NCT03240835已完成不适用
The Function of Pre-Albumin, Retinol Conjugated Protein and Transferrin in Early Malnutrition Detecting and Nutritional Status Dynamic Monitoring for Local Advanced Nasopharyngeal Carcinoma Patients With Chemoradiotherapy
Zhao Chong1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年9月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- changes of PA/RBP/TRSF
研究概览
简要总结
The purpose of this study is to study the function of pre-albumin, retinol conjugated protein and transferrin in early malnutrition detecting and nutritional status dynamic monitoring for local advanced nasopharyngeal carcinoma patients with chemoradiotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III)
- •All genders，range from 18～60 years old
- •Karnofsky performance status(KPS) ≥ 80
- •Clinical stage III~IVb(UICC 8th)
- •Without significant digestive system disease，nutritional and metabolic diseases or endocrine disease
- •Without significant cardiac，respiratory，kidney or liver disease
- •Not received radiotherapy, chemotherapy and other anti-tumor treatment(including immunotherapy)
- •white blood cell(WBC) count ≥ 4×109/L, neutrophile granulocyte(NE) count ≥ 1.5×109/L, Hemoglobin(HGB) ≥ 10g/L, platelet(PLT) count ≥ 100×109/L
- •alanine aminotransferase (ALT) or aspartate aminotransferase(AST) < 1.5×upper limit of normal(ULN), bilirubin < 1.5×ULN, alanine aminotransferase (CCR) ≥ 30ml/min
- •Inform consent form
排除标准
- •Distance metastases
- •Second malignancy within 5 years
- •Drug or alcohol addition
- •Do not have full capacity for civil acts
- •Active systemic infections
- •Chronic consumptions
- •Mental disorder
- •Pregnancy or lactation
- •Concurrent immunotherapy or hormone therapy for other diseases
- •Severe complication, eg, uncontrolled hypertension
研究组 & 干预措施
CCRT±NACT
Patients treated with neoadjuvant chemotherapy(NC) (cisplatin and docetaxel) and CCRT (cisplatin) , or treated with CCRT only
干预措施: IMRT (Radiation)
CCRT±NACT
Patients treated with neoadjuvant chemotherapy(NC) (cisplatin and docetaxel) and CCRT (cisplatin) , or treated with CCRT only
干预措施: cisplatin and docetaxel (Drug)
结局指标
主要结局
changes of PA/RBP/TRSF
时间窗: baseline and during treatment
to evaluate the changes of PA/RBP/TRSF during the treatment
次要结局
- Change of Body weight(baseline and during treatment)
- Number of Participants With Abnormal Laboratory Values(baseline and during treatment)
- Acute Toxicity(baseline and during treatment)
研究者
Zhao Chong
Clinical Professor
Sun Yat-sen University
研究点 (1)
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