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

December 2, 2015 updated by: Instituto de Investigación Hospital Universitario La Paz

Comparison of Two Immunomodulatory Formulas on the Number of Postoperative Infections in Oropharyngeal and Maxillofacial Cancer Patients Eligible Surgery

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28046
        • Hospital Universitairo La Paz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: : IMPACT
along 10 days before surgery
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.
Experimental: immunomodulatory supplement
along 10 days before surgery
Dietary supplement: immunomodulatory supplement
Experimental Group (immunomodulatory supplement STUDY)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of postoperative infections
Time Frame: 30 days after surgery
30 days after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline Retinol-binding protein
Time Frame: 0 and 30 days
0 and 30 days
Length of post-operative hospital stay
Time Frame: through study completion, an average of 3 months
through study completion, an average of 3 months
Mortality
Time Frame: through study completion, an average of 3 months
through study completion, an average of 3 months
change from baseline C-reactive protein
Time Frame: 0 and 30 days
0 and 30 days
change from baseline albumin
Time Frame: 0 and 30 days
0 and 30 days
change from baseline transferrin
Time Frame: 0 and 30 days
0 and 30 days
change from baseline prealbumin
Time Frame: 0 and 30 days
0 and 30 days
change from baseline Bioelectrical impedance analysis
Time Frame: 0 and 30 days
0 and 30 days
change from baseline leukocytes
Time Frame: 0 and 30 days
0 and 30 days
change from baseline Fibrinogen
Time Frame: 0 and 30 days
0 and 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Instituto de Investigación Hospital Universitario La Paz

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Vegenat, S.A.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carmen Gomez Candela, Hospital Universitario La Paz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 7, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 7, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VEGENAT

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