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

NCT00559156 Phase 2 COMPLETED

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.

Details

Lead sponsor	Institut du Cancer de Montpellier - Val d'Aurelle
Phase	Phase 2
Status	COMPLETED
Enrolment	46
Start date	2005-06
Completion	2011-05

Conditions

• Head and Neck Cancer

Interventions

• arginine/omega-3 fatty acids/nucleotides oral supplement
• cisplatin
• adjuvant therapy
• radiation therapy

Primary outcomes

• Effects of immunomodulator arginine/omega-3 fatty acids/nucleotides oral supplement (Oral IMPACT®) administered via percutaneous gastrostomy during adjuvant chemoradiotherapy — 90 days after radiotherapy
  Toxicities grades 3 and 4