Effect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition
- Conditions
- Nasopharyngeal CarcinomaNutrition Therapy
- Interventions
- Other: Standardized nutrition therapyRadiation: Intensity Modulated Radiation TherapyDrug: Cisplatin
- Registration Number
- NCT04436965
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 266
- 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;
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional nutrition therapy Intensity Modulated Radiation Therapy Dynamic nutrition assessment will be performed to patients throughout whole treatment, and symptomatic treatment would be performed if needed. Standard nutrition therapy Standardized nutrition therapy 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. Standard nutrition therapy Cisplatin 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. Standard nutrition therapy Intensity Modulated Radiation Therapy 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. Conventional nutrition therapy Cisplatin Dynamic nutrition assessment will be performed to patients throughout whole treatment, and symptomatic treatment would be performed if needed.
- Primary Outcome Measures
Name Time Method The incidence of IBW% 2 months 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
- Secondary Outcome Measures
Name Time Method The incidence of WL、UBW% and BMI 36 months 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
Number of Participants With Abnormal Laboratory Values 36 months To observe patients' complete blood cell count and blood biochemical examination during the treatment and three years after the treatment.
Overall survival 36 months From date of recruited to death
Progression free survival 36 months From date of recruited to disease progression
Locoregional recurrence free survival 36 months From date of recruited to locoregional recurrence
Distant metastasis free survival 36 months From date of recruited to distant metastasis
Nutrition screening and evaluation 36 months To observe the changes and differences of nutrition screening and evaluation (NRS2002 and PG-SGA) before, during and after treatment in the two groups
Quality of life: EuroQoL 5 dimension 36 months Evaluating with questionnaire of EuroQoL 5 dimension, 5 level health state utility index (EQ-5D-5L)
Acute toxicities through study completion, an average of 2 months Evaluating with CTCAE v5.0
Late toxicity 36 months assessed with Radiation Therapy Oncology Group radiation morbidity scoring criteria
Trial Locations
- Locations (1)
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China