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

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.

Conditions

• Nasopharyngeal Carcinoma
• Nutrition Therapy

Interventions

OTHER

Standardized nutrition therapy

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

DRUG

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.

RADIATION

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).

Sponsors & Collaborators

• Zhongnan Hospital

  collaborator OTHER

• The First Affiliated Hospital of Xiamen University

  collaborator OTHER

• Fudan University

  collaborator OTHER

• Jiangxi Provincial Cancer Hospital

  collaborator OTHER

• Xijing Hospital

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• Fujian Cancer Hospital

  collaborator OTHER_GOV

• Zhejiang Cancer Hospital

  collaborator OTHER

• Cancer Hospital of Guizhou Province

  collaborator OTHER

• Sun Yat-sen University

  lead OTHER

Principal Investigators

• Chong Zhao, MD · Sun Yat-Sen University Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-16

Primary Completion

2026-12-31

Completion

2029-12-31

Countries

• China

Study Locations