Clinical trial · Observational
Effect of Chemoradiotherapy on Nutritional Status in Advanced NPC Patients
Effect of Neoadjuvant Chemotherapy Followed by Concurrent Chemo-radiotherapy on Nutritional Status in Locoregionally Advanced Nasopharyngeal Carcinoma Patients: Prospective Observational Study
- 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 an prospective，open-label, none-interventional, observational， multicenter phase II clinical trial. The purpose of this study is to observe the effect of neoadjuvant chemotherapy followed by concurrent chemoradiation therapy(CCRT) on nutritional status in locoregionally advanced nasopharyngeal carcinoma(NPC) patients, analyse the changes of patients' nutrition status during the treatment and the connection between nutrition changes and curative effects, evaluate nutritional risks under the neoadjuvant chemotherapy and CCRT and provide data and basis for further study。
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 |
|---|---|---|---|
| Malnutrition | — | UNRESOLVED | — |
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin and docetaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- NC+CCRT
- description
- Patients treated with neoadjuvant chemotherapy(NC) (cisplatin and docetaxel) and CCRT (cisplatin)
- interventionNames
- Drug: cisplatin and docetaxel
Primary outcomes (1)
- measure
- Change in Body weight
- timeFrame
- baseline and 36 months
Secondary outcomes (9)
- measure
- Acute Toxicity
- timeFrame
- 3 months
- description
- To evaluate the acute toxicity with Common Terminology Criteria For Adverse Events (CTCAE) 3.0 when adjuvant chemotherapy and concurrent chemoradiation is used.
- measure
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) * All genders，range from 18～65 years old * Karnofsky performance status(KPS) ≥ 80 * Clinical stage III\~IVb(UICC 7th) * 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) ≥ 10g/L, platelet(PLT) count ≥ 100×109/L * alanine aminotransferase (ALT) or aspartate aminotransferase(AST) \< 1.5×upper limit of normal(ULN), bilirubin \< 1.5×ULN, alanine aminotransferase (CCR) ≥ 30ml/min * Inform consent form Exclusion Criteria: * Distance metastases * Second malignancy within 5 years * Drug or alcohol addition * Do not have full capacity for civil acts * Active systemic infections * Chronic consumptions * Mental disorder * Pregnancy or lactation * Concurrent immunotherapy or hormone therapy for other diseases * Severe complication, eg, uncontrolled hypertension
References
Publications (1)
- DERIVEDMiao J, Wang L, Ong EHW, Hu C, Lin S, Chen X, Chen Y, Zhong Y, Jin F, Lin Q, Lin S, Hu X, Zhang N, Wang R, Wang C, Guo X, Yit NLF, Shi H, Tan SH, Mai H, Xie C, Chua MLK, Zhao C. Effects of induction chemotherapy on nutrition status in locally advanced nasopharyngeal carcinoma: a multicentre prospective study. J Cachexia Sarcopenia Muscle. 2023 Apr;14(2):815-825. doi: 10.1002/jcsm.13196. Epub 2023 Mar 5. PMID 36872457