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| Name | Class |
|---|---|
| Vegenat, S.A. | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| : IMPACT | Active Comparator | along 10 days before surgery |
|
| immunomodulatory supplement | Experimental | along 10 days before surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immunomodulatory supplement | Dietary Supplement | Experimental Group (immunomodulatory supplement STUDY) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of postoperative infections | 30 days after surgery |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carmen Gomez Candela | Hospital Universitario La Paz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitairo La Paz | Madrid | Madrid | 28046 | Spain |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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. |
|
| 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 |