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

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.

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;

Conditions3

Interventions1

Related trials

• A Phase I/II Study of CS2009 in Participants With Advanced Solid Tumors — CStone Pharmaceuticals
• A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors — Mabwell (Shanghai) Bioscience Co., Ltd.
• A Randomised Trial of Chemotherapy Plus Surgery for Recurrent Non-Small Cell Lung Cancer — Shanghai Jiao Tong University School of Medicine
• A Single-center Phase II Study to Investigate the Immune Maintenance Therapy Pattern in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma Who Have Achieved MPR After Neoadjuvant Immunotherapy Combined With Chemotherapy — Tianjin Medical University Cancer Institute and Hospital
• A Study of Adebrelimab in Combination With Apatinib Gemcitabine and Cisplatin in Biliary Tract Malignancies — First Affiliated Hospital of Fujian Medical University
• A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC — Sichuan Baili Pharmaceutical Co., Ltd.
• A Study of Chemoradiation in Combination with Tislelizumab As First Line Treatment in Participants with Advanced Esophageal Squamous Cell Carcinoma — Renmin Hospital of Wuhan University
• A Study of Icotinib With Chemotherapy as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer — Peking University Cancer Hospital & Institute

Browse More Trials