Malnutrition, Nasopharyngeal Carcinoma
Conditions
Keywords
Nutritional Status, Locoregionally Advanced Nasopharyngeal Carcinoma
Brief summary
This is an prospective，open-label, none-interventional, observational， multicenter phase II clinical trial. The purpose of this study is to observe the effect of neoadjuvant chemotherapy followed by concurrent chemoradiation therapy(CCRT) on nutritional status in locoregionally advanced nasopharyngeal carcinoma(NPC) patients, analyse the changes of patients' nutrition status during the treatment and the connection between nutrition changes and curative effects, evaluate nutritional risks under the neoadjuvant chemotherapy and CCRT and provide data and basis for further study。
Interventions
NC：cisplatin 75 mg/m2 intravenous infusion in day1，docetaxel 75 mg/m2 intravenous infusion in day1，both drugs are given every 3 weeks, two courses. CCRT: intensity modulation radiation therapy(IMRT) and cisplatin (100mg/m2 on day 1) every three weeks for three\\three cycles during radiation therapy(RT). Dietary supplement: enteral nutrition and parenteral nutrition
Sponsors
Wuhan University
Fudan University
Fujian Cancer Hospital
Zhejiang Cancer Hospital
First Affiliated Hospital of Guangxi Medical University
The First Affiliated Hospital of Xiamen University
Cancer Hospital of Guizhou Province
Hainan People's Hospital
First People's Hospital of Foshan
Zhao Chong
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II) * All genders，range from 18～65 years old * Karnofsky performance status(KPS) ≥ 80 * Clinical stage III\ IVb(UICC 7th) * 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 |
|---|---|
| Change in Body weight | baseline and 36 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Abnormal Laboratory Values | 36 months | To observe patients' complete blood cell count and blood biochemical examination during the treatment and three years after the treatment. |
| Adverse Events That Are Related to Treatment | 36 months | Using European Organization for Research and Treatment of Cancer(EORTC) quality of life questionnaire(QLQ)-C30(version 3.0) and EORTC QLQ-H&N35(Version 1.0) to access the quality of life. Collecting data before treatment, 1 week after each 4/5 cycles of chemotherapy, 3 years after all treatment finished. |
| Tumor regressive rate after treatment | 36 months | — |
| Late toxicity | 36 months | To evaluate the late toxicity with the SOMA criterion after 1/2/3 years of treatment. |
| Acute Toxicity | 3 months | To evaluate the acute toxicity with Common Terminology Criteria For Adverse Events (CTCAE) 3.0 when adjuvant chemotherapy and concurrent chemoradiation is used. |
| Three-year distance metastasis free survival rate | 36 months | — |
| Three-year overall survival rate | 36 months | — |
| Three-year disease free survival rate | 36 months | — |
| Three-year locoregional relapse free survival rate | 36 months | — |
Countries
China
Outcome results
None listed