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

Instituto de Investigación Hospital Universitario La Paz

Status and phase

Completed

Phase 4

Conditions

Head and Neck Neoplasms

Treatments

Dietary Supplement: IMPACT

Dietary Supplement: immunomodulatory supplement

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02622880

VEGENAT

Details and patient eligibility

About

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.

Full 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).

Enrollment

68 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.