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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
236
Abbott®Ensure: 55.8 g each time, three times a day, from the beginning to the end of radiotherapy
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).
80-100 mg/m² cisplatin given intravenously every 3 weeks concurrently with radiotherapy.
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
900th hospital of the joint logistics team, PLA
Fuzhou, Fujian, China
The Nanping First Affiliated Hospital of Fujian Medical University
Nanping, Fujian, China
Quanzhou First Hospital Affiliated to Fujian Medical University
Quanzhou, Fujian, China
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China
Zhangzhou Affiliated Hospital of Fujian Medical University
Zhangzhou, Fujian, China
...and 3 more locations
Incidence of weight loss > 5%
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
Time frame: From time of randomization to the date of radiotherapy ends, up to 7 weeks
PG-SGA Score
The scores assessed by Patient-Generated Subjective Nutrition Assessment (PG-SGA) at baseline and weekly during the course of radiotherapy
Time frame: From time of randomization to the date of radiotherapy ends, up to 7 weeks
Incidence of participants with grade ≥3 oral mucositis
Incidence of grade 3-4 oral mucositis assessed by CTCAE v5.0, evaluated weekly during radiotherapy
Time frame: During the course of radiotherapy, up to 7 weeks
Days of radiotherapy interruption
The number of days that radiotherapy was interrupted due to treatment-related toxicity
Time frame: During the course of radiotherapy, up to 7 weeks
Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 v3.0 (EORTC QLQ-C30 v3.0)
The standard scores assessed by the EORTC QLQ-C30 v3.0 at baseline and the end of radiotherapy.
Time frame: From time of randomization to the date of radiotherapy ends, up to 7 weeks
Increment Cost-Utility Ratio (ICUR)
The Increment cost-utility ratio is used to assess the economics of ONS, which is calculated as incremental cost divided by incremental utility.
Time frame: During the course of chemoradiotherapy, up to 7 weeks
Score of EQ-5D-5L questionnaire
The standard scores assessed by the EuroQol- 5 dimension-5 level (EQ-5D-5L ) questionnaire. Collect this questionnaire only in the responsible center.
Time frame: During the course of chemoradiotherapy, up to 7 weeks
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