Role of Peri-operative Immunonutrition in Cancers of the Higher Aero-digestive Tract
- Determine the efficacy of immunonutrition (IMPACT®) in patients with de novo cancer of
the upper aerodigestive tract.
- 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
- 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.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Rate of infectious complication
Marie-Noelle Falewee Pastor
Centre Antoine Lacassagne