Clinical trial · Interventional
Effect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition
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
NCT04436965CI-TRIAL-00111044recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Nutrition Therapy | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Intensity Modulated Radiation Therapy | Radiation | — | UNRESOLVED |
| Standardized nutrition therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 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.
- interventionNames
- Other: Standardized nutrition therapy
- Drug: Cisplatin
- Radiation: Intensity Modulated Radiation Therapy
- type
- ACTIVE_COMPARATOR
- label
- Conventional nutrition therapy
- description
- Dynamic nutrition assessment will be performed to patients throughout whole treatment, and symptomatic treatment would be performed if needed.
- interventionNames
- Drug: Cisplatin
- Radiation: Intensity Modulated Radiation Therapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available
No reference posted for this study.