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

Head and Neck Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02622880
• Other study ID #: VEGENAT
• Status: Completed
• Phase: Phase 4
• First received: November 24, 2015
• Last updated: December 2, 2015
• Start date: February 2013
• Est. completion date: June 2014

Study information

• Verified date: December 2015
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

Dietary Supplement:
• immunomodulatory supplement
Experimental Group (immunomodulatory supplement STUDY)
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitairo La Paz	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz	Vegenat, S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of postoperative infections		30 days after surgery	Yes
Secondary	Change from baseline Retinol-binding protein		0 and 30 days	Yes
Secondary	Length of post-operative hospital stay		through study completion, an average of 3 months	Yes
Secondary	Mortality		through study completion, an average of 3 months	Yes
Secondary	change from baseline C-reactive protein		0 and 30 days	Yes
Secondary	change from baseline albumin		0 and 30 days	Yes
Secondary	change from baseline transferrin		0 and 30 days	Yes
Secondary	change from baseline prealbumin		0 and 30 days	Yes
Secondary	change from baseline Bioelectrical impedance analysis		0 and 30 days	Yes
Secondary	change from baseline leukocytes		0 and 30 days	Yes
Secondary	change from baseline Fibrinogen		0 and 30 days	Yes