Comparison of Two Immunomodulatory Formulas on the Number of Postoperative Infections in Oropharyngeal and Maxillofacial Cancer Patients Eligible Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Number of postoperative infections
研究概览
简要总结
The purpose of this study is to evaluate the effect of an immune formula , consumed 10 days before surgery , on the number and characteristics of postoperative infections for a period of 30 days in a group of oropharynx, hypopharynx , larynx and oral cavity squamous cell cancer patients, candidates for surgery.
详细描述
68 subjects randomized into two study groups: 34 subjects consume the supplement of the study and 34 control consume the supplement IMPACT.
Intervention period will be 10 days before surgery . The consume amount is 400 ml/ day. The Subjects were stratified according to tumor location ( larynx and oral cavity and oropharynx, hypopharynx) and disease stage (early and advanced).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women >18 years
- •Patients with histologically confirmed squamous cell cancer of the oropharynx, hypopharynx , larynx and oral cavity and candidates for neoplastic surgery (undergoing surgery)
- •Adequate cultural level and understanding for the clinical trial. and agree to participate voluntarily in the study and give written informed consent
- •Patients who do not participate in other clinical trials
排除标准
- •Patients with an active infectious process at the time of the study.
- •Patients who have undergone radiotherapy / chemotherapy prior to surgery.
- •Subjects diagnosed with Type I Diabetes Mellitus
- •Subjects who used oral hypoglycemic agents or insulin.
- •Patients with severe kidney disease, heart, respiratory or liver.
- •Patients with autoimmune diseases or immunosuppressive drugs used.
- •Subjects with dementia, mental illness or diminished cognitive function.
- •Subjects who refuse oral supplements.
- •Subjects who consume vitamin supplements or artificial nutrition, and which can not be suspended at least 1 week before the study and do not accept to suspend it during the study.
- •Subjects with morbid obesity (BMI ≥ 40 kg / m2).
- •Pregnant or breastfeeding
- •Patients diagnosed with epidermoid carcinoma T1 glottic, cordectomy candidate.
研究组 & 干预措施
: IMPACT
along 10 days before surgery
干预措施: IMPACT (Dietary Supplement)
immunomodulatory supplement
along 10 days before surgery
干预措施: immunomodulatory supplement (Dietary Supplement)
结局指标
主要结局
Number of postoperative infections
时间窗: 30 days after surgery
次要结局
- Change from baseline Retinol-binding protein(0 and 30 days)
- Mortality(through study completion, an average of 3 months)
- change from baseline transferrin(0 and 30 days)
- change from baseline leukocytes(0 and 30 days)
- Length of post-operative hospital stay(through study completion, an average of 3 months)
- change from baseline Fibrinogen(0 and 30 days)
- change from baseline prealbumin(0 and 30 days)
- change from baseline Bioelectrical impedance analysis(0 and 30 days)
- change from baseline C-reactive protein(0 and 30 days)
- change from baseline albumin(0 and 30 days)