Role of Peri-operative Immunonutrition in Cancers of the Higher Aero-digestive Tract
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Head and Neck Cancer
- Sponsor
- Centre Antoine Lacassagne
- Enrollment
- 311
- Locations
- 1
- Primary Endpoint
- Rate of infectious complication
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Rate of infectious complication
Time Frame: 1 year