A Randomized Clinical Trial With Perioperative Immunonutrition Support on Anthropometric, Clinical and Biochemical Parameters of Head and Neck Cancer Patients Undergoing Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- TC Erciyes University
- Enrollment
- 34
- Locations
- 2
- Primary Endpoint
- Albumin
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
immunonutrition (intervention group)
Immunonutrition enteral products was given to the patients in the intervention group
Intervention: Experimental (Immunonutrition) Group (Dietary Supplement)
standard (control group)
Standard enteral products was given to patients in the control group.
Intervention: Active Comparator Group ( Standard enteral nutrition) (Dietary Supplement)
Outcomes
Primary Outcomes
Albumin
Time Frame: 40 days
g/dL
Nutrition Risk Screening 2002
Time Frame: 40 days
A total score of ≥3 indicates that the patient is at nutritional risk
Body weight
Time Frame: 40 days
Kg
Body weight loss
Time Frame: 40 days
Kg
Body mass index
Time Frame: 40 days
kg/m2
Resting metabolic rate
Time Frame: 40 days
kcal
The EORTC Core Quality of Life questionnaire-30 (EORTC QLQ-C30)
Time Frame: 40 days
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.
The EORTC Quality of life - Head and Neck Cancer Module (EORTC QLQ-H & N35)
Time Frame: 40 days
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).
C-reactive protein
Time Frame: 40 days
mg/L
Prealbumin
Time Frame: 40 days
mg/dL
Secondary Outcomes
- Complication development status(40 days)
- Length of hospital stay(40 days)
Investigators
Eda Başmısırlı
Asst. Prof. Dr.
TC Erciyes University