NCT00559156

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

Phase 2 Study Assessing the Impact of Parenteral Administration of the Immunomodulater Oral IMPACT® for Postoperative Radiochemotherapy in Patients With Carcinoma of the Head and Neck

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	arginine/omega-3 fatty acids/nucleotides oral supplement
DRUG	cisplatin
PROCEDURE	adjuvant therapy
RADIATION	radiation therapy

Timeline

• Start date: 2005-06-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2007-11-16
• Last updated: 2025-02-13