Malnutrition, Nasopharyngeal Carcinoma
Conditions
Keywords
pre-Albumin, Retinol Conjugated Protein, Transferrin, Locoregionally Advanced Nasopharyngeal Carcinoma, nutrition
Brief summary
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.
Interventions
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.
RADIATIONIMRT
intensity modulation radiation therapy
Sponsors
Zhao Chong
Wu Jieping Medical Foundation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes of PA/RBP/TRSF | baseline and during treatment | to evaluate the changes of PA/RBP/TRSF during the treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Body weight | baseline and during treatment | to compare the change of weight loss during treatment |
| Number of Participants With Abnormal Laboratory Values | baseline and during treatment | To observe the complete blood cell count and blood biochemical examination during treatment |
| Acute Toxicity | baseline and during treatment | To evaluate the acute toxicity with Common Terminology Criteria For Adverse Events (CTCAE) 4.0 |
Countries
China
Outcome results
None listed