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

NCT02622880 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2015-12-07

No results posted yet for this study

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.

Conditions

  • Head and Neck Neoplasms

Interventions

DIETARY_SUPPLEMENT

immunomodulatory supplement

Experimental Group (immunomodulatory supplement STUDY)

DIETARY_SUPPLEMENT

IMPACT

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 & Collaborators

  • Vegenat, S.A.

    collaborator INDUSTRY

  • Instituto de Investigación Hospital Universitario La Paz

    lead OTHER

Principal Investigators

  • Carmen Gomez Candela · Hospital Universitario La Paz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-12-31
Completion
2014-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02622880 on ClinicalTrials.gov