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A prospective randomized controlled study compared the effects of perioperative immunonutrition and standard enteral nutrition (EN) on postoperative short-term outcomes of patients with head and neck (HNC).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| immunonutrition (intervention group) | Experimental | Immunonutrition enteral products was given to the patients in the intervention group |
|
| standard (control group) | Active Comparator | Standard enteral products was given to patients in the control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental (Immunonutrition) Group | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Kg | 40 days |
| Body weight loss | Kg | 40 days |
| Body mass index | kg/m2 | 40 days |
| Resting metabolic rate | kcal | 40 days |
| Nutrition Risk Screening 2002 | A total score of ≥3 indicates that the patient is at nutritional risk | 40 days |
| The EORTC Core Quality of Life questionnaire-30 (EORTC QLQ-C30) |
| 40 days |
| The EORTC Quality of life - Head and Neck Cancer Module (EORTC QLQ-H & N35) | The head & neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact and sexuality. There are also eleven single items. For all items and scales, high scores indicate more problems (i.e. there are no function scales in which high scores would mean better functioning). | 40 days |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | days | 40 days |
| Complication development status | It was evaluated as yes/no. | 40 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erciyes University | Talas | Kayseri | 38280 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000093702 | Immunonutrition Diet |
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Patients were classified according to tumor location (oral cavity, oropharynx, larynx or hypopharynx) and body weight loss, approximately equally in both groups. Accordingly, patients were randomly assigned (by computer) into either the immunonutrition (intervention group) or standard EN (control group) groups.
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|
| Active Comparator Group ( Standard enteral nutrition) | Dietary Supplement | 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. |
|
| Albumin |
g/dL |
| 40 days |
| C-reactive protein | mg/L | 40 days |
| Prealbumin | mg/dL | 40 days |
| D003710 | Demography |
| D011154 | Population Characteristics |