Effects of Perioperative Immunonutrition in Patients With Head and Neck Cancer

Not Applicable

Completed

• Conditions: Head and Neck Cancer; Nutrition, Healthy
• Interventions: Dietary Supplement: Active Comparator Group ( Standard enteral nutrition); Dietary Supplement: Experimental (Immunonutrition) Group

• Registration Number: NCT06318221
• Lead Sponsor: TC Erciyes University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-01
• Primary Completion: 2021-02-01
• Study Completion: 2021-02-01
• Study First Submitted: 2024-02-15
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-12
• Last Update Submitted: 2024-03-12
• Study First Posted: 2024-03-19
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard (control group)	Active Comparator Group ( Standard enteral nutrition)	Standard enteral products was given to patients in the control group.
immunonutrition (intervention group)	Experimental (Immunonutrition) Group	Immunonutrition enteral products was given to the patients in the intervention group

Primary Outcome Measures

Name	Time	Method
Albumin	40 days	g/dL
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).
C-reactive protein	40 days	mg/L
Prealbumin	40 days	mg/dL

Secondary Outcome Measures

Name	Time	Method
Complication development status	40 days	It was evaluated as yes/no.
Length of hospital stay	40 days	days

Trial Locations

Locations (1)

Erciyes University; 🇹🇷 Talas, Kayseri, Turkey