Effect of Chemoradiotherapy on Nutritional Status in Advanced NPC Patients

Zhao Chong

Status: Completed

Conditions: Malnutrition; Nasopharyngeal Carcinoma

Treatments: Drug: cisplatin and docetaxel

Study type: Observational

Funder types: Other

Identifiers

NCT02575547

2015-FXY-034-Nutrition and NPC

Details and patient eligibility

About

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。

Enrollment: 186 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

186 participants in 1 patient group

NC+CCRT

Description:

Patients treated with neoadjuvant chemotherapy(NC) (cisplatin and docetaxel) and CCRT (cisplatin)

Treatment:

Drug: cisplatin and docetaxel