The purpose of this study is to evaluate the effect of an immune formula , consumed 10 days before surgery , on the number and characteristics of postoperative infections for a period of 30 days in a group of oropharynx, hypopharynx , larynx and oral cavity squamous cell cancer patients, candidates for surgery.
68 subjects randomized into two study groups: 34 subjects consume the supplement of the study and 34 control consume the supplement IMPACT. Intervention period will be 10 days before surgery . The consume amount is 400 ml/ day. The Subjects were stratified according to tumor location ( larynx and oral cavity and oropharynx, hypopharynx) and disease stage (early and advanced).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
68
Experimental Group (immunomodulatory supplement STUDY)
IMPACT (Nestle Healthcare Nutrition, Minnesota USA) an 'immune-enhancing' feed which contains supplemental L-arginine (1.25 78 g/L), dietary nucleotides (1.2 g/L) and omega-3 fatty acids in the form of 79 eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (EPA/DHA 1.7 g/L) 80 as its active ingredients.
Hospital Universitairo La Paz
Madrid, Madrid, Spain
Number of postoperative infections
Time frame: 30 days after surgery
Change from baseline Retinol-binding protein
Time frame: 0 and 30 days
Length of post-operative hospital stay
Time frame: through study completion, an average of 3 months
Mortality
Time frame: through study completion, an average of 3 months
change from baseline C-reactive protein
Time frame: 0 and 30 days
change from baseline albumin
Time frame: 0 and 30 days
change from baseline transferrin
Time frame: 0 and 30 days
change from baseline prealbumin
Time frame: 0 and 30 days
change from baseline Bioelectrical impedance analysis
Time frame: 0 and 30 days
change from baseline leukocytes
Time frame: 0 and 30 days
change from baseline Fibrinogen
Time frame: 0 and 30 days
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