Hospital Universitairo La Paz
Madrid, 28046, Spain
NCT Number: NCT02622880
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Madrid, 28046, Spain
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 30 days after surgery
Time frame: 0 and 30 days
Time frame: through study completion, an average of 3 months
Time frame: through study completion, an average of 3 months
Time frame: 0 and 30 days
Time frame: 0 and 30 days
Time frame: 0 and 30 days
Time frame: 0 and 30 days
Time frame: 0 and 30 days
Time frame: 0 and 30 days
Time frame: 0 and 30 days
Instituto de Investigación Hospital Universitario La Paz
Other
Comparison of Two Immunomodulatory Formulas on the Number of Postoperative Infections in Oropharyngeal and Maxillofacial Cancer Patients Eligible Surgery
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