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

Active, not recruiting

• Conditions: Nasopharyngeal Carcinoma; Malnutrition
• Interventions: Drug: cisplatin and docetaxel; Radiation: IMRT

• Registration Number: NCT03240835
• Lead Sponsor: Zhao Chong

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-27
• Study First Submitted QC: 2017-08-01
• Study First Posted: 2017-08-07
• Study Start: 2017-09-12
• Primary Completion: 2018-12-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-29
• Last Update Posted: 2023-01-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CCRT±NACT	cisplatin and docetaxel	Patients treated with neoadjuvant chemotherapy(NC) (cisplatin and docetaxel) and CCRT (cisplatin) , or treated with CCRT only
CCRT±NACT	IMRT	Patients treated with neoadjuvant chemotherapy(NC) (cisplatin and docetaxel) and CCRT (cisplatin) , or treated with CCRT only

Primary Outcome Measures

Name	Time	Method
changes of PA/RBP/TRSF	baseline and during treatment	to evaluate the changes of PA/RBP/TRSF during the treatment

Secondary Outcome Measures

Name	Time	Method
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
Change of Body weight	baseline and during treatment	to compare the change of weight loss during treatment

Trial Locations

Locations (1)

Cancer Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China