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| Name | Class |
|---|---|
| Zhongnan Hospital | OTHER |
| The First Affiliated Hospital of Xiamen University | OTHER |
| Fudan University | OTHER |
| Jiangxi Provincial Cancer Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard nutrition therapy | Experimental | 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. |
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| Conventional nutrition therapy | Active Comparator | Dynamic nutrition assessment will be performed to patients throughout whole treatment, and symptomatic treatment would be performed if needed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized nutrition therapy | Other | Standardized nutrition therapy with ONS, nasal feeding tube, PEG or parenteral nutrition |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingjing Miao, MD | Contact | 86-13631355201 | miaojingjing90@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chong Zhao, MD | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| Label | URL |
|---|---|
| Home Page of Cancer Center, Sun Yat-sen University | View source |
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| OTHER |
| Xijing Hospital | OTHER |
| Xiangya Hospital of Central South University | OTHER |
| Fujian Cancer Hospital | OTHER_GOV |
| Zhejiang Cancer Hospital | OTHER |
| Cancer Hospital of Guizhou Province | OTHER |
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| Cisplatin | Drug | Patients in both arms received concurrent cisplatin chemotherapy:100 mg/m² cisplatin given intravenously every 3 weeks on days 1, 22 concurrently with radiotherapy. |
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| Intensity Modulated Radiation Therapy | Radiation | 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). |
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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 |
| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| 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 |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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