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Effect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition
Sponsor: Sun Yat-sen University
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
266
Start Date
2021-08-16
Completion Date
2029-12
Last Updated
2026-05-11
Healthy Volunteers
No
Interventions
Standardized nutrition therapy
Standardized nutrition therapy with ONS, nasal feeding tube, PEG or parenteral nutrition
Cisplatin
Patients in both arms received concurrent cisplatin chemotherapy:100 mg/m² cisplatin given intravenously every 3 weeks on days 1, 22 concurrently with radiotherapy.
Intensity 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).
Locations (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China