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Recruiting NCT04436965

Effect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition

Phase III Interventional Nasopharyngeal Carcinoma Nutrition Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standardized nutrition therapy, Cisplatin, Intensity Modulated Radiation Therapy.
Who it may be relevant to
Registry conditions: Nasopharyngeal Carcinoma, Nutrition Therapy. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Other Standardized nutrition therapy
    Standardized nutrition therapy with ONS, nasal feeding tube, PEG or parenteral nutrition
  • Drug Cisplatin
    Patients in both arms received concurrent cisplatin chemotherapy:100 mg/m² cisplatin given intravenously every 3 weeks on days 1, 22 concurrently with radiotherapy.
  • Radiation Intensity Modulated Radiation Therapy
    Patients in both arms received Intensity Modulated Radiation Therapy:All target volumes were outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes were defined in accordance with the International Commission on Radiation Units and Measurements Reports 83. The prescribed dose was 70-72 Gy to PTVnx (Planning target volume of the primary tumor), 64-70 Gy to PTVnd (Planning target volume of the cervical lymph node),60- 64

Primary outcome measures

  • The incidence of IBW% [Time frame: 2 months]
Secondary outcome measures (10)
  • The incidence of WL、UBW% and BMI [Time frame: 36 months]
  • Number of Participants With Abnormal Laboratory Values [Time frame: 36 months]
  • Overall survival [Time frame: 36 months]
  • Progression free survival [Time frame: 36 months]
  • Locoregional recurrence free survival [Time frame: 36 months]
  • Distant metastasis free survival [Time frame: 36 months]
  • Nutrition screening and evaluation [Time frame: 36 months]
  • Quality of life: EuroQoL 5 dimension [Time frame: 36 months]
  • Acute toxicities [Time frame: through study completion, an average of 2 months]
  • Late toxicity [Time frame: 36 months]

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Sun Yat-sen University Cancer Center — Guangzhou

Identifiers

NCT: NCT04436965 · 2019-FXY-348-NPC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗