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

Institut du Cancer de Montpellier - Val d'Aurelle46 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head and Neck Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes