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'Aurelle

Status and phase: Completed; Phase 2

Conditions: Head and Neck Cancer

Treatments: Drug: cisplatin; Procedure: adjuvant therapy; Radiation: radiation therapy; Dietary Supplement: arginine/omega-3 fatty acids/nucleotides oral supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT00559156

CLCC-IMPACT-RT

CDR0000574125

INCA-RECF0286

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

46 participants in 1 patient group

Oral Impact

Experimental group

Description:

Oral Impact Supplement: 3 bags/day, 5 days before each chemotherapy

Treatment:

Dietary Supplement: arginine/omega-3 fatty acids/nucleotides oral supplement

Radiation: radiation therapy

Procedure: adjuvant therapy

Drug: cisplatin