Brief Title
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
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
The incidence of IBW%
Secondary Outcome
The incidence of WL、UBW% and BMI
Condition
Nasopharyngeal Carcinoma
Intervention
Standardized nutrition therapy
Study Arms / Comparison Groups
Standard nutrition therapy
Description: Dynamic nutrition assessment will be performed to patients. If malnutrion happened, patients would receive oral nutritional supplements (ONS) first, then feeded with nasal feeding tube or PEG when ONS wasn't enough. If all the these enteral nutrition methods couldn't make up for patient's nutritional deficiencies, parenteral nutrition would be considered.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
266
Start Date
January 2021
Completion Date
December 15, 2024
Primary Completion Date
July 15, 2024
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;
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Chong Zhao, MD, 86-13631355201, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04436965
Organization ID
2019-FXY-348-NPC
Responsible Party
Principal Investigator
Study Sponsor
Sun Yat-sen University
Collaborators
Wuhan University
Study Sponsor
Chong Zhao, MD, Principal Investigator, Sun Yat-sen University
Verification Date
November 2020