Back to resultsComparison of Two Immunomodulatory Formulas on the Number of Postoperative Infections in Head & Neck Cancer Patients
Primary Purpose
Head and Neck Neoplasms
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
immunomodulatory supplement
IMPACT
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Neoplasms
Eligibility Criteria
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.
Sites / Locations
- Hospital Universitairo La Paz
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
: IMPACT
immunomodulatory supplement
Arm Description
along 10 days before surgery
along 10 days before surgery
Outcomes
Primary Outcome Measures
Number of postoperative infections
Secondary Outcome Measures
Change from baseline Retinol-binding protein
Length of post-operative hospital stay
Mortality
change from baseline C-reactive protein
change from baseline albumin
change from baseline transferrin
change from baseline prealbumin
change from baseline Bioelectrical impedance analysis
change from baseline leukocytes
change from baseline Fibrinogen
Full Information
NCT ID
NCT02622880
First Posted
November 24, 2015
Last Updated
December 2, 2015
Sponsor
Instituto de Investigación Hospital Universitario La Paz
Collaborators
Vegenat, S.A.
1. Study Identification
Unique Protocol Identification Number
NCT02622880
Brief Title
Comparison of Two Immunomodulatory Formulas on the Number of Postoperative Infections in Head & Neck Cancer Patients
Official Title
Comparison of Two Immunomodulatory Formulas on the Number of Postoperative Infections in Oropharyngeal and Maxillofacial Cancer Patients Eligible Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Hospital Universitario La Paz
Collaborators
Vegenat, S.A.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
: IMPACT
Arm Type
Active Comparator
Arm Description
along 10 days before surgery
Arm Title
immunomodulatory supplement
Arm Type
Experimental
Arm Description
along 10 days before surgery
Intervention Type
Dietary Supplement
Intervention Name(s)
immunomodulatory supplement
Intervention Description
Experimental Group (immunomodulatory supplement STUDY)
Intervention Type
Dietary Supplement
Intervention Name(s)
IMPACT
Intervention Description
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 Outcome Measure Information:
Title
Number of postoperative infections
Time Frame
30 days after surgery
Secondary Outcome Measure Information:
Title
Change from baseline Retinol-binding protein
Time Frame
0 and 30 days
Title
Length of post-operative hospital stay
Time Frame
through study completion, an average of 3 months
Title
Mortality
Time Frame
through study completion, an average of 3 months
Title
change from baseline C-reactive protein
Time Frame
0 and 30 days
Title
change from baseline albumin
Time Frame
0 and 30 days
Title
change from baseline transferrin
Time Frame
0 and 30 days
Title
change from baseline prealbumin
Time Frame
0 and 30 days
Title
change from baseline Bioelectrical impedance analysis
Time Frame
0 and 30 days
Title
change from baseline leukocytes
Time Frame
0 and 30 days
Title
change from baseline Fibrinogen
Time Frame
0 and 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Gomez Candela
Organizational Affiliation
Hospital Universitario La Paz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitairo La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
12. IPD Sharing Statement
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Comparison of Two Immunomodulatory Formulas on the Number of Postoperative Infections in Head & Neck Cancer Patients
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