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

NCT ID: NCT02622880

Last Updated: 2015-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-06-30

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).

Conditions

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Head and Neck Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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: IMPACT

along 10 days before surgery

Group Type ACTIVE_COMPARATOR

IMPACT

Intervention Type DIETARY_SUPPLEMENT

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.

immunomodulatory supplement

along 10 days before surgery

Group Type EXPERIMENTAL

immunomodulatory supplement

Intervention Type DIETARY_SUPPLEMENT

Experimental Group (immunomodulatory supplement STUDY)

Interventions

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immunomodulatory supplement

Experimental Group (immunomodulatory supplement STUDY)

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Investigación Hospital Universitario La Paz

OTHER

Sponsor Role lead

Vegenat, S.A.

INDUSTRY

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carmen Gomez Candela

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario La Paz

Locations

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Hospital Universitairo La Paz

Madrid, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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VEGENAT

Identifier Type: -

Identifier Source: org_study_id