Nasopharyngeal Carcinoma, Nutritional Support
Conditions
Keywords
Nasopharyngeal Carcinoma, Nutritional Support, Chemoradiotherapy, Dietary Supplements, Body Weight, Cost-Effectiveness Analysis
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTAbbott®Ensure
Abbott®Ensure: 55.8 g each time, three times a day, from the beginning to the end of radiotherapy
RADIATIONIntensity Modulated Radiation Therapy
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).
DRUGcisplatin
80-100 mg/m² cisplatin given intravenously every 3 weeks concurrently with radiotherapy.
Sponsors
Fujian Cancer Hospital
The Second Affiliated Hospital of Fujian Medical University
The Nanping First Affiliated Hospital of Fujian Medical University
Quanzhou First Hospital
Fujian Medical University Union Hospital
Zhangzhou Affiliated Hospital of Fujian Medical University
Hunan Cancer Hospital
Jiangxi Provincial Cancer Hospital
900 Hospital of Joint Logistics Support Force of PLA
Nanfang Hospital, Southern Medical University
The First Affiliated Hospital of Xiamen University
Zhongshan Hospital Xiamen University
Jinsheng Hong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Newly histologic diagnosis of nasopharyngeal carcinoma; * All genders, range from 18-70 years old; * Clinical stage II-IVa according to the 8th edition of the Union for International Cancer Control/American Joint Committee on Cancer (UICC/AJCC) staging system; * Patient-Generated Subjective Nutrition Assessment (PG-SGA) score ≤8; * Main organ functions test should be satisfied the following conditions: (1) Absolute neutrophil count (ANC) ≥1.5×10\^9/L; (2) Platelet (PLT) ≥80×10\^9/L; (3) Hemoglobin (Hb) ≥90 g/L; (4) Bilirubin \< 1.5 times the upper limit of normal value (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 times the upper limit of normal value; (5) Creatinine \< 1.5 times the upper limit of normal value or creatinine clearance rate \>60 ml/min.
Exclusion criteria
* Patients whose energy intake is less than 60% of the target energy requirement for 3 days or more; * Have or are suffering from other malignant tumors; * Refuse concurrent chemoradiotherapy; * With diabetics, galactosemia, or sever metabolic diseases or endocrine diseases; * Cannot take oral or enteral nutrition, including intestinal obstruction, severe short bowel syndrome or high output fistula, or with severe digestive system diseases; * Known allergic reaction to any component of Abbott®Ensure, or severe allergic constitution; * Pregnant or lactating women; * With previous or ongoing clinical trials; * Refuse to sign inform consent form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of weight loss > 5% | From time of randomization to the date of radiotherapy ends, up to 7 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of participants with grade ≥3 oral mucositis | During the course of radiotherapy, up to 7 weeks | Incidence of grade 3-4 oral mucositis assessed by CTCAE v5.0, evaluated weekly during radiotherapy |
| Days of radiotherapy interruption | During the course of radiotherapy, up to 7 weeks | The number of days that radiotherapy was interrupted due to treatment-related toxicity |
| PG-SGA Score | From time of randomization to the date of radiotherapy ends, up to 7 weeks | The scores assessed by Patient-Generated Subjective Nutrition Assessment (PG-SGA) at baseline and weekly during the course of radiotherapy |
| Increment Cost-Utility Ratio (ICUR） | During the course of chemoradiotherapy, up to 7 weeks | The Increment cost-utility ratio is used to assess the economics of ONS, which is calculated as incremental cost divided by incremental utility. |
| Score of EQ-5D-5L questionnaire | During the course of chemoradiotherapy, up to 7 weeks | The standard scores assessed by the EuroQol- 5 dimension-5 level (EQ-5D-5L ) questionnaire. Collect this questionnaire only in the responsible center. |
| Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 v3.0 (EORTC QLQ-C30 v3.0) | From time of randomization to the date of radiotherapy ends, up to 7 weeks | The standard scores assessed by the EORTC QLQ-C30 v3.0 at baseline and the end of radiotherapy. |
Countries
China
Outcome results
None listed