NCT00765440

Study of Nutrition Regimens in Treating Patients With Cancer of the Upper Aerodigestive Tract

Role of Peri-operative Immunonutrition in Cancers of the Higher Aero-digestive Tract

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 311 (actual)
• Sponsor: Centre Antoine Lacassagne · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: It is not yet known which regimen of enteral nutrition is more effective in preventing infections in patients undergoing surgery for cancer of the upper aerodigestive tract. PURPOSE: This randomized phase III trial is comparing three nutrition regimens in treating patients with cancer of the upper aerodigestive tract.

Detailed description

OBJECTIVES: Primary * Determine the efficacy of immunonutrition (IMPACT®) in patients with de novo cancer of the upper aerodigestive tract. Secondary * Determine the best time to initiate treatment. * Compare the intermediate duration of treatment. * Compare nutritional parameters. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 3 treatment arms. * Arm I: Patients receive standard oral or enteral nutrition (IMPACT® placebo) over 7 days prior to surgery and over 7 days after surgery. * Arm II: Patients receive oral or enteral neoadjuvant IMPACT® nutrition over 7 days prior to surgery and enteral adjuvant standard nutrition (IMPACT® placebo) over 7 days after surgery. * Arm III: Patients receive oral or enteral IMPACT® nutrition over 7 days prior to surgery and enteral adjuvant IMPACT® nutrition over 7 days after surgery. After completion of study therapy, patients are followed at 30 days after surgery and then at 2 and 3 months.

Conditions

• Head and Neck Cancer
• Infection
• Malnutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	therapeutic nutritional supplementation	Given orally
OTHER	placebo	Given orally

Timeline

• Start date: 2007-07-01
• Primary completion: 2009-07-01
• Completion: 2011-04-01
• First posted: 2008-10-03
• Last updated: 2025-09-30

Locations

1 site across 1 country: France