Effect of Chemoradiotherapy on Nutritional Status in Advanced NPC Patients

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Brief Title

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

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。

Study Type

Observational

Primary Outcome

Change in Body weight

Secondary Outcome

 Acute Toxicity

Condition

Nasopharyngeal Carcinoma

Intervention

cisplatin and docetaxel

Study Arms / Comparison Groups

 NC+CCRT
Description:  Patients treated with neoadjuvant chemotherapy(NC) (cisplatin and docetaxel) and CCRT (cisplatin)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

186

Start Date

June 2015

Completion Date

June 2020

Primary Completion Date

January 2020

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

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Chong Zhao, M.D, ,

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT02575547

Organization ID

2015-FXY-034-Nutrition and NPC

Responsible Party

Sponsor-Investigator

Study Sponsor

Zhao Chong

Collaborators

 Wuhan University

Study Sponsor

Chong Zhao, M.D, Principal Investigator, Sun Yat-sen University

Verification Date

July 2020