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

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03240835
• Other study ID #: NPC-PA/RBP/TRSF
• Status: Active, not recruiting
• Start date: September 12, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Malnutrition
• Nasopharyngeal Carcinoma

Intervention

Drug:
• cisplatin and docetaxel
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.

Radiation:
• IMRT
intensity modulation radiation therapy

Locations

Country	Name	City	State
China	Cancer Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Zhao Chong	Wu Jieping Medical Foundation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes of PA/RBP/TRSF	to evaluate the changes of PA/RBP/TRSF during the treatment	baseline and during treatment
Secondary	Change of Body weight	to compare the change of weight loss during treatment	baseline and during treatment
Secondary	Number of Participants With Abnormal Laboratory Values	To observe the complete blood cell count and blood biochemical examination during treatment	baseline and during treatment
Secondary	Acute Toxicity	To evaluate the acute toxicity with Common Terminology Criteria For Adverse Events (CTCAE) 4.0	baseline and during treatment