Head and Neck Cancer Clinical Trial
Official title:
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
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