Head and Neck Neoplasms
Conditions
Brief summary
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
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).
Interventions
DIETARY_SUPPLEMENTimmunomodulatory supplement
Experimental Group (immunomodulatory supplement STUDY)
DIETARY_SUPPLEMENTIMPACT
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.
Sponsors
Vegenat, S.A.
Instituto de Investigación Hospital Universitario La Paz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of postoperative infections | 30 days after surgery |
Secondary
| Measure | Time frame |
|---|---|
| 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 Retinol-binding protein | 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 |
| change from baseline transferrin | 0 and 30 days |
Countries
Spain
Outcome results
None listed