Effect of Chemoradiotherapy on Nutritional Status in Advanced NPC Patients

Malnutrition Clinical Trial

Official title:

Effect of Neoadjuvant Chemotherapy Followed by Concurrent Chemo-radiotherapy on Nutritional Status in Locoregionally Advanced Nasopharyngeal Carcinoma Patients: Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02575547
• Other study ID #: 2015-FXY-034-Nutrition and NPC
• Status: Completed
• Start date: June 2015
• Est. completion date: June 2020

Study information

• Verified date: July 2020
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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。

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: June 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Malnutrition
• Nasopharyngeal Carcinoma

Intervention

Drug:
• cisplatin and docetaxel
NC:cisplatin 75 mg/m2 intravenous infusion in day1,docetaxel 75 mg/m2 intravenous infusion in day1,both drugs are given every 3 weeks, two courses. CCRT: intensity modulation radiation therapy(IMRT) and cisplatin (100mg/m2 on day 1) every three weeks for three\three cycles during radiation therapy(RT). Dietary supplement: enteral nutrition and parenteral nutrition

Locations

Country	Name	City	State
China	Cancer Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (10)

Lead Sponsor	Collaborator
Zhao Chong	Cancer Hospital of Guizhou Province, First Affiliated Hospital of Guangxi Medical University, First People's Hospital of Foshan, Fudan University, Fujian Cancer Hospital, Hainan People's Hospital, The First Affiliated Hospital of Xiamen University, Wuhan University, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body weight		baseline and 36 months
Secondary	Acute Toxicity	To evaluate the acute toxicity with Common Terminology Criteria For Adverse Events (CTCAE) 3.0 when adjuvant chemotherapy and concurrent chemoradiation is used.	3 months
Secondary	Number of Participants With Abnormal Laboratory Values	To observe patients' complete blood cell count and blood biochemical examination during the treatment and three years after the treatment.	36 months
Secondary	Adverse Events That Are Related to Treatment	Using European Organization for Research and Treatment of Cancer(EORTC) quality of life questionnaire(QLQ)-C30(version 3.0) and EORTC QLQ-H&N35(Version 1.0) to access the quality of life. Collecting data before treatment, 1 week after each 4/5 cycles of chemotherapy, 3 years after all treatment finished.	36 months
Secondary	Tumor regressive rate after treatment		36 months
Secondary	Late toxicity	To evaluate the late toxicity with the SOMA criterion after 1/2/3 years of treatment.	36 months
Secondary	Three-year locoregional relapse free survival rate		36 months
Secondary	Three-year distance metastasis free survival rate		36 months
Secondary	Three-year overall survival rate		36 months
Secondary	Three-year disease free survival rate		36 months

External Links

•   Home Page of Cancer Center, Sun Yat-sen University