Clinical trial NCT04436965: Effect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Nutrition Therapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Wuhan University
name: The First Affiliated Hospital of Xiamen University
name: Fudan University
name: Jiangxi Provincial Cancer Hospital
name: Xijing Hospital
name: Xiangya Hospital of Central South University
name: Fujian Cancer Hospital
name: Zhejiang Cancer Hospital
name: Cancer Hospital of Guizhou Province
First posted: 2020-06-18
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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 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;

Primary outcomes:
measure: The incidence of IBW%
timeFrame: 2 months
Secondary outcomes:
measure: The incidence of WL、UBW% and BMI
timeFrame: 36 months
measure: Number of Participants With Abnormal Laboratory Values
timeFrame: 36 months
measure: Overall survival
timeFrame: 36 months
measure: Progression free survival
timeFrame: 36 months
measure: Locoregional recurrence free survival
timeFrame: 36 months
measure: Distant metastasis free survival
timeFrame: 36 months
measure: Nutrition screening and evaluation
timeFrame: 36 months
measure: Quality of life: EuroQoL 5 dimension
timeFrame: 36 months
measure: Acute toxicities
timeFrame: through study completion, an average of 2 months
measure: Late toxicity
timeFrame: 36 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Chong Zhao, MD
role: PRINCIPAL_INVESTIGATOR
References: