Neoplasms

All Conditions

Symptoms and General Pathology

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Weight Loss

Body Weight

Nasopharyngeal Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Body Weight Changes

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

In addition to conventional dietary instruction and individualized nutritional counselling, patients were given additional ONS (Abbott®Ensure of 55.8 g tid) from the beginning to the end of radiotherapy.

Conventional dietary instruction and individualized nutritional counselling from the beginning to the end of radiotherapy.

Abbott®Ensure: 55.8 g each time, three times a day, from the beginning to the end of radiotherapy

Abbott®Ensure

The prescribed dose was 68-76 Gy to Planning target volume of the primary tumor (PTVnx), 66-70 Gy to Planning target volume of the cervical lymph node (PTVnd), 60-64 Gy to planning target volume 1 (PTV1), and 50-54 Gy to planning target volume 2 (PTV2) in 30-33 fractions. The details of dose limits for organs at risk were based on the study 0225 from The Radiation Therapy Oncology Group (RTOG 0225).

Intensity Modulated Radiation Therapy

80-100 mg/m² cisplatin given intravenously every 3 weeks concurrently with radiotherapy.

cisplatin

Jinsheng Hong

Benhua Xu

Li Su

Shaojun Lin

Zhichao Fu

Rongqiang Liu

Zilong Chen

Zhigang Bai

Qin Lin

Haijie Lu

Jianli Huang

Jian Guan

Yaqian Han

Xiaochang Gong

Concurrent chemoradiotherapy(CCRT) is the principal treatment for nasopharyngeal carcinoma(NPC). Studies have shown that malnutrition is very common in patients with NPC after chemoradiotherapy. Malnutrition can lead to weight loss, treatment interruption, prolonged stay in hospital, increased treatment costs, reduced tolerance to anti-tumor therapy, reduced quality of life and shortened survival time. Nutritional intervention can improve the nutritional status, reduce treatment-related toxicity and improve the survival of patients with NPC.

The first choice of nutritional intervention is oral nutritional supplements(ONS). Some retrospective studies with small samples have found that early nutritional intervention can reduce weight loss and severe oral mucositis in patients with NPC, compared with late nutritional intervention. Therefore, the investigators proposed the hypothesis that ONS from the beginning of radiotherapy can reduce the nutritional impairment, treatment-related toxicity and treatment costs of patients with NPC, and improve their quality of life. The aim of this multicenter randomized controlled clinical trial is to evaluate the efficacy and cost utility of ONS from the beginning to the end of radiotherapy.

Effect of Oral Nutritional Supplements on Body Weight Loss of Patients With Nasopharyngeal Carcinoma

Effect of Oral Nutritional Supplements From the Beginning of Radiotherapy on Body Weight Loss of Patients With Nasopharyngeal Carcinoma and Its Cost-Utility Analysis: A Prospective Multicenter Randomized Controlled Trial

The percentage of patients whose body weight decreased more than 5% over baseline, body weight (in kilograms) are measured at baseline and weekly during the course of radiotherapy

The scores assessed by Patient-Generated Subjective Nutrition Assessment (PG-SGA) at baseline and weekly during the course of radiotherapy

Incidence of grade 3-4 oral mucositis assessed by CTCAE v5.0, evaluated weekly during radiotherapy

The number of days that radiotherapy was interrupted due to treatment-related toxicity

The standard scores assessed by the EORTC QLQ-C30 v3.0 at baseline and the end of radiotherapy.

The Increment cost-utility ratio is used to assess the economics of ONS, which is calculated as incremental cost divided by incremental utility.

The standard scores assessed by the EuroQol- 5 dimension-5 level (EQ-5D-5L ) questionnaire. Collect this questionnaire only in the responsible center.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Oral Nutritional Supplements on Body Weight Loss of Patients With Nasopharyngeal Carcinoma	NCT04823468	Nasopharyngeal ... Nutritional Sup...	Abbott®Ensure Intensity Modul... cisplatin	18 Years - 70 Years	First Affiliated Hospital of Fujian Medical University
Effect of Oral Nutritional Supplements on Body Weight Loss of Patients With Nasopharyngeal Carcinoma	NCT04823468	Nasopharyngeal ... Nutritional Sup...	Abbott®Ensure Intensity Modul... cisplatin	18 Years - 70 Years	First Affiliated Hospital of Fujian Medical University
Effect of Oral Nutritional Supplements on Body Weight Loss of Patients With Nasopharyngeal Carcinoma	NCT04823468	Nasopharyngeal ... Nutritional Sup...	Abbott®Ensure Intensity Modul... cisplatin	18 Years - 70 Years	First Affiliated Hospital of Fujian Medical University

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