Effect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanc⦠(NCT04436965) | Clinical Trial Compass
RecruitingPhase 3
Effect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition
China266 participantsStarted 2021-08-16
Plain-language 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.
Who can participate
Age range18 Years ā 65 Years
SexALL
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Inclusion Criteria:
* Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III);
* All gendersļ¼range from 18ļ½65 years old;
* Karnofsky performance status(KPS) ā„ 80;
* Clinical stage III\~IVa(AJCC/UICC 8th);
* Without significant digestive system diseaseļ¼nutritional and metabolic diseases or endocrine disease
* Without significant cardiacļ¼respiratoryļ¼kidney or liver disease;
* Not received radiotherapy, chemotherapy and other anti-tumor treatment(including immunotherapy);
* White blood cell(WBC) count ā„ 4Ć109/L, neutrophile granulocyte(NE) count ā„ 1.5Ć109/L, Hemoglobin(HGB) ā„ 9g/L, platelet(PLT) count ā„ 100Ć109/L
* Total bilirubin(TBIL)ćalanine aminotransferase (ALT) or aspartate aminotransferase(AST) \< 2.5Ćupper limit of normal(ULN);
* Adequate renal function: BUN/CRE ⤠1.5ĆULN or endogenous creatinine clearance ā„ 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 ciā¦