Actively Recruiting

Phase 3
Age: 18Years - 65Years
All Genders
NCT04436965

Effect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition

Led by Sun Yat-sen University · Updated on 2026-05-11

266

Participants Needed

1

Research Sites

432 weeks

Total Duration

On this page

Sponsors

S

Sun Yat-sen University

Lead Sponsor

Z

Zhongnan Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is a multicenter, randomized controlled, phase III clinical trial. The purpose of this study is to evaluate the efficacy of standard nutrition treatment versus conventional nutrition treatment in local advanced nasopharyngeal carcinoma patients.

CONDITIONS

Official Title

Effect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Newly histologic diagnosis of nasopharyngeal carcinoma (WHO II/III)
  • All genders, aged 18 to 65 years
  • Karnofsky performance status (KPS) 60 80
  • Clinical stage III to IVa (AJCC/UICC 8th edition)
  • No significant digestive, nutritional, metabolic, or endocrine diseases
  • No significant cardiac, respiratory, kidney, or liver diseases
  • No prior radiotherapy, chemotherapy, or other anti-tumor treatments including immunotherapy
  • White blood cell count 60 4�d7109/L, neutrophil granulocyte count 60 1.5�d7109/L, hemoglobin 60 9 g/L, platelet count 60 100�d7109/L
  • Total bilirubin, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than 2.5 times the upper limit of normal
  • Adequate renal function: BUN/CRE 60 1.5 times upper limit of normal or creatinine clearance 60 60 ml/min (Cockcroft-Gault formula)
  • No contraindications to chemotherapy or radiotherapy
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Contraindications to PEG/PEJ such as coagulopathy, recent anticoagulant or aspirin use, gastric ulcers or bleeding history, portal hypertension with varices, pyloric obstruction after gastrectomy
  • Presence of distant metastases
  • Other malignant tumors
  • Participation in other clinical trials
  • Drug or alcohol addiction
  • Lack of full legal capacity
  • Mental disorders
  • Pregnancy or breastfeeding
  • Severe complications such as uncontrolled hypertension

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510060

Actively Recruiting

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Research Team

J

Jingjing Miao, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Effect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition | DecenTrialz