Arginine/Omega-3 Fatty Acids/Nucleotides Nutritional Supplement in Treating Patients With Stage III or Stage IV Head and Neck Cancer Undergoing Chemotherapy and Radiation Therapy

OBJECTIVES:

• Assess the effects of immunomodulator arginine/omega-3 fatty acids/nucleotides oral supplement (Oral IMPACT®) administered via percutaneous gastrostomy during adjuvant chemoradiotherapy in patients with stage III or IV epidermoid head and neck cancer.

OUTLINE: This is a multicenter study.

Patients undergo radiotherapy 5 days a week for 6½ weeks. Patients receive cisplatin IV during weeks 1, 4, and 7 of radiotherapy. Patients also receive arginine/omega-3 fatty acids/nucleotides oral supplement (Oral IMPACT®) via percutaneous gastrostomy tube 3 times daily for 5 days before each chemotherapy treatment.

DISEASE CHARACTERISTICS:

• Diagnosis of head and neck cancer meeting the following criteria:

• Epidermoid carcinoma
• Stage III or IV disease
• Must have percutaneous gastrostomy tube in place
• Must have undergone prior surgery for head and neck cancer within the past 6-8 weeks
• No cerebral metastases

PATIENT CHARACTERISTICS:

• WHO performance status (PS) 0-2 OR Karnofsky PS 60-100%
• Life expectancy > 3 months
• WBC > 4,000/mm³
• ANC > 2,000/mm³
• Platelet count > 100,000/mm³
• PTT ≥ 50%
• Creatinine < 130 μmol/L
• Not pregnant or nursing
• Fertile patients must use effective contraception
• No severe sepsis
• No requirement for parenteral nutrition
• No pre-existing digestive pathology that results in bowel obstruction, nausea, vomiting, and/or abdominal pain > grade 1

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics