Head and Neck Cancer, Nutrition, Healthy
Conditions
Keywords
head and neck cancer, immunonutrition, enteral nutrition, Perioperative nutrition, Nutritional counseling
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTExperimental (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.
DIETARY_SUPPLEMENTActive 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.
Sponsors
TC Erciyes University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Clinical diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx who will undergo surgery, * 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
* Patients receiving neoadjuvant chemotherapy or radiotherapy to the head and neck region; * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prealbumin | 40 days | mg/dL |
| Albumin | 40 days | g/dL |
| C-reactive protein | 40 days | mg/L |
| Body weight | 40 days | Kg |
| Body weight loss | 40 days | Kg |
| Body mass index | 40 days | kg/m2 |
| Resting metabolic rate | 40 days | kcal |
| Nutrition Risk Screening 2002 | 40 days | A total score of ≥3 indicates that the patient is at nutritional risk |
| The EORTC Core Quality of Life questionnaire-30 (EORTC QLQ-C30) | 40 days | 1. Estimate the average of the items that contribute to the scale; this is the raw score. 2. Use a linear transformation to standardise the raw score, so that scores range from 0 to 100; a higher score represents a higher (better) level of functioning, or a higher (worse) level of symptoms. |
| The EORTC Quality of life - Head and Neck Cancer Module (EORTC QLQ-H & N35) | 40 days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication development status | 40 days | It was evaluated as yes/no. |
| Length of hospital stay | 40 days | days |
Countries
Turkey (Türkiye)
Outcome results
None listed