following XRT. Pt must have a Zubrod PS of 0-2. Pt must complete prestudy Brief Pain Inventory w/in 28 days prior to registration.

CANCER CONTROL CREDIT: 0.5

Publication Information Expand/Collapse

2003

Report from the Radiation Oncology Committee of the Southwest Oncology Group (SWOG): Research Objectives Workshop 2003 PMID14528084

P Okunieff;RE Meyn;BA Teicher;CR Thomas, Jr.;LE Gaspar;D Raben;S Giri;RS Lavey;AT Turrisi;GP Swanson;SR Smalley American Journal of Clinical Oncology 26(5):522-529

PMid: PMID14528084