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Effects of Perioperative Immunonutrition in Patients With Head and Neck Cancer

T

TC Erciyes University

Status

Completed

Conditions

Nutrition, Healthy
Head and Neck Cancer

Treatments

Dietary Supplement: Experimental (Immunonutrition) Group
Dietary Supplement: Active Comparator Group ( Standard enteral nutrition)

Study type

Interventional

Funder types

Other

Identifiers

NCT06318221
06156930

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

34 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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