Effects of Perioperative Immunonutrition in Patients With Head and Neck Cancer

A Randomized Clinical Trial With Perioperative Immunonutrition Support on Anthropometric, Clinical and Biochemical Parameters of Head and Neck Cancer Patients Undergoing Surgery

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Nutrition, Healthy
• Intervention / Treatment: Dietary supplement: Experimental (Immunonutrition) Group; Dietary supplement: Active Comparator Group ( Standard enteral nutrition)

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kayseri
    • Talas, Kayseri, Turkey, 38280
      • Erciyes University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: immunonutrition (intervention group); Immunonutrition enteral products was given to the patients in the intervention group	Dietary supplement: 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: standard (control group); Standard enteral products was given to patients in the control group.	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)	Estimate the average of the items that contribute to the scale; this is the raw score.; 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.	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
Albumin	g/dL	40 days
C-reactive protein	mg/L	40 days
Prealbumin	mg/dL	40 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	days	40 days
Complication development status	It was evaluated as yes/no.	40 days

Collaborators and Investigators

• Sponsor: TC Erciyes University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: head and neck cancer; immunonutrition; enteral nutrition; Nutritional counseling; Perioperative nutrition
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 06156930

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No