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

NCT ID: NCT03240835

Last Updated: 2023-01-31

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-12
• Study Completion Date: 2023-12-31

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.

Conditions

Nasopharyngeal Carcinoma; Malnutrition

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

CCRT±NACT

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

cisplatin and docetaxel

Intervention Type: DRUG

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.

IMRT

Intervention Type: RADIATION

intensity modulation radiation therapy

Interventions

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.

Intervention Type: DRUG

IMRT

intensity modulation radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wu Jieping Medical Foundation

OTHER

Sponsor Role: collaborator

Zhao Chong

OTHER

Sponsor Role: lead

Responsible Party

Zhao Chong

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

NPC-PA/RBP/TRSF

Identifier Type: -

Identifier Source: org_study_id