Comparison of Two Immunomodulatory Formulas on the Number of Postoperative Infections in Head & Neck Cancer Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Comparison of Two Immunomodulatory Formulas on the Number of Postoperative Infections in Oropharyngeal and Maxillofacial Cancer Patients Eligible Surgery

Conditions
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Head and Neck Neoplasms

Intervention / Treatment
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* Dietary Supplement: immunomodulatory supplement
* Dietary Supplement: IMPACT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women >18 years Patients with histologically confirmed squamous cell cancer of the oropharynx, hypopharynx , larynx and oral cavity and candidates for neoplastic surgery (undergoing surgery) Adequate cultural level and understanding for the clinical trial. and agree to participate voluntarily in the study and give written informed consent Patients who do not participate in other clinical trials Exclusion Criteria: Patients with an active infectious process at the time of the study. Patients who have undergone radiotherapy / chemotherapy prior to surgery. Subjects diagnosed with Type I Diabetes Mellitus Subjects who used oral hypoglycemic agents or insulin. Patients with severe kidney disease, heart, respiratory or liver. Patients with autoimmune diseases or immunosuppressive drugs used. Subjects with dementia, mental illness or diminished cognitive function. Subjects who refuse oral supplements. Subjects who consume vitamin supplements or artificial nutrition, and which can not be suspended at least 1 week before the study and do not accept to suspend it during the study. Subjects with morbid obesity (BMI ≥ 40 kg / m2). Pregnant or breastfeeding Patients diagnosed with epidermoid carcinoma T1 glottic, cordectomy candidate.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: : IMPACT<br>along 10 days before surgery | Dietary Supplement: IMPACT<br>* 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.<br>|
| Experimental: immunomodulatory supplement<br>along 10 days before surgery | Dietary Supplement: immunomodulatory supplement<br>* Experimental Group (immunomodulatory supplement STUDY)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of postoperative infections |  | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Retinol-binding protein |  | 0 and 30 days | 
| Length of post-operative hospital stay |  | through study completion, an average of 3 months | 
| Mortality |  | through study completion, an average of 3 months | 
| change from baseline C-reactive protein |  | 0 and 30 days | 
| change from baseline albumin |  | 0 and 30 days | 
| change from baseline transferrin |  | 0 and 30 days | 
| change from baseline prealbumin |  | 0 and 30 days | 
| change from baseline Bioelectrical impedance analysis |  | 0 and 30 days | 
| change from baseline leukocytes |  | 0 and 30 days | 
| change from baseline Fibrinogen |  | 0 and 30 days |