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Completed

NCT Number: NCT02622880

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitairo La Paz

Madrid, 28046, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

immunomodulatory supplement

Dietary Supplement

Experimental Group (immunomodulatory supplement STUDY)

IMPACT

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.

Primary outcomes

  1. Number of postoperative infections

    Time frame: 30 days after surgery

Secondary outcomes

  1. Change from baseline Retinol-binding protein

    Time frame: 0 and 30 days

  2. Length of post-operative hospital stay

    Time frame: through study completion, an average of 3 months

  3. Mortality

    Time frame: through study completion, an average of 3 months

  4. change from baseline C-reactive protein

    Time frame: 0 and 30 days

  5. change from baseline albumin

    Time frame: 0 and 30 days

  6. change from baseline transferrin

    Time frame: 0 and 30 days

  7. change from baseline prealbumin

    Time frame: 0 and 30 days

  8. change from baseline Bioelectrical impedance analysis

    Time frame: 0 and 30 days

  9. change from baseline leukocytes

    Time frame: 0 and 30 days

  10. change from baseline Fibrinogen

    Time frame: 0 and 30 days

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz

Other

Collaborators

  • Vegenat, S.A.

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Dec 7, 2015
Registry last updated
Dec 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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