A Phase 4 interventional study of immunomodulatory supplement and IMPACT in Head and Neck Neoplasms, sponsored by Instituto de Investigación Hospital Universitario La Paz. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-07.
Sponsored by Instituto de Investigación Hospital Universitario La Paz · Phase 4, Interventional, and Treatment
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).
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 68 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Instituto de Investigación Hospital Universitario La Paz is the lead sponsor of 100 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
along 10 days before surgery
Dietary Supplement: IMPACT
along 10 days before surgery
Dietary Supplement: immunomodulatory supplement
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.
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
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Instituto de Investigación Hospital Universitario La Paz