RecruitingPhase 3NCT04436965

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: A Prospective, Multicenter, Phase III Randomized Control Clinical Trial

Sponsor

Sun Yat-sen University

Enrollment

266 participants

Start Date

Aug 16, 2021

Study Type

INTERVENTIONAL

Conditions

Nasopharyngeal Carcinoma Nutrition Therapy

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria12

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 Criteria9

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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Interventions

OTHERStandardized nutrition therapy

Standardized nutrition therapy with ONS, nasal feeding tube, PEG or parenteral nutrition

DRUGCisplatin

Patients in both arms received concurrent cisplatin chemotherapy:100 mg/m² cisplatin given intravenously every 3 weeks on days 1, 22 concurrently with radiotherapy.

RADIATIONIntensity Modulated Radiation Therapy

Patients in both arms received Intensity Modulated Radiation Therapy:All target volumes were outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes were defined in accordance with the International Commission on Radiation Units and Measurements Reports 83. The prescribed dose was 70-72 Gy to PTVnx (Planning target volume of the primary tumor), 64-70 Gy to PTVnd (Planning target volume of the cervical lymph node),60- 64Gy to PTV1 (Planning target volume 1), and 54-58 Gy to PTV2 (Planning target volume 2) in 30-32 fractions. The details of dose limits for organs at risk were based on the study 0225 from The Radiation Therapy Oncology Group (RTOG 0225).