Nasopharyngeal Carcinoma Clinical Trial
Official title:
Effect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition: A Prospective, Multicenter, Phase III Randomized Control Clinical Trial
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.
Status | Recruiting |
Enrollment | 266 |
Est. completion date | December 15, 2024 |
Est. primary completion date | July 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III); - All genders,range from 18~65 years old; - Karnofsky performance status(KPS) = 80; - Clinical stage III~IVa(AJCC/UICC 8th); - Without significant digestive system disease,nutritional and metabolic diseases or endocrine disease - Without significant cardiac,respiratory,kidney or liver disease; - Not received radiotherapy, chemotherapy and other anti-tumor treatment(including immunotherapy); - White blood cell(WBC) count = 4×109/L, neutrophile granulocyte(NE) count = 1.5×109/L, Hemoglobin(HGB) = 9g/L, platelet(PLT) count = 100×109/L - Total bilirubin(TBIL)?alanine aminotransferase (ALT) or aspartate aminotransferase(AST) < 2.5×upper limit of normal(ULN); - Adequate renal function: BUN/CRE = 1.5×ULN or endogenous creatinine clearance = 60ml/min (Cockcroft-Gault formula); - No contraindications to chemotherapy or radiotherapy; - Inform consent form; Exclusion Criteria: - Have some PEG/PEJ contraindications, such as coagulopathy, recent anticoagulant medications and aspirin, gastric ulcer or history of gastric bleeding, portal hypertension combined with abdominal and esophageal fundal varices, pyloric obstruction due to residual stomach under the costal arch after various major gastrectomy or various reasons; - Distance metastases; - Have or are suffering from other malignant tumors; - Participating in other clinical trials; - Drug or alcohol addition; - Do not have full capacity for civil acts; - Mental disorder; - Pregnancy or lactation; - Severe complication, eg, uncontrolled hypertension; |
Country | Name | City | State |
---|---|---|---|
China | Sun Yat-sen University Cancer Center | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University | Cancer Hospital of Guizhou Province, Fudan University, Fujian Cancer Hospital, Jiangxi Provincial Cancer Hospital, The First Affiliated Hospital of Xiamen University, Wuhan University, Xiangya Hospital of Central South University, Xijing Hospital, Zhejiang Cancer Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | Number of Participants With Abnormal Laboratory Values | To observe patients' complete blood cell count and blood biochemical examination during the treatment and three years after the treatment. | 36 months | |
Secondary | Overall survival | From date of recruited to death | 36 months | |
Secondary | Progression free survival | From date of recruited to disease progression | 36 months | |
Secondary | Locoregional recurrence free survival | From date of recruited to locoregional recurrence | 36 months | |
Secondary | Distant metastasis free survival | From date of recruited to distant metastasis | 36 months | |
Secondary | 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 | |
Secondary | Quality of life: EuroQoL 5 dimension | Evaluating with questionnaire of EuroQoL 5 dimension, 5 level health state utility index (EQ-5D-5L) | 36 months | |
Secondary | Acute toxicities | Evaluating with CTCAE v5.0 | through study completion, an average of 2 months | |
Secondary | Late toxicity | assessed with Radiation Therapy Oncology Group radiation morbidity scoring criteria | 36 months |
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