Effect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Nasopharyngeal Carcinoma, Nutrition Therapy

Intervention / Treatment
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* Other: Standardized nutrition therapy
* Drug: Cisplatin
* Radiation: Intensity Modulated Radiation Therapy


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard nutrition therapy<br>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. | Other: Standardized nutrition therapy<br>* Standardized nutrition therapy with ONS, nasal feeding tube, PEG or parenteral nutrition<br>Drug: Cisplatin<br>* Patients in both arms received concurrent cisplatin chemotherapy:100 mg/m² cisplatin given intravenously every 3 weeks on days 1, 22 concurrently with radiotherapy.<br>* Other names: DDP;Radiation: Intensity Modulated Radiation Therapy<br>* 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).<br>* Other names: IMRT;|
| Active Comparator: Conventional nutrition therapy<br>Dynamic nutrition assessment will be performed to patients throughout whole treatment, and symptomatic treatment would be performed if needed. | Drug: Cisplatin<br>* Patients in both arms received concurrent cisplatin chemotherapy:100 mg/m² cisplatin given intravenously every 3 weeks on days 1, 22 concurrently with radiotherapy.<br>* Other names: DDP;Radiation: Intensity Modulated Radiation Therapy<br>* 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).<br>* Other names: IMRT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |