Effect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition
Recruiting
Phase 3Interventional Study
Nasopharyngeal CarcinomaNutrition Therapy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
266 (estimated)
Sponsor
Sun Yat-sen University · Other
Who this trial is looking for
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Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
Eligibility Criteria
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 o…
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;
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