Effects of Perioperative Immunonutrition in Patients With Head and Neck Cancer

NCT06318221 | Completed DMC

• 1 other identifier: 06156930
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Nutrition, Healthy

Keywords

head and neck cancer; immunonutrition; enteral nutrition; Perioperative nutrition; Nutritional counseling

Outcome Measures

Primary Outcomes (10)

• 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)

  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.

  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 Outcomes (2)

• Length of hospital stay

  40 days

• Complication development status

  40 days

Study Arms (2)

immunonutrition (intervention group)

EXPERIMENTAL

Immunonutrition enteral products was given to the patients in the intervention group

Dietary Supplement: Experimental (Immunonutrition) Group

standard (control group)

ACTIVE COMPARATOR

Standard enteral products was given to patients in the control group.

Dietary Supplement: Active Comparator Group ( Standard enteral nutrition)

Interventions

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.

immunonutrition (intervention group)

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.

standard (control group)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Talas, Kayseri, 38280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Immunonutrition Diet; Population Groups

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Dr.

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: March 19, 2024
• Study Start: May 1, 2019
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)