Clinical trial NCT06318221: Effects of Perioperative Immunonutrition in Patients With Head and Neck Cancer
Official title: A Randomized Clinical Trial With Perioperative Immunonutrition Support on Anthropometric, Clinical and Biochemical Parameters of Head and Neck Cancer Patients Undergoing Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Nutrition, Healthy
Keywords: head and neck cancer
immunonutrition
enteral nutrition
Perioperative nutrition
Nutritional counseling
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Body weight
timeFrame: 40 days
measure: Body weight loss
timeFrame: 40 days
measure: Body mass index
timeFrame: 40 days
measure: Resting metabolic rate
timeFrame: 40 days
measure: Nutrition Risk Screening 2002
timeFrame: 40 days
measure: The EORTC Core Quality of Life questionnaire-30 (EORTC QLQ-C30)
timeFrame: 40 days
measure: The EORTC Quality of life - Head and Neck Cancer Module (EORTC QLQ-H & N35)
timeFrame: 40 days
measure: Albumin
timeFrame: 40 days
measure: C-reactive protein
timeFrame: 40 days
measure: Prealbumin
timeFrame: 40 days
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 40 days
measure: Complication development status
timeFrame: 40 days
Other outcomes:
Locations:
city: Talas
country: Turkey
facility: Erciyes University
state: Kayseri
Study officials:
References: