A Randomized Clinical Trial With Perioperative Immunonutrition Support on Anthropometric, Clinical and Biochemical Parameters of Head and Neck Cancer Patients Undergoing Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Albumin
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
immunonutrition (intervention group)
Immunonutrition enteral products was given to the patients in the intervention group
干预措施: Experimental (Immunonutrition) Group (Dietary Supplement)
standard (control group)
Standard enteral products was given to patients in the control group.
干预措施: Active Comparator Group ( Standard enteral nutrition) (Dietary Supplement)
结局指标
主要结局
Albumin
时间窗: 40 days
g/dL
Body mass index
时间窗: 40 days
kg/m2
Resting metabolic rate
时间窗: 40 days
kcal
Body weight
时间窗: 40 days
Kg
Body weight loss
时间窗: 40 days
Kg
Nutrition Risk Screening 2002
时间窗: 40 days
A total score of ≥3 indicates that the patient is at nutritional risk
The EORTC Core Quality of Life questionnaire-30 (EORTC QLQ-C30)
时间窗: 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)
时间窗: 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
时间窗: 40 days
mg/L
Prealbumin
时间窗: 40 days
mg/dL
次要结局
- Complication development status(40 days)
- Length of hospital stay(40 days)
研究者
Eda Başmısırlı
Asst. Prof. Dr.
TC Erciyes University