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

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: Completed
• Conditions: Head and Neck Neoplasms
• Intervention / Treatment: Dietary supplement: IMPACT; Dietary supplement: immunomodulatory supplement

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: Interventional
• Enrollment (Actual): 68
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Number of postoperative infections	30 days after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline Retinol-binding protein	0 and 30 days
Length of post-operative hospital stay	through study completion, an average of 3 months
Mortality	through study completion, an average of 3 months
change from baseline C-reactive protein	0 and 30 days
change from baseline albumin	0 and 30 days
change from baseline transferrin	0 and 30 days
change from baseline prealbumin	0 and 30 days
change from baseline Bioelectrical impedance analysis	0 and 30 days
change from baseline leukocytes	0 and 30 days
change from baseline Fibrinogen	0 and 30 days

Collaborators and Investigators

• Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Collaborators: Vegenat, S.A.
• Investigators: Principal Investigator: Carmen Gomez Candela, Hospital Universitario La Paz

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: November 24, 2015
• First Submitted That Met QC Criteria: December 2, 2015
• First Posted (Estimate): December 7, 2015

Study Record Updates

• Last Update Posted (Estimate): December 7, 2015
• Last Update Submitted That Met QC Criteria: December 2, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: VEGENAT