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

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Recruiting
participants needed

266
sponsor

Sun Yat-sen University

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Updated on 19 February 2024

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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 Identifier	NCT04436965
Sponsor	Sun Yat-sen University
Last Modified on	19 February 2024

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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

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