Status:
UNKNOWN
Effect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Wuhan University
The First Affiliated Hospital of Xiamen University
Conditions:
Nasopharyngeal Carcinoma
Nutrition Therapy
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
August 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2024
Estimated Enrollment :
266 Patients enrolled
Trial Details
Trial ID
NCT04436965
Start Date
August 16 2021
End Date
December 15 2024
Last Update
January 31 2023
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060