Effects of Perioperative Immunonutrition in Patients With Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06318221
• Other study ID #: 06156930
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: February 1, 2021

Study information

• Verified date: March 2024
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

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 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.

Locations

Country	Name	City	State
Turkey	Erciyes University	Talas	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	Kg	40 days
Primary	Body weight loss	Kg	40 days
Primary	Body mass index	kg/m2	40 days
Primary	Resting metabolic rate	kcal	40 days
Primary	Nutrition Risk Screening 2002	A total score of =3 indicates that the patient is at nutritional risk	40 days
Primary	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
Primary	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
Primary	Albumin	g/dL	40 days
Primary	C-reactive protein	mg/L	40 days
Primary	Prealbumin	mg/dL	40 days
Secondary	Length of hospital stay	days	40 days
Secondary	Complication development status	It was evaluated as yes/no.	40 days