Clinical trial NCT02575547: Effect of Chemoradiotherapy on Nutritional Status in Advanced NPC Patients
Official title: Effect of Neoadjuvant Chemotherapy Followed by Concurrent Chemo-radiotherapy on Nutritional Status in Locoregionally Advanced Nasopharyngeal Carcinoma Patients: Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasopharyngeal Carcinoma
Malnutrition
Keywords: Nutritional Status
Locoregionally Advanced Nasopharyngeal Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Wuhan University
name: Fudan University
name: Fujian Cancer Hospital
name: Zhejiang Cancer Hospital
name: First Affiliated Hospital of Guangxi Medical University
name: The First Affiliated Hospital of Xiamen University
name: Cancer Hospital of Guizhou Province
name: Hainan People's Hospital
name: First People's Hospital of Foshan
First posted: 2015-10-14
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: III-IVb(Union for International Cancer Control,UICC 7th) NPC patients with histologic diagnosis of World Health Organization(WHO) II

Brief summary: 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。


Eligibility criteria: 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

Primary outcomes:
measure: Change in Body weight
timeFrame: baseline and 36 months
Secondary outcomes:
measure: Acute Toxicity
timeFrame: 3 months
measure: Number of Participants With Abnormal Laboratory Values
timeFrame: 36 months
measure: Adverse Events That Are Related to Treatment
timeFrame: 36 months
measure: Tumor regressive rate after treatment
timeFrame: 36 months
measure: Late toxicity
timeFrame: 36 months
measure: Three-year locoregional relapse free survival rate
timeFrame: 36 months
measure: Three-year distance metastasis free survival rate
timeFrame: 36 months
measure: Three-year overall survival rate
timeFrame: 36 months
measure: Three-year disease free survival rate
timeFrame: 36 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Chong Zhao, M.D
role: PRINCIPAL_INVESTIGATOR
References: