NCT02622880CompletedPhase 4
Comparison of Two Immunomodulatory Formulas on the Number of Postoperative Infections in Oropharyngeal and Maxillofacial Cancer Patients Eligible Surgery
Instituto de Investigación Hospital Universitario La Paz2 sites in 1 country68 target enrollmentStarted: February 2013Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 68
- Locations
- 2
- Primary Endpoint
- Number of postoperative infections
Study Overview
Brief 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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
: IMPACT
Active Comparator
along 10 days before surgery
Intervention: IMPACT (Dietary Supplement)
immunomodulatory supplement
Experimental
along 10 days before surgery
Intervention: immunomodulatory supplement (Dietary Supplement)
Outcomes
Primary Outcomes
Number of postoperative infections
Time Frame: 30 days after surgery
Secondary Outcomes
- Change from baseline Retinol-binding protein(0 and 30 days)
- Mortality(through study completion, an average of 3 months)
- change from baseline transferrin(0 and 30 days)
- change from baseline leukocytes(0 and 30 days)
- Length of post-operative hospital stay(through study completion, an average of 3 months)
- change from baseline Fibrinogen(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 C-reactive protein(0 and 30 days)
- change from baseline albumin(0 and 30 days)
Investigators
Study Sites (2)
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