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

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

Recruiting
18-65 years
All
Phase 3

Overview

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.

Eligibility

Inclusion Criteria:

  • Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III);
  • All gendersrange from 1865 years old;
  • Karnofsky performance status(KPS) 80;
  • Clinical stage III~IVa(AJCC/UICC 8th);
  • Without significant digestive system diseasenutritional and metabolic diseases or endocrine disease
  • Without significant cardiacrespiratorykidney or liver disease;
  • Not received radiotherapy, chemotherapy and other anti-tumor treatment(including immunotherapy);
  • White blood cell(WBC) count 4109/L, neutrophile granulocyte(NE) count 1.5109/L, Hemoglobin(HGB) 9g/L, platelet(PLT) count 100109/L
  • Total bilirubin(TBIL)alanine aminotransferase (ALT) or aspartate aminotransferase(AST) 2.5upper limit of normal(ULN);
  • Adequate renal function: BUN/CRE 1.5ULN or endogenous creatinine clearance 60ml/min (Cockcroft-Gault formula);
  • No contraindications to chemotherapy or radiotherapy;
  • Inform consent form;

Exclusion Criteria:

  • Have some PEG/PEJ contraindications, such as coagulopathy, recent anticoagulant medications and aspirin, gastric ulcer or history of gastric bleeding, portal hypertension combined with abdominal and esophageal fundal varices, pyloric obstruction due to residual stomach under the costal arch after various major gastrectomy or various reasons;
  • Distance metastases;
  • Have or are suffering from other malignant tumors;
  • Participating in other clinical trials;
  • Drug or alcohol addition;
  • Do not have full capacity for civil acts;
  • Mental disorder;
  • Pregnancy or lactation;
  • Severe complication, eg, uncontrolled hypertension;

Study details
    Carcinoma
    vulvar dysplasia and carcinoma
    Nasopharyngeal Cancer
    Nasopharyngeal Cancer
    Nutrition Therapy
    Nutritional Support
    vulvar dysplasia and carcinoma

NCT04436965

Sun Yat-sen University

5 August 2020

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