The Function of PA, RBP and TRSF in Malnutrition Detecting and Nutritional Status Monitoring for NPC Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Nasopharyngeal Carcinoma, Malnutrition

Intervention / Treatment
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* Drug: cisplatin and docetaxel
* Radiation: IMRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CCRT±NACT<br>Patients treated with neoadjuvant chemotherapy(NC) (cisplatin and docetaxel) and CCRT (cisplatin) , or treated with CCRT only | Drug: cisplatin and docetaxel<br>* NACt：cisplatin 75 mg/m2 intravenous infusion in day1，docetaxel 75 mg/m2 intravenous infusion in day1，both drugs are given every 3 weeks, two cycles. CCRT: cisplatin (100mg/m2 on day 1) every three weeks for two cycles.<br>Radiation: IMRT<br>* intensity modulation radiation therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of PA/RBP/TRSF | to evaluate the changes of PA/RBP/TRSF during the treatment | baseline and during treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Body weight | to compare the change of weight loss during treatment | baseline and during treatment | 
| Number of Participants With Abnormal Laboratory Values | To observe the complete blood cell count and blood biochemical examination during treatment | baseline and during treatment | 
| Acute Toxicity | To evaluate the acute toxicity with Common Terminology Criteria For Adverse Events (CTCAE) 4.0 | baseline and during treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pre-Albumin, Retinol Conjugated Protein, Transferrin, Locoregionally Advanced Nasopharyngeal Carcinoma, nutrition