Effect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition
Recruiting now · Phase 3
Conditions studied: Nasopharyngeal Carcinoma, Nutrition Therapy
In brief
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.
Key facts
- Study ID
- NCT04436965
- Run by
- Sun Yat-sen University
- People needed
- 266
- Starts
- 2021-08-16
- Expected to finish
- 2029-12-01
- Last updated by the study team
- 2026-05-11
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
You may not qualify if…
- 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;
Where it is running
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.