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| Name | Class |
|---|---|
| Fujian Cancer Hospital | OTHER_GOV |
| The Second Affiliated Hospital of Fujian Medical University | OTHER |
| The Nanping First Affiliated Hospital of Fujian Medical University | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | 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. |
|
| Control group | Other | Conventional dietary instruction and individualized nutritional counselling from the beginning to the end of radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abbott®Ensure | Dietary Supplement | Abbott®Ensure: 55.8 g each time, three times a day, from the beginning to the end of radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From time of randomization to the date of radiotherapy ends, up to 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PG-SGA Score | The scores assessed by Patient-Generated Subjective Nutrition Assessment (PG-SGA) at baseline and weekly during the course of radiotherapy | From time of randomization to the date of radiotherapy ends, up to 7 weeks |
| Incidence of participants with grade ≥3 oral mucositis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinsheng Hong | First Affiliated Hospital of Fujian Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350001 | China | ||
| First Affiliated Hospital of Fujian Medical University |
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| Quanzhou First Hospital |
| OTHER |
| Fujian Medical University Union Hospital | OTHER |
| Zhangzhou Affiliated Hospital of Fujian Medical University | OTHER |
| Hunan Cancer Hospital | OTHER |
| Jiangxi Provincial Cancer Hospital | OTHER |
| 900th Hospital of PLA Joint Logistic Support Force | OTHER |
| Nanfang Hospital, Southern Medical University | OTHER |
| The First Affiliated Hospital of Xiamen University | OTHER |
| Zhongshan Hospital Xiamen University | OTHER |
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| Intensity Modulated Radiation Therapy | Radiation | 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). |
|
| cisplatin | Drug | 80-100 mg/m² cisplatin given intravenously every 3 weeks concurrently with radiotherapy. |
|
Incidence of grade 3-4 oral mucositis assessed by CTCAE v5.0, evaluated weekly during radiotherapy |
| 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 | 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. | 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. | 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. | During the course of chemoradiotherapy, up to 7 weeks |
| Fuzhou |
| Fujian |
| 350005 |
| China |
| Fujian Cancer Hospital | Fuzhou | Fujian | 350014 | China |
| 900th hospital of the joint logistics team, PLA | Fuzhou | Fujian | 350025 | China |
| The Nanping First Affiliated Hospital of Fujian Medical University | Nanping | Fujian | 353000 | China |
| Quanzhou First Hospital Affiliated to Fujian Medical University | Quanzhou | Fujian | 362000 | China |
| The Second Affiliated Hospital of Fujian Medical University | Quanzhou | Fujian | 362000 | China |
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | 361003 | China |
| Zhongshan Hospital Xiamen University | Xiamen | Fujian | 361004 | China |
| Zhangzhou Affiliated Hospital of Fujian Medical University | Zhangzhou | Fujian | 363000 | China |
| Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong | 510515 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410013 | China |
| Jiangxi Provincial Cancer Hospital | Nanchang | Jiangxi | 330029 | China |
| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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