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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Giving a nutritional supplement containing arginine, omega-3 fatty acids, and nucleotides to patients undergoing chemotherapy and radiation therapy may stimulate the immune system and help the body build a stronger immune response.

PURPOSE: This phase II trial is studying how well an arginine/omega-3 fatty acids/nucleotides nutritional supplement works in treating patients with stage III or stage IV head and neck cancer undergoing chemotherapy and radiation therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

Criteria

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