Effects of Perioperative Immunonutrition in Patients With Head and Neck Cancer
NCT ID: NCT06318221
Last Updated: 2024-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
34 participants
INTERVENTIONAL
2019-05-01
2021-02-01
Brief Summary
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Five days before surgery and the postoperative day 10, immunonutrition support was given to the intervention group (n=17), and standard EN support was given to the control group (n=17). Body analyses were made, food consumption records were taken, NRS-2002 and quality of life scales were applied, and biochemical parameters were recorded.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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immunonutrition (intervention group)
Immunonutrition enteral products was given to the patients in the intervention group
Experimental (Immunonutrition) Group
Immunonutrition was given to the patients in the intervention group and ready-to-use liquid in addition to their normal nutrition 5 days before the operation. The patients were instructed to consume three enteral products per day as taken between meals.
In the postoperative period, feeding was started in the first 24 hours with the NG tube placed during the operation. The ready-to-use immunonutrition product was given to the patients in the intervention group.
standard (control group)
Standard enteral products was given to patients in the control group.
Active Comparator Group ( Standard enteral nutrition)
Standard enteral nutrition was given to patients in the control group in addition to their normal nutrition 5 days before the operation. The patients were instructed to consume three enteral products per day between meals.
In the postoperative period, feeding was started in the first 24 hours with the NG tube placed during the operation. Liquid standard enteral nutrition was given to the patients in the control group.
Interventions
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Experimental (Immunonutrition) Group
Immunonutrition was given to the patients in the intervention group and ready-to-use liquid in addition to their normal nutrition 5 days before the operation. The patients were instructed to consume three enteral products per day as taken between meals.
In the postoperative period, feeding was started in the first 24 hours with the NG tube placed during the operation. The ready-to-use immunonutrition product was given to the patients in the intervention group.
Active Comparator Group ( Standard enteral nutrition)
Standard enteral nutrition was given to patients in the control group in addition to their normal nutrition 5 days before the operation. The patients were instructed to consume three enteral products per day between meals.
In the postoperative period, feeding was started in the first 24 hours with the NG tube placed during the operation. Liquid standard enteral nutrition was given to the patients in the control group.
Eligibility Criteria
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Inclusion Criteria
* who agree to receive standard EN or immunonutrition before surgery,
* those between the ages of 18-75,
* those with normal hematopoietic (absolute neutrophil count \>1.8x109/L, hemoglobin level ≥9 g/dL) hepatic and renal function
Exclusion Criteria
* Received EN support before the study
* have an active infection, any autoimmune, renal or hepatic disease, malabsorption, type 1 diabetes or mental illness
* taking vitamin-mineral supplements and immunosuppressive treatment,
* Morbidly obese (BMI ≥40 kg/m2), HIV positive, pregnant and breastfeeding individuals
18 Years
75 Years
ALL
Yes
Sponsors
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TC Erciyes University
OTHER
Responsible Party
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Eda Başmısırlı
Asst. Prof. Dr.
Locations
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Erciyes University
Talas, Kayseri, Turkey (Türkiye)
Countries
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Other Identifiers
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06156930
Identifier Type: -
Identifier Source: org_study_id
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