Clinical trial NCT02622880: Comparison of Two Immunomodulatory Formulas on the Number of Postoperative Infections in Head & Neck Cancer Patients
Official title: Comparison of Two Immunomodulatory Formulas on the Number of Postoperative Infections in Oropharyngeal and Maxillofacial Cancer Patients Eligible Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Head and Neck Neoplasms
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: Vegenat, S.A.
First posted: 2015-12-07
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Number of postoperative infections
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Change from baseline Retinol-binding protein
timeFrame: 0 and 30 days
measure: Length of post-operative hospital stay
timeFrame: through study completion, an average of 3 months
measure: Mortality
timeFrame: through study completion, an average of 3 months
measure: change from baseline C-reactive protein
timeFrame: 0 and 30 days
measure: change from baseline albumin
timeFrame: 0 and 30 days
measure: change from baseline transferrin
timeFrame: 0 and 30 days
measure: change from baseline prealbumin
timeFrame: 0 and 30 days
measure: change from baseline Bioelectrical impedance analysis
timeFrame: 0 and 30 days
measure: change from baseline leukocytes
timeFrame: 0 and 30 days
measure: change from baseline Fibrinogen
timeFrame: 0 and 30 days
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitairo La Paz
Study officials:
affiliation: Hospital Universitario La Paz
name: Carmen Gomez Candela
role: PRINCIPAL_INVESTIGATOR
References: