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

• Status: Recruiting
• Trial end date: 2024-12-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborators: Cancer Hospital of Guizhou Province; Fudan University; Fujian Cancer Hospital; Jiangxi Provincial Cancer Hospital; The First Affiliated Hospital of Xiamen University; Wuhan University; Xiangya Hospital of Central South University; Xijing Hospital; Zhejiang Cancer Hospital
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

• Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III);

• All genders，range from 18～65 years old;

• Karnofsky performance status(KPS) ≥ 80;

• Clinical stage III~IVa(AJCC/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) ≥ 9g/L, platelet(PLT) count ≥ 100×109/L

• Total bilirubin(TBIL)、alanine aminotransferase (ALT) or aspartate aminotransferase(AST) < 2.5×upper limit of normal(ULN);

• Adequate renal function: BUN/CRE ≤ 1.5×ULN 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;