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

  • STATUS
    Recruiting
  • participants needed
    266
  • sponsor
    Sun Yat-sen University
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Updated on 5 August 2020
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nasopharyngeal carcinoma
karnofsky performance status
carcinoma
liver disease
malnutrition
nutritional support
renal function test
intensity-modulated radiation therapy
endocrine disease
digestive system disease
cisplatin

Summary

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.

Details
Condition Carcinoma, vulvar dysplasia and carcinoma, Nasopharyngeal Cancer, Nasopharyngeal Cancer, Nutrition Therapy, Nutritional Support, vulvar dysplasia and carcinoma
Age 18years - 65years
Treatment Cisplatin, Intensity modulated radiation therapy, Standardized nutrition therapy
Clinical Study IdentifierNCT04436965
SponsorSun Yat-sen University
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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
Clear my responses
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nasopharyngeal carcinoma
karnofsky performance status
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malnutrition
nutritional support
renal function test
intensity-modulated radiation therapy
endocrine disease
digestive system disease
cisplatin

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