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Role of Peri-operative Immunonutrition in Cancers of the Higher Aero-digestive Tract
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.
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Centre Antoine Lacassagne
Nice, France
Start Date
July 1, 2007
Primary Completion Date
July 1, 2009
Completion Date
April 1, 2011
Last Updated
September 30, 2025
311
ACTUAL participants
therapeutic nutritional supplementation
DIETARY_SUPPLEMENT
placebo
OTHER
Lead Sponsor
Centre Antoine Lacassagne
NCT06650501
NCT06237452
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