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

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.

Study Overview

• Status: Recruiting
• Conditions: Nasopharyngeal Carcinoma; Nutrition Therapy
• Intervention / Treatment: Other: Standardized nutrition therapy; Drug: Cisplatin; Radiation: Intensity Modulated Radiation Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 266
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jingjing Miao, MD; Phone Number: 86-13631355201; Email: miaojingjing90@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-Sen University Cancer Center
      • Contact: Chong Zhao, MD; Phone Number: 02087342638; Email: zhaochong@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Standard nutrition therapy; Dynamic nutrition assessment will be performed to patients. If malnutrion happened, patients would receive oral nutritional supplements (ONS) first, then feeded with nasal feeding tube or PEG when ONS wasn't enough. If all the these enteral nutrition methods couldn't make up for patient's nutritional deficiencies, parenteral nutrition would be considered.	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.; Other Names: DDP; 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).; Other Names: IMRT
ACTIVE_COMPARATOR: Conventional nutrition therapy; Dynamic nutrition assessment will be performed to patients throughout whole treatment, and symptomatic treatment would be performed if needed.	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.; Other Names: DDP; 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).; Other Names: IMRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of IBW%	To observe the changes and differences in the incidence of the actual weight/ideal weight (IBW%) less than 90% during the treatment of the two groups of patients	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of WL、UBW% and BMI	To observe the changes and differences in the incidence of body weight loss (WL)≥5%/10%, actual body weight/usual body weight (UBW%), body mass index (BMI) before, during and after treatment	36 months
Number of Participants With Abnormal Laboratory Values	To observe patients' complete blood cell count and blood biochemical examination during the treatment and three years after the treatment.	36 months
Overall survival	From date of recruited to death	36 months
Progression free survival	From date of recruited to disease progression	36 months
Locoregional recurrence free survival	From date of recruited to locoregional recurrence	36 months
Distant metastasis free survival	From date of recruited to distant metastasis	36 months
Nutrition screening and evaluation	To observe the changes and differences of nutrition screening and evaluation (NRS2002 and PG-SGA) before, during and after treatment in the two groups	36 months
Quality of life: EuroQoL 5 dimension	Evaluating with questionnaire of EuroQoL 5 dimension, 5 level health state utility index (EQ-5D-5L)	36 months
Acute toxicities	Evaluating with CTCAE v5.0	through study completion, an average of 2 months
Late toxicity	assessed with Radiation Therapy Oncology Group radiation morbidity scoring criteria	36 months

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Home Page of Cancer Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 16, 2021
• Primary Completion (ANTICIPATED): July 15, 2024
• Study Completion (ANTICIPATED): December 15, 2024

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (ACTUAL): June 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2023
• Last Update Submitted That Met QC Criteria: January 29, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Nutrition Disorders; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma; Malnutrition; Antineoplastic Agents; Cisplatin
• Other Study ID Numbers: 2019-FXY-348-NPC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No